ObsEva S.A.  

Plan-les-Ouates,  Geneva 
Switzerland
http://www.obseva.com
  • Booth: 1005

ObsEva is a clinical-stage biopharmaceutical company dedicated to women’s health. We are passionately focused on innovation to address serious, quality-of-life impacting conditions and reproductive challenges faced by women worldwide. Our lead compound is nolasiban, an oral oxytocin receptor antagonist, potentially first-in-class, delivering more IVF babies by improving embryo implantation. Our second product, linzagolix, an oral gonadotropin releasing hormone (GnRH) receptor antagonist, is potentially the best-in-class in treating uterine fibroids and endometriosis thanks to the option to treat with or without hormone replacement therapy. Finally, OBE022, an oral and selective prostaglandin F2alpha receptor antagonist, has the potential to save newborn lives by avoiding preterm delivery.


 Press Releases

  • Geneva, Switzerland and Boston, MA – July 26, 2019 – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today announced that the Independent Data Monitoring Committee (IDMC) has completed the unblinded review of data from the first 30 subjects randomized in Part B of the PROLONG trial in preterm labor with PGF2a receptor antagonist OBE022. An IDMC is an independent panel of experts who periodically review clinical trial data to ensure that the interests of the patients are being well-served and that the scientific integrity of the trial is maintained.

    In the PROLONG trial, OBE022 or matching placebo is administered daily for 7 days to pregnant women who are receiving an infusion of atosiban for 48 hours, the current standard of care therapy for preterm labor in the countries in which the PROLONG trial is being conducted. The goal is to assess the efficacy, safety and pharmacokinetics of OBE022 in patients with threatened spontaneous preterm labor.

    “We are very pleased to have initial feedback from the Part B of the PROLONG trial,” said Ernest Loumaye, co-founder and Chief Executive Officer of ObsEva. “The IDMC reviewed the data from the first 30 subjects randomized in PROLONG and recommended to continue the trial without modifications. This is very positive feedback on OBE022, a potential first-in-class molecule being developed for the treatment of preterm labor, and we continue progressing towards the completion of the trial with the next IDMC review expected with data from 60 patients later this year. ”

    PROLONG is a proof-of-concept Phase 2a clinical trial conducted in two parts: Part A and Part B.

    Part A was an open-label single arm trial of OBE022 administered orally for 7 days to pregnant women with nine subjects enrolled. OBE022 was well tolerated by the mothers and their fetuses and the pharmacokinetics of OBE022 were similar to those previously observed in non-pregnant women.

    Part B, is a randomized, double-blind, placebo-controlled, parallel-group trial to assess the efficacy, safety and pharmacokinetics of OBE022. The trial will recruit 120 patients with preterm labor at a gestational age of 24 to 34 weeks. OBE022 or placebo is administered orally, with 1000 mg as a starting dose, then 500 mg twice a day for 7 days to women already receiving a standard-of-care therapy for threatened preterm labor, an atosiban infusion for 48 hours. The regimen is the same as in Part A.

    Part B is being conducted in Czech Republic, Finland, Israel, Russia, Spain and Vietnam.

     

    About Preterm Labor

    Preterm labor, defined as the birthing process starting prior to 37 weeks of gestation, is a serious condition characterized by uterine contractions, cervical dilation and rupture of the fetal membranes that can lead to preterm birth. According to a study published in the Lancet in 2012, approximately 15 million babies were born before 37 weeks of gestation in 2010, accounting for 11.1% of all live births worldwide. Over 1 million children under the age of five died in 2013 worldwide due to preterm birth complications, and many infants who survive preterm birth are at greater risk for cerebral palsy, delays in development, hearing and vision issues, and often face a lifetime of disability. The rates of preterm births are rising in almost all countries with reliable data for preterm birth, and are associated with an immense financial impact to the global healthcare system.

