2019 Phase 3 Data Readouts on track for nolasiban in IVF and linzagolix in uterine fibroids;
MAA submission for nolasiban IVF therapy targeted by year-end
Nolasiban to improve IVF outcomes
ObsEvacontinued enrolling patients in IMPLANT 4