ObsEva Provides Business Outlook for 2021
GENEVA, Switzerland and BOSTON, MA (February 10, 2021) – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today provided a corporate update, including its roadmap for advancing its clinical programs in 2021.
“We made significant progress across all aspects of the company in 2020, most significantly preparing Yselty® for uterine fibroids for regulatory approval with a filed and validated European marketing authorization application and an upcoming planned new drug application in the US,” said Brian O’Callaghan, CEO of ObsEva. “Meanwhile our other pipeline programs have continued to advance through development as evidenced by the recent exciting topline results from the PROLONG Phase 2a proof-of concept study of ebopiprant which, to our knowledge, is the only candidate drug in active development that has the potential to delay delivery in women with spontaneous preterm labor.”
“While we remain committed to advancing our clinical development programs in women’s health, we are equally excited about our potential to extend into new indications that address important unmet needs in other therapeutic areas,” continued Mr. O’Callaghan. “As an example, we believe that linzagolix in combination with estrogen could potentially challenge the current standard of care as the best-in-class oral GnRH antagonist for the treatment of advanced prostate cancer. Recent M&A and partnering activity in the women’s reproductive health and prostate cancer landscape underscores the potential of these currently underserved patient populations as well as the importance of retaining, rather than relinquishing, the inherent value of our assets. As we approach multiple catalysts in 2021, we will continue to seek opportunities and partnerships that preserve our control and maximize the value of our pipeline candidates.”
Key 2021 Objectives
- Yselty® for uterine fibroids: NDA submission (Q2:21); MAA approval (Q4:21)
- Yselty® for endometriosis: Phase 3 EDELWEISS 3 primary endpoint readout (Q4:21)
- Ebopiprant for treatment of preterm labor: Phase 2b dose ranging study initiation in EU/Asia (Q4:21)
Clinical Development Details
Yselty®for Uterine Fibroids
ObsEva is developing Yselty®, an oral GnRH receptor antagonist with the potential to treat more women thanks to its potential best-in-class efficacy, a favorable tolerability profile and unique, flexible dosing options for the treatment of uterine fibroids. Following the European Medicine Agency’s (EMA) recent validation of the marketing authorization application (MAA), a major milestone toward making Yselty® available in the E.U., the Company will continue to work closely with the EMA to achieve marketing approval, projected in Q4:2021.
The second key objective for 2021 will be to submit a U.S. New Drug Application (NDA), projected in Q2:2021, that will include the Week 76 post-treatment follow-up results from the Phase 3 PRIMROSE 1 (US only; n=574) and PRIMROSE 2 (Europe and US; n=535) clinical studies. In both studies, patients with heavy menstrual bleeding (HMB) associated with uterine fibroids were administered Yselty doses of 100 mg or 200 mg, with and without hormonal add-back-therapy (ABT; 1 mg estradiol(E2)/0.5 mg norethisterone acetate (NETA) or placebo. Additional information about these studies can be found here.
“Uterine fibroids impact an estimated 9 million women in the U.S. However, as the medical needs of each woman vary, we need more individualized treatment options,” said Ayman Al-Hendy, M.D., Ph.D., Distinguished Professor of Obstetrics and Gynecology at the University of Chicago Division of the Biological Sciences. “Of the millions of women with symptomatic uterine fibroids, the majority are African American, a population with higher risk of contraindications to hormonal add-back-therapy (ABT). According to the CDC, approximately 57% of non-Hispanic African American women have obesity, which is specified in oral GnRH antagonist labeling as a risk factor for venous thromboembolism when used with add-back therapy for treatment of fibroids. In addition, when preparing for surgical intervention in women with the most severe fibroids, there is often a need for rapid uterine and fibroid volume reduction, which is best achieved using short-term high-dose treatment without ABT. The PRIMROSE studies demonstrated the potential of Yselty®’s unique non-ABT options (100 mg and 200 mg without ABT) to address these needs. Furthermore, the strong results on the full suppression dose (200 mg) with ABT showed that Yselty® could potentially offer best-in-class efficacy. ObsEva’s dedication to addressing the unique needs of the diverse uterine fibroids population is welcomed and encouraging.”