    To date, only treatments with limited efficacy or restrictive safety issues are available to treat preterm labor. In the United States, no drugs are approved for acute treatment of PTL and recommended off-label tocolytic treatments (medications that inhibit labor) include beta-adrenergic receptor agonists, calcium channel blockers, or NSAIDs, which are used for short-term prolongation of pregnancy (up to 48 hours) to allow for the administration of antenatal steroids (e.g. betamethasone). Magnesium sulfate, used for fetal neuroprotection can also be used (up to 48 hours) to inhibit acute preterm labor. Approved tocolytic treatments in Europe include beta-adrenergic agonists, which carry severe maternal cardiovascular risks, and intravenous infusions of atosiban (an oxytocin receptor antagonist).

    While prostaglandin inhibitors (NSAIDs) have been shown to be effective for inhibiting preterm labor, use of such drugs is limited, due to the threat of serious and sometimes life-threatening side effects in the fetus. Such side effects may include kidney function impairment, premature constriction of the blood vessel  connecting the pulmonary artery and the descending aorta in a developing fetus (ductus arteriosus), and higher risk of thrombosis of the intestinal arteries (a condition called necrotizing enterocolitis).

     

     

    About OBE022 and PGF2alpha

    ObsEva is developing OBE022, a potential first-in-class, once daily, oral and selective prostaglandin F2alpha receptor antagonist, which is designed to control preterm labor by reducing inflammation, decreasing uterine contractions, preventing cervical changes and fetal membrane rupture without causing the potentially serious side effects to the fetus seen with non-specific prostaglandin synthesis inhibitors (NSAIDs). PGF2alpha is believed to induce contractions of the myometrium and also upregulate enzymes causing cervix dilation and membrane rupture. In nonclinical studies, ObsEva has observed that OBE022 markedly reduces spontaneous and induced uterine contractions in pregnant rats without causing the fetal side effects seen with prostaglandin inhibitors such as indomethacin.

     

    About ObsEva

    ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving IVF outcomes. ObsEva is listed on the NASDAQ Global Select Market and is trading under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.

     

    Cautionary Note Regarding Forward Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan,” “potential,” “will,” and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of OBE022 and the timing of enrollment in and data from clinical trials. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and clinical development, including the risk that the results of earlier clinical trials may not be predictive of the results of later-stage clinical trials, ObsEva’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2018, and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at http://www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

     

    For further information, please contact: 

    Media Contact Switzerland and Europe:

    Christophe Lamps

    Dynamics Group

    cla@dynamicsgroup.ch

    +41 22 308 6220 Office

    +41 79 476 26 87 Mobile

    Media Contact U.S.:

    Marion Janic

    RooneyPartners LLC

    mjanic@rooneyco.com

    +1 212 223 4047 Office

    +1 646 537 5649 Mobile

    CEO Office Contact:

    Shauna Dillon

    Shauna.dillon@obseva.ch

    +41 22 552 1550

    Investor Contact: 

    Mario Corso

    Senior Director, Investor Relations

    mario.corso@obseva.com

    +1 857 972 9347 Office

    +1 781 366 5726 Mobile

    ###

  • Company remains on track to submit Nolasiban MAA in the fourth quarter of 2019

     

    GENEVA, Switzerland and BOSTON, MA –  July 17, 2019 – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today hosted a key opinion leader (KOL) meeting in New York City on in-vitro fertilization (IVF). 

    At the event, three KOLs in women’s reproductive health along with company executives discussed trends in IVF, including current practice trends toward Day 5 embryo transfer, and the merits of single-embryo transfer (SET) vs. double embryo transfer (DET).  Further, event participants discussed the potential clinical importance of nolasiban, ObsEva’s oral oxytocin receptor antagonist, to significantly improve the live birth rate (LBR) resulting from ET, and address the high physical, emotional and financial pain associated with failed cycles.  ObsEva also provided perspectives on commercializing nolasiban in both the U.S. and Europe. 

    “We were honored to be joined today by three esteemed physicians from across the U.S. to discuss the IVF practice landscape and were delighted to have the opportunity to speak about nolasiban, our lead clinical candidate.  Nolasiban is currently being evaluated in a Phase 3 trial in Europe, IMPLANT 4, and we are in discussion with the U.S. Food and Drug Administration (FDA) regarding a planned Phase 3 study in the U.S., IMPLANT 3, which we expect to begin late this year or early next year,” said Ernest Loumaye, M.D., Ph.D., co-founder and Chief Executive Officer of ObsEva.

