ObsEva SA (NASDAQ: OBSV / SIX: OBSN) a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced the presentation of five e-Posters on linzagolix in the treatment of uterine fibroids at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting (ACSM), which will take place virtually from April 30 to May 2, 2021.
The data presented further substantiate the best-in-class potential of linzagolix for the treatment of heavy menstrual bleeding (HMB) due to uterine fibroids addressing both key efficacy and safety parameters from the PRIMROSE Phase 3 program.
The posters being presented, along with lead authors and key conclusions are:
Effects of the oral GnRH antagonist linzagolix on uterine and fibroid volume in two Phase 3 trials
Lead author: Jacques Donnez, MD, PhD; Professor, Société de Recherche pour l'Infertilité (SRI), Brussels and Catholic University of Louvain, Belgium
Key Conclusions: The 200 mg dose of linzagolix without hormonal add-back therapy (ABT) was the only dose to show consistent substantial and significant reductions in uterine and fibroid volumes. Linzagolix is the only GnRH antagonist with a high-dose non-ABT option with the potential for short-term use for reduction of uterine and fibroid volume.
Impact of linzagolix on pain in patients with fibroid-related heavy menstrual bleeding: results of two Phase 3 trials
Lead author: Ayman Al-Hendy, MD, Ph.D.; Professor, Department of Obstetrics and Gynecology, University of Chicago
Key Conclusions: Linzagolix 100 and 200 mg, with and without ABT, consistently improved pain in women with fibroid-associated HMB. Pain reduction in the treatment groups was achieved after 12 weeks and was maintained up to 52 weeks. By 12 weeks following termination of treatment, pain scores had increased but had not reached baseline levels.
Impact of linzagolix treatment on anemia in women with uterine fibroid related heavy menstrual bleeding: results of two Phase 3 clinical trials
Lead author: William Catherino, MD, Ph.D.; Professor, Department of Gynecologic Surgery and Obstetrics, Uniformed Services University of the Health Sciences
Key Conclusions: High and low linzagolix doses with and without ABT improved hemoglobin and ferritin levels in anemic women with uterine fibroids. In the 12-week follow-up period hemoglobin levels decreased but did not return to baseline levels.
Safety of linzagolix in the treatment of women with uterine fibroids: Results from two Phase 3 clinical trials
Lead author: Hugh Taylor, MD; Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine
Key Conclusions: Overall treatment emergent adverse event (TEAE) rates at 24 weeks were similar to placebo for the linzagolix 100 mg and 200 mg with ABT regimens. Lumbar spine bone mineral density (BMD) z-scores indicated no change in risk categories. TEAE rates at Week 24 and BMD up to 52 weeks support the potential for long-term use of linzagolix 100 mg and 200 mg with ABT.
Impact of linzagolix on events of depression and other mood disorders in women with uterine fibroids
Lead author: Robert Taylor, MD, Ph.D.; Professor, Obstetrics and Gynecology, University at Buffalo
Key Conclusions: In the Phase 3 uterine fibroids trials of linzagolix, the incidence of depression and other mood disorder adverse events was low and revealed no consistent drug-related pattern.
All ePosters will be displayed on the ACOG Annual Meeting virtual platform in gallery view with search features by title, topic, and category. Each ePoster will have a dedicated page that will include a 5-minute prerecorded ePoster preview.
About Uterine Fibroids
Uterine fibroids are common benign tumors of the muscular tissue of the uterus. Uterine fibroids affect women of childbearing age and can vary in size from undetectable to large bulky masses. Few long-term medical treatments are available, and as a result, approximately 300,000 hysterectomies are performed for uterine fibroids every year in the US. The symptoms of uterine fibroids are wide-ranging and include heavy menstrual bleeding, anemia, pelvic pressure and bloating, urinary frequency, and pain that can be extremely debilitating with a significant impact on quality of life. These symptoms can also have an impact on mental health, creating the additional burden of anxiety and distress.
ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’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, and preterm labor. 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.
About Yselty® (Linzagolix)
Yselty® (linzagolix) is a novel, once-daily, oral GnRH receptor antagonist with a potentially best-in-class profile. Linzagolix is currently in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis. ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product. Linzagolix is not currently approved anywhere in the world.
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.
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 other similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the potential therapeutic benefits and 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 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, related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, the impact of the novel coronavirus outbreak, 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, 2020 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.