The EDELWEISS 3 trial in the EU is progressing as planned, with primary endpoint data expected in Q4: 2021. The ongoing Phase 3 EDELWEISS 3 study (Europe and US) was designed to enroll approximately 450 patients with endometriosis-associated pain, with a co-primary endpoint of response on both dysmenorrhea (menstrual pain) and non-menstrual pelvic pain. The study includes a 75 mg once-daily dose without hormonal ABT, and a 200 mg once-daily dose in combination with hormonal ABT (1 mg E2 / 0.5mg NETA). Subjects who completed the initial six-month treatment period will have the option to enter a six-month treatment extension. Additional information about this study can be found here.
As previously announced, the EDELWEISS 2 (US-only) study was recently discontinued due to challenges with screening and enrollment. ObsEva remains strongly committed to developing linzagolix for endometriosis, for which better long-term treatments are still needed. The Company plans to conduct a new Phase 3 endometriosis study with a number of design and operational adjustments to facilitate faster enrollment, with a goal to maintain the original MAA and NDA filing timelines for this important indication.
Ebopiprant (OBE022) for Treatment of Preterm Labor
A key objective for 2021 will be to initiate the Phase 2b program, which will build on the recently announced positive topline data from the PROLONG Phase 2a proof-of-concept study by initiating a late-stage clinical development program. Based on the unmet need, ebopiprant’s innovative mechanism of action and positive topline data regarding early clinical efficacy and safety in pregnant women with spontaneous preterm labor, and with no other known compound under development for this indication, the Company plans to discuss with European regulators a possible accelerated registration program based on a Phase 2b/3 adaptively designed trial. ObsEva is also engaging with key opinion leaders and plan to meet with the FDA in 1H2021 to discuss the development program in the US.
As previously described, delaying delivery by at least 48 hours in women with active preterm labor is critical for new treatments, as it allows for the maximum effect of corticosteroids administered to the mother for neonatal lung maturation and buys time for the mother to be transferred to a hospital with neonatal intensive care facilities with the expertise to manage the baby in case preterm delivery occurs.
In the PROLONG study, ebopiprant plus atosiban substantially reduced delivery at 48 hours after initiation of dosing by 43% compared to atosiban alone, with 12.5% of women (including women with twin gestations) receiving ebopiprant plus atosiban delivering within 48 hours of starting treatment, compared to 21.8% receiving atosiban alone (OR 90% CI: 0.52 (0.22, 1.23)). In singleton pregnancies, 12.5% of women receiving ebopiprant plus atosiban delivered within 48 hours compared to 26.8% receiving atosiban only (OR 90% CI: 0.39 (0.15, 1.04)). A modest overall effect on delivery at seven days was observed in singletons; however, there was a more pronounced effect in 24-to-30-week gestations, with 23.8% versus 14.3% of women delivering within 7 days in the atosiban alone and ebopiprant plus atosiban arms, respectively (OR 90% CI: 0.53 (0.14, 2.01)). The incidence of maternal, fetal, and neonatal adverse events was comparable between the ebopiprant group and placebo groups. Additional information about this study can be found here.
“Preterm birth rates are on the rise, yet there is no available FDA-approved treatment for preterm labor in the US. Women continue to face treatment options with limited efficacy or restrictive safety issues, and in this context the results from the Phase 2 ObsEva PROLONG study are very encouraging,” said George Saade, M.D., Professor of Obstetrics and Gynecology, Director of the Maternal-Fetal Medicine Division, as well as the Chief of Obstetrics at the University of Texas Medical Branch in Galveston. “The recently announced positive Phase 2a data demonstrated ebopiprant’s ability to reduce premature delivery within the critical timepoint of 48 hours, while potentially avoiding the serious maternal and fetal side effects associated with non-specific prostaglandin synthesis inhibitors and other medications currently used in women with preterm labor. I commend the company for taking a leadership role in addressing this longstanding serious unmet need.”
Nolasiban for In Vitro Fertilization
ObsEva is also developing nolasiban, an oral oxytocin receptor antagonist, to improve live birth rates in women undergoing in vitro fertilization. Additional information about this study can be found here.
Business Update and Financial Guidance
The Company plans to report its fourth quarter and full-year 2020 financial results in March.