    “ART and IVF are growing in importance at the global level, and with that growth is an evolving standard-of-care that aims to improve outcomes for women who are looking to conceive,” he added.  “Approximately 9% of women age 20-44 are affected by infertility, and despite good-quality embryos and best practice transfer techniques, IVF success rates are not optimal.  Indeed, according to the 2016 Assisted Reproductive Technology Report from the CDC, a majority of embryo transfers still involve multiple embryos (mainly double), which too frequently result in multiple births. Despite that, women who have an embryo transfer still have less than 50% chance to take home a baby.”

    Senior executives from ObsEva’s management team were joined at today’s event by KOLs:

    • Samuel Pauli, M.D., Reproductive Endocrinologist and Surgical Director at Boston IVF;
    • Vicki Schnell, M.D, Founder & Medical Director at the Center of Reproductive Medicine in Houston, TX; and
    • Fady I. Sharara, M.D, Medical Director at the Virginia Center of Reproductive Medicine in Reston, VA.

    “The number of IVF cycles continues to rapidly increase in the U.S. and worldwide. In addition, while practice trends have evolved in recent years, we must strive to do even better, as overall success rates below 50% and are even lower with increasing age.  This is not acceptable, and we must keep working to do better through innovation and new approaches,” said Dr. Schnell.

     

    Dr. Pauli commented, “Despite CDC and SART guidelines supporting SET, a significant number of embryo transfers are still DET to improve the chance of IVF success. A treatment like nolasiban that could meaningfully improve the success of SET would further encourage SET utilization. This would reduce the negative consequences of DET-associated multiple births and related medical risks and healthcare costs.” 

     

    Dr. Sharara added “It is very difficult for most people to comprehend the downside of cycle failure unless they have direct experience. In addition to the significant financial hurdles that patients face during their long journey to pregnancy and delivery of a baby, the emotional impact of failure is devastating and life altering.”

    An archived webcast of the event including slides is available here.

    About Assisted Reproductive Technology

    Infertility affects about 10% of reproductive-aged couples, with more than 2 million ART treatments (including IVF and ICSI) performed worldwide each year. Currently 62% of fresh embryo transfers are performed on Day 5 and 30% on Day 3 in the United States (CDC report, 2016 data).

    While the success of ART depends on multiple factors including ovarian response, fertilization, embryo quality and ET procedure, a successful pregnancy ultimately hinges on the receptivity of the uterus to accept embryo implantation.  Uterine contractions at the time of ET, as well as suboptimal thickness of the uterine wall and insufficient blood flow to the uterus, may impair the implantation of the embryo.

     

    About Nolasiban

    Nolasiban (previously known as OBE001), is an oral oxytocin receptor antagonist with the potential to decrease uterine contractions, improve uterine blood flow and enhance the receptivity of the endometrium to embryo implantation, all of which may increase the chance of successful pregnancy and live birth among women undergoing ART. ObsEva licensed nolasiban from Merck KGaA in 2013 and retains worldwide, exclusive commercial rights.

    About IMPLANT 4

    Begun in November 2018, the IMPLANT 4 trial is a placebo-controlled, double blind Phase 3 trial to be conducted in 49 clinical sites in 10 countries primarily in Europe, as well as in Canada and Russia.  Planned enrollment is approximately 800 patients who are undergoing an IVF cycle with a Day 5 SET. Eligible women will be randomized in a 1:1 ratio to receive either a single oral 900 mg dose of nolasiban or placebo four hours prior to ET.

    The primary endpoint of the IMPLANT 4 trial is the proportion of patients successfully achieving ongoing pregnancy 10 weeks post ET.  Live birth rate is a secondary endpoint of the trial, and follow-up will include 28-day neonatal assessment, as well as infant development assessment at 6 and 12 months post-birth.  A successful IMPLANT 4 study will support a Marketing Authorization Application (MAA) in Europe, Canada, Russia and other countries such as Switzerland.

    About ObsEva

    ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving IVF outcomes. ObsEva is listed on the NASDAQ Global Select Market and is trading under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.obseva.com.

