Major 2018 Accomplishments Driven by Positive Clinical Trial Results
-Significant increase in rates of pregnancy and live birth (up to 35% increase in Day 5 ET) in Phase 3 IMPLANT 2 trial of nolasiban in IVF procedures
-Significant reduction in pain symptoms (3/4 of patients meeting responder criteria) and BMD safety as expected in Phase 2b EDELWEISS trial of linzagolix in endometriosis related pelvic pain
-Positive initial PK-PD and safety results in the open label Part A of Phase 2a PROLONG trial of OBE022 in acute pre-term labor
2019: A Transformational Year with Several Expected Key Milestones
-As many as six Phase 3 trials ongoing, with linzagolix endometriosis and fibroid programs and confirmatory IMPLANT4 EU trial of nolasiban in IVF underway
-Primary endpoint results from IMPLANT4 trial of nolasiban expected by Q4:19 and MAA regulatory filing planned prior to the end of 2019
-Additional FDA feedback on nolasiban development expected in 2019, which may lead to commencement of the US Phase 3 program in H2:19
-Phase 3 primary endpoint results from PRIMROSE trial program of linzagolix in uterine fibroids starting in Q4:19
“2018 was a year of tremendous pipeline advancement with successful clinical data readouts that have positioned
November 2018, ObsEvaannounced the initiation of the Phase 3 IMPLANT4 trial of the oxytocin receptor antagonist nolasiban in IVF. IMPLANT4 is planning to enroll approximately 820 patients undergoing a Day 5 single embryo transfer (SET) at approximately 50 clinical sites in 10 countries primarily in Europe(n=41), Canada(n=4) and Russia(n=4).
December 2018, patient recruitment was completed in the Phase 3 PRIMROSE 2 trial of the oral GnRH receptor antagonist linzagolix for the treatment of uterine fibroids. Along with the PRIMROSE 1 trial in the U.S., these trials are targeting enrollment of approximately 1,000 women and are designed to assess the effect of the linzagolix treatment on heavy menstrual bleeding (HMB) associated with uterine fibroids. The efficacy and safety of two linzagolix doses being studied are 100mg without ABT and 200mg with ABT.
- Also during the quarter,
ObsEvacompleted a successful end-of-Phase 2 meeting with the FDAto review the Phase 3 clinical trial program for linzagolix in endometriosis, which is commencing this quarter. The EDELWEISS 2 and 3 trials are expected to enroll approximately 900 patients in total with endometriosis associated pain, comparing two, once-daily, dosing regimens of linzagolix to placebo; 75mg without ABT, and 200mg with ABT.
- In early 2019,
ObsEvaannounced the completion of the open label Part A of the PROLONG Phase 2a trial of the oral prostaglandin F2 alpha receptor antagonist OBE022, for the treatment of pre-term labor in pregnant women between 24 and 34 weeks of gestation. The randomized, double-blinded, placebo-controlled Part B of the trial is presently enrolling patients after observing 8 of 9 patients successfully completing the 7-day dosing period without delivering a baby, as well as a positive pharmacokinetic (PK) and safety data.
- In the second quarter of 2019, results for the final prospectively designed endpoint are expected from the IMPLANT2 trial of nolasiban, which is the 6-month pediatric safety follow-up.
- In the first half of 2019, the Week 48 (6-month post treatment follow-up) and the Week 52 (treatment extension up to 12 months) results in the EDELWEISS phase 2b trial.
- In the second quarter of 2019,
ObsEvaexpects to announce completion of patient recruitment in the IMPLANT 4 trial of nolasiban with expected primary endpoint, 10-week ongoing pregnancy results expected in the fourth quarter of 2019. Assuming confirmatory results, a European Marketing Authorization Application (MAA) regulatory submission is planned for late 2019.
- For U.S. nolasiban development, additional
FDAfeedback on trial design is expected in the second quarter of 2019, which may lead to commencement of the Phase 3 program in the second half of 2019.
- Six-month primary endpoint data from the PRIMROSE 2 trial of linzagolix for the treatment of uterine fibroids is expected in the fourth quarter of 2019, and recruitment completion for the PRIMROSE 1 trial is now expected in the second quarter of 2019 with primary endpoint data anticipated in early 2020. Accordingly, an NDA for linzagolix in uterine fibroids remains targeted for 2020.
- Part B of the Phase 2a PROLONG clinical trial of OBE022 in acute pre-term labor is presently ongoing, with initial interim analysis of the primary endpoint for the first 30 patients expected by H1:19.
Full Year 2018 Financial Results
Net loss for the fourth quarter and full year of 2018 was
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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
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