David Renas, CFO of ObsEva, commented, “Since joining ObsEva, I can confirm that our team has been highly focused on maximizing the value of the company’s existing portfolio, including leveraging external assistance and securing new sources of funding, both equity and non-dilutive. Though our upcoming development and commercialization initiatives will require a variety of external support and financial resources, we are optimistic that the company’s unique product pipeline and a high level of talent will present a winning combination as we focus on this year’s objectives and beyond.”
Yselty® (linzagolix, previously known as OBE2109) is a novel, oral, once daily, GnRH receptor antagonist with a potentially best-in-class profile. Yselty 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 Yselty from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product. Yselty® is a registered trademark owned by Kissei for use by ObsEva. Yselty® is not yet approved for use anywhere in the world.
About Ebopiprant and PGF2α
ObsEva is developing ebopiprant, a potential first-in-class, once daily, oral and selective prostaglandin F2α 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). PGF2α 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 ebopiprant markedly reduces spontaneous and induced uterine contractions in pregnant rats without causing the fetal side effects seen with non-specific prostaglandin inhibitors such as indomethacin.
Ebopiprant (OBE022) was licensed from Merck KGaA, Darmstadt, Germany, in 2015. ObsEva retains worldwide, exclusive, commercial rights.
Nolasiban (previously known as OBE001), is an oral oxytocin receptor antagonist which was licensed from Merck KGaA, Darmstadt, Germany, in 2013. ObsEva retains worldwide, exclusive, commercial rights (ex China).
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.
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, the potential for new indications for any of ObsEva’s product candidates, the timing of enrollment in and data from clinical trials, expectations regarding regulatory and development milestones, including the potential timing of regulatory submissions to the EMA and FDA, the timing of and ObsEva’s ability to obtain and maintain regulatory approvals for its product candidates 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 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, 2019, the Risk Factors disclosed in ObsEva’s Report on Form 6-K filed with the Securities and Exchange Commission (SEC) on November 5, 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.
For further information, please contact:
CEO Office contact
+41 22 552 1550
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
Introducing CorityOne™3.3.2021 19:00:00 CET | Press release
Next-generation unified EHS and Quality platform empowers those who transform the way the world works Toronto, March 03, 2021 (GLOBE NEWSWIRE) -- Cority, the leading global enterprise EHS software provider, today announced a groundbreaking next-generation release of its true SaaS platform. CorityOne builds on a heritage of pragmatic innovation and is designed to help EHS and business leaders thrive beyond today to build stronger, more resilient, connected, and sustainable organizations that deliver on the promise of a better tomorrow. Recently recognized as a Leader in the Green Quadrant EHS Software 2021 by independent analyst firm, Verdantix, CorityOne brings together the most comprehensive Environmental, Health, Safety (EHS), and Quality management functionality to a common platform approach, unifying capabilities from acquired assets, including Enviance, and setting a new standard for the digital transformation of EHS and Quality. “It’s time to think diﬀerently about the future,” s
Bombardier and Aston Martin Announce Intent to Collaborate and Create the Ultimate Convergence of Performance and Style3.3.2021 18:00:00 CET | Press release
Exclusive opportunity for Bombardier business aircraft customers to design their aircraft in collaboration with luxury British automotive manufacturer Initiative complements Bombardier’s established design leadership MONTREAL, March 03, 2021 (GLOBE NEWSWIRE) -- Aston Martin and Bombardier – two iconic brands – have signed a letter of intent to collaborate on custom design services for Bombardier business jets. The collaboration would give customers the opportunity for a truly unique design experience, with the meeting of the top creative minds from the luxury automotive and private jet industries. “Bombardier’s discerning customers have come to expect our products’ signature smooth ride and the company’s no-compromise approach to design, performance and reliability at every level of our portfolio,” said Peter Likoray, Senior Vice President, Sales and Marketing, New Aircraft, Bombardier. “We would be proud to add a new facet to this experience that channels Aston Martin’s distinct aesth