     

    Cautionary Note Regarding Forward Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan,” “potential,” “will,” and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of ObsEva’s product candidates, the timing of enrollment in and data from clinical trials, the results of interactions with regulatory authorities, and the potential efficacy and commercialization of our product candidates. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, clinical development and related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, risks and uncertainties regarding challenges in launching or commercializing our product candidates, including issues related to market acceptance and reimbursement, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2018, and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

     

    For further information, please contact

    Media Contact Switzerland and Europe:

    Christophe Lamps

    Dynamics Group

    cla@dynamicsgroup.ch

    +41 22 308 6220 Office

    +41 79 476 26 87 Mobile

    Media Contact U.S.

    Marion Janic

    RooneyPartners LLC

    mjanic@rooneyco.com

    +1 212 223 4047 Office

    +1 646 537 5649 Mobile

    CEO Office Contact

    Shauna Dillon

    Shauna.dillon@obseva.ch

    +41 22 552 1550

    Investor Contact

    Mario Corso

    Senior Director, Investor Relations

    mario.corso@obseva.com

    +1 857 972 9347 Office

    +1 781 366 5726 Mobile

    #   #   #

  • Geneva, Switzerland and Boston, MA – July 8, 2019 – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today reported completion of patient recruitment of its Phase 3 clinical trial PRIMROSE 1 evaluating oral gonadotropin releasing hormone (GnRH) receptor antagonist linzagolix for the treatment of heavy menstrual bleeding (HMB) associated with uterine fibroids (UF).

    PRIMROSE 1 is being conducted at 117 sites, in the United States, randomizing approximately 500 patients with a diagnosis of HMB associated with UF. Eligible patients are either receiving a once daily dose of 100 mg or 200 mg of linzagolix, or they are receiving a placebo. Active treatment arms are being tested with and without low doses of hormonal add-back therapy (ABT). Patients are treated for up to 52 weeks to evaluate the safety of long-term treatment. A second Phase 3 clinical trial, PRIMROSE 2, is also being run in parallel in the U.S. and Europe— the trial is testing the same treatment arms at 102 sites where approximately 500 patients have also been randomized.

    The completion of patient recruitment for our second pivotal Phase 3 PRIMROSE 1 trial represents a key step toward the development of linzagolix for the treatment of uterine fibroids,” said Ernest Loumaye, co-founder and Chief Executive Officer of ObsEva. “Linzagolix is the only GnRH receptor antagonist developed in UF with a dosing option without concomitant administration of ABT to achieve sustained symptom relief and one with concomitant ABT administration. We expect to report six-month primary endpoint data from the PRIMROSE 2 and PRIMROSE 1 trials in the fourth quarter of 2019 and in the first half of 2020, respectively.”

    About the PRIMROSE 1 Clinical Trial

    PRIMROSE 1 is a pivotal, randomized, double blind, placebo controlled, Phase 3 clinical trial assessing the efficacy and safety of a novel oral GnRH receptor antagonist linzagolix in patients with heavy menstrual bleeding associated with uterine fibroids.

    The primary endpoint of PRIMROSE 1 is a clinically meaningful and statistically significant reduction in menstrual bleeding as assessed by the alkaline hematin method, a validated, quantitative measurement of menstrual blood loss. The primary endpoint efficacy results are anticipated in 1H 2020.

    About Uterine Fibroids

    Uterine fibroids are common non-cancerous tumors that grow within the muscular wall of the uterus. They can vary in size and number and when symptomatic, are most often accompanied by heavy menstrual bleeding (HMB), anemia, abdominal pressure and pain, bloating, increased urinary frequency and reproductive dysfunction. Uterine fibroids are associated with an increased risk of pregnancy complications such as infertility, miscarriage, placental abruption and early onset of labor. According to a study published in the American Journal of Obstetrics & Gynecology in 2003, uterine fibroids affect an estimated 20 to 40 percent of women over the age of 30 in the United States based on clinical cases and women who undergo treatment.

    For the millions of women with symptomatic uterine fibroids seeking treatment options, selection is driven by symptom severity, the woman’s age, and her desire to have children now or in the future. While medical, surgical and minimally invasive treatments are available, the standard of care for symptomatic uterine fibroids is a hysterectomy or, in women who wish to preserve their fertility, surgical removal of the fibroid(s).

    About linzagolix (formerly OBE2109)

    Linzagolix is a novel, orally administered GnRH receptor antagonist with a potentially best-in-class profile in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis. Linzagolix acts by binding to and blocking the GnRH receptor in the pituitary gland, ultimately reducing estrogen production by the ovaries. Through previously reported results from linzagolix and sophisticated pharmacological modelling, it has been established that maintaining estradiol within a specific target range provides the optimal balance between reducing symptoms while mitigating bone density loss associated with excessive estradiol suppression. ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for linzagolix.

    About Kissei

    Kissei is a Japanese pharmaceutical company with approximately 70 years of history, specialized in the field of urology, kidney – dialysis and Unmet Medical Needs. Silodosin is a Kissei product for the treatment of the signs and symptoms of benign prostatic hyperplasia which is sold worldwide through its licensees. KLH-2109/OBE2109 is a new chemical entity discovered by Kissei R&D.

    About ObsEva

    ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving IVF outcomes. ObsEva is listed on the Nasdaq Global Select Market and is trading under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.obseva.com.

    Cautionary Note Regarding Forward Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan,” “potential,” “will,” and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of ObsEva’s product candidates. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, clinical development and related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2018, and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at http://www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    For further information, please contact:

    Media Contact Switzerland and Europe:

    Christophe Lamps

    Dynamics Group

    cla@dynamicsgroup.ch

    +41 22 308 6220 Office

    +41 79 476 26 87 Mobile

    Media Contact U.S.:

    Marion Janic

    RooneyPartners LLC

    mjanic@rooneyco.com

    +1 212 223 4047 Office

    +1 646 537 5649 Mobile

    CEO Office Contact:

    Shauna Dillon

    Shauna.dillon@obseva.ch

    +41 22 552 1550

    Investor Contact:

    Mario Corso

    Senior Director, Investor Relations

    mario.corso@obseva.com

    +1 857 972 9347 Office

    +1 781 366 5726 Mobile

  • Geneva, Switzerland and Boston, MA – June 4, 2019 – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today reported completion of patient recruitment of IMPLANT 4 Phase 3 clinical trial of its oral oxytocin receptor antagonist, nolasiban, for the improvement of rates of pregnancy and live birth in patients undergoing embryo transfer (ET) following assisted reproduction technology (ART), or in-vitro fertilization (IVF).

    IMPLANT 4 is being conducted at 48 sites, in Europe, Canada and Russia, randomizing approximately 820 patients undergoing embryo transfer following IVF. Eligible women are receiving either a single oral 900 mg dose of nolasiban or placebo four hours prior to a Day 5 single embryo transfer (SET). Key efficacy endpoints of the IMPLANT 4 trial are the proportion of patients achieving ongoing pregnancy 10 weeks post embryo transfer (ET) and live birth rate (LBR), and follow-up will include 28-day neonatal assessment, as well as infant development assessment at 6 and 12 months post-birth.  Positive primary endpoint results for IMPLANT 4 in the fourth quarter of 2019 would confirm the prior positive IMPLANT 2 trial results, and allow ObsEva to proceed with a Marketing Authorization Application in Europe.

    We are very pleased by the completion of patient recruitment for the IMPLANT 4 trial, an important step toward bringing nolasiban to patients undergoing the demanding procedure of IVF, and improving their chances to take home a baby,” said Ernest Loumaye, co-founder and Chief Executive Officer of ObsEva“With a successful IMPLANT 4 outcome and planned MAA in Europe, ObsEva is evolving into a commercial company with a unique and innovative product that may not only help patients, but has the potential to lower associated healthcare costs.”

    About Assisted Reproductive Technology (ART)

    Infertility affects about 10 % of reproductive-aged couples, with more than 2 million ART treatments (including IVF and ICSI) performed worldwide each year. Currently 62% of fresh embryo transfers are performed on Day 5 and 30% on Day 3 in the United States (CDC report, 2016 data).