Eurocastle to Release Fourth Quarter 2020 Financial Results on 5 March 20213.3.2021 17:56:51 CET | Press release
Contact: Oak Fund Services (Guernsey) Limited Company Administrator Attn: Mark Woodall Tel: +44 1481 723450 Eurocastle to Release Fourth Quarter 2020 Financial Results on 5 March 2021 Guernsey, 3 March, 2021 – Eurocastle Investment Limited (“Eurocastle” or the “Company”) today announces that it will release its financial results for the twelve months ended 31 December 2020 on Friday, 5 March 2021 before the market opens. ABOUT EUROCASTLE Eurocastle Investment Limited (the “Company” or “Eurocastle”) is a publicly traded closed-ended investment company with investments focused on Italian performing and non-performing loans, Italian loan servicing platforms and other real estate related assets in Italy. On 18 November 2019, the Company announced a plan to realise the majority of its assets with the aim of accelerating the return of value to shareholders. The Company does not currently intend to seek new investments from the proceeds of the realisation but will continue to support its
SEK TENDER OPERATION ANNOUNCEMENT FOR ONWARD LENDING3.3.2021 16:20:00 CET | Press release
Bid date, 2021-03-05Bid Submission Date2021-03-05Bid times10.30-11.00 (CET/CEST) on the Bid dateOffered Amount50 billion SEKMaximum Permitted Bid Volume12.5 billion SEK from an individual bidderSettlement Date2021-03-09Minimum Permitted Bid Volume10 million SEK per bidFinal Repayment Date2025-03-10Maximum Allocation25 per cent of Offered AmountAllocation TimeNot later than 11.30 (CET/CEST) on the Bid dateRepayment Date2022-03-09Option Repayment Date 12023-03-09Option Repayment Date 22024-03-11Interest rateThe Riksbank´s applicable repo rateAdditional interest rate0.10 per centConfirmation of bids to firstname.lastname@example.org Stockholm, 2021-03-03 This is a translation of the special terms and conditions published on www.riksbank.se. In the case of any inconsistency between the English translation and the Swedish language version, the Swedish language version shall prevail. Complete terms and conditions can be retrieved at www.riksbank.se.
Auction details government bonds3.3.2021 16:20:00 CET | Press release
Auction date March 10, 2021 Maturity date Loan ISIN code Coupon Issue volume, SEK million 2023-11-13 1057 SE0004869071 1.50%2,000 2032-06-01 1056 SE0004517290 2.25% 3,000 Settlement date March 12, 2021 Bids have to be entered by 11.00 on March 10, 2021 Bid only through dealers approved by the Swedish National Debt Office For more information, please contact: The funding desk + 46 8 613 4780 FO@riksgalden.se
AERION, NETJETS AND FLIGHTSAFETY INTERNATIONAL TO EXPLORE FUTURE GLOBAL MOBILITY SOLUTIONS3.3.2021 16:03:23 CET | Press release
Aerion® signs expansive Memorandum of Understanding (MOU) with NetJets and FlightSafety International® (FSI) to shape the future of global mobility NetJets and Aerion to explore exclusive partnership for the global mobility platform, Aerion ConnectTM FSI to support Aerion in establishing a new global Supersonic Training Academy NetJets has obtained purchase rights for 20 AS2® supersonic business jets, extending Aerion’s global order backlog to USD $10 billion+ ahead of 2023 production start Reno, NV & Columbus, OH, March 03, 2021 (GLOBE NEWSWIRE) -- Supersonic aircraft company Aerion, the leader in supersonic technology has forged an expansive collaboration with NetJets, the largest private aviation company in the world, and FlightSafety International, the leader in professional aviation training, — both Berkshire Hathaway companies — to shape the future of global mobility. “At Aerion our vision is to build a future where humanity can travel between any two points on our planet within
AT&T and other leading communications companies join the 25GS-PON Multi-Source Agreement (MSA) Group3.3.2021 15:00:00 CET | Press release
The 25G symmetric PON multi-source agreement (25GS-PON MSA) Group is growing rapidly, with the addition of seven new members since it was first announcedAT&T’s commitment to the MSA Group highlights the importance of 25GS-PON to the telecommunications industryTechnology vendors including CommScope, Cortina Access, Feneck, HiLight Semiconductor, Hisense Broadband and Semtech among those fast-tracking 25GS-PON commercialization Industry group brings together major operators along with leading system and component vendors to define and promote next-generation 25GS-PON technology in support of emerging 5G and industrial requirements at cost-effective price targets March 3, 2021 The 25GS-PON MSA Group today announced the addition of seven new member companies including AT&T, CommScope, Cortina Access, Feneck, HiLight Semiconductor, Hisense Broadband and Semtech. These companies, along with the ten founding 25GS-PON MSA members, are enabling a move beyond the limitations of 10 Gb/s next-gene