    While the success of ART depends on multiple factors such as embryo quality and ET procedure, a successful pregnancy ultimately hinges on the receptivity of the uterus to accept embryo implantation.

    Uterine contractions at the time of ET, as well as suboptimal thickness of the uterine wall and blood flow to the uterus, may impair the implantation of the embryo.

    About Nolasiban

    Nolasiban (previously known as OBE001), is an oral oxytocin receptor antagonist with the potential to decrease uterine contractions, improve uterine blood flow and enhance the receptivity of the endometrium to embryo implantation, all of which may increase the chance of successful pregnancy and live-birth among patients undergoing ART. ObsEva licensed nolasiban from Merck KGaA, Darmstadt, Germany, in 2013 and retains worldwide, exclusive, commercial rights.

    About ObsEva

    ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving IVF outcomes. ObsEva is listed on the NASDAQ Global Select Market and is trading under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.

    Cautionary Note Regarding Forward Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan,” “potential,” “will,” and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of ObsEva’s product candidates, data from clinical trials and the results of interactions with regulatory authorities. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, clinical development and related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2018, and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    For further information, please contact:

    Media Contact Switzerland and Europe:

    Christophe Lamps

    Dynamics Group

    cla@dynamicsgroup.ch
    +41 22 308 6220 Office
    +41 79 476 26 87 Mobile

  • Geneva, Switzerland and Boston, MA – May 9, 2019 – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today announced initiation of the Phase 3 development program of its orally administered, gonadotropin-releasing hormone (GnRH) receptor antagonist, linzagolix, for the treatment of endometriosis-associated pain, which includes the EDELWEISS 2 and EDELWEISS 3  clinical trials.

     “We are very pleased to announce the initiation of pivotal Phase 3 trials for linzagolix in endometriosis associated pain which, if successful, will form the basis for our registration in the U.S. and Europe for that indication. We believe that linzagolix has the potential to be a best in class oral GnRH antagonist providing women with dosing options both with and without ABT to manage their condition ,” said Dr. Loumaye, co-founder and Chief Executive Officer of ObsEva.

    EDELWEISS 2 and 3 are randomized placebo-controlled, double blind, pivotal Phase 3 trials for 6 months, which will assess the efficacy and safety of linzagolix in patients with moderate to severe endometriosis-associated pain. Upon completion of the trials, eligible patients may enter a randomized 6 months extension trial in which they will receive only linzagolix followed by a 6 months post-treatment follow-up. Both trials are of identical design and are testing two dosing options: a 75mg single dose of linzagolix without low dose hormonal Add Back Therapy (ABT) and a 200mg single dose of linzagolix with ABT. Approximately 900 patients in total are expected to participate in the two trials. The EDELWEISS 2 study is being conducted in the U.S. and Canada, while EDELWEISS 3 is running in the U.S. and Europe.

    About linzagolix (formerly OBE2109)

    Linzagolix is a novel, orally administered GnRH receptor antagonist with a potentially best-in-class profile in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis. Linzagolix acts by binding to and blocking the GnRH receptor in the pituitary gland, ultimately resulting in a dose-dependent reduction of the estrogen production by the ovaries. Through previously reported results from linzagolix and sophisticated pharmacological modelling, it has been established that maintaining estradiol within a specific target range provides the optimal balance between reducing symptoms while mitigating bone density loss associated with excessive estradiol suppression. ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for linzagolix.

    About Kissei

    Kissei is a Japanese pharmaceutical company with approximately 70 years of history, specialized in the field of urology, kidney-dialysis and unmet medical needs. Silodosin is a Kissei product for the treatment of the signs and symptoms of benign prostatic hyperplasia which is sold worldwide through its licensees. KLH-2109/OBE2109/linzagolix is a new chemical entity discovered by Kissei R&D and currently in development in Japan by Kissei.

    About ObsEva

    ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving IVF outcomes. ObsEva is listed on the Nasdaq Global Select Market and is trading under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.obseva.com.

    Cautionary Note Regarding Forward Looking Statements

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan,” “potential,” “will,” and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of ObsEva’s product candidates,  the timing of enrollment in and data from clinical trials and the results of interactions with regulatory authorities. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, clinical development and related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2018, and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at http://www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

    For further information, please contact:

    Media Contact Switzerland and Europe:
    Christophe Lamps
    Dynamics Group
    cla@dynamicsgroup.ch
    +41 22 308 6220 Office
    +41 79 476 26 87 Mobile

    Media Contact U.S.:
    Marion Janic
    RooneyPartners LLC
    mjanic@rooneyco.com
    +1 212 223 4047 Office
    +1 646 537 5649 Mobile

    CEO Office Contact:
    Shauna Dillon
    Shauna.dillon@obseva.ch
    +41 22 552 1550

    Investor Contact:
    Mario Corso
    Senior Director, Investor Relations
    mario.corso@obseva.com
    +1 857 972 9347 Office
    +1 781 366 5726 Mobile


 Products

  • Nolasiban
    Nolasiban an oral oxytocin receptor antagonist, is potentially first-in-class, delivering more IVF babies by improving embryo implantation...

  • Nolasiban, has the potential to decrease uterine contractions, improve uterine blood flow and enhance the endometrium receptivity to embryo implantation, all of which may increase the chance of successful pregnancy and live-birth among patients undergoing ART.

    Positive Phase 3 results (IMPLANT 2) were released in 2018, demonstrating that nolasiban treatment resulted in a statistically, clinically significant improvement in live birth rate supporting a number needed to treat (NNT) of 9. On June 4, 2019, ObsEva announced completion of patient recruitment in IMPLANT 4, the confirmatory Phase 3 trial, evaluating the impact of nolasiban on rates of pregnancy and live birth in approx. 820 women undergoing single ET on Day 5 following IVF. Primary end point results are anticipated in 4Q2019. Subject to a positive outcome of this trial, ObsEva expects to submit an MAA in Europe.

    ObsEva licensed nolasiban from Merck KGaA, Germany, in 2013 and retains worldwide, exclusive, commercial rights.
  • Linzagolix
    Linzagolix, an oral GnRH receptor antagonist, is potentially the best-in-class in treating uterine fibroids and endometriosis thanks to the option to treat either with or without hormone replacement therapy...

  • Linzagolix acts by binding to and blocking the GnRH receptor in the pituitary gland, ultimately reducing estrogen production by the ovaries. Through previously reported results from linzagolix and sophisticated pharmacological modelling, it has been established that maintaining estradiol within a specific target range provides the optimal balance between reducing symptoms while mitigating bone density loss associated with excessive estradiol suppression.

    On July 8, 2019, ObsEva reported completion of patient recruitment of its Phase 3 clinical trial PRIMROSE 1 evaluating linzagolix for the treatment of heavy menstrual bleeding (HMB) associated with uterine fibroids (UF).

    On May 9, 2019 ObsEva announced the initiation of Phase 3 EDELWEISS 2 and 3 trials of linzagolix for endometriosis associated pain in the U.S., Canada and Europe.

    ObsEva licensed linzagolix from Kissei, Japan, in late 2015 and retains worldwide, exclusive, commercial rights, excluding Asia.
  • OBE022
    OBE022, a once daily, oral and selective prostaglandin F2alpha receptor antagonist, has the potential to be first-in-class and save newborn lives by avoiding preterm delivery...

  • ObsEva is developing OBE022 designed to control preterm labor by reducing inflammation, decreasing uterine contractions, preventing cervical changes and fetal membrane rupture without the potentially serious side effects to the fetus seen with non-specific prostaglandin synthesis inhibitors (NSAIDs). Based on successful non-clinical data supporting this hypothesis, ObsEva initiated PROLONG, a proof-of-concept Phase 2a trial, for the treatment of preterm labor.

    After encouraging results for Part A of the study showing OBE022 was well tolerated by mothers and their fetuses while 8 out of 9 patients achieved the treatment goal of seven-days without delivering their baby, Part B, a randomized controlled phase 2 study comparing OBE022 + atosiban versus atosiban in 120 patients, was initiated.

    ObsEva licensed OBE022 from Merck KGaA, Germany, in 2015 and retains worldwide, exclusive, commercial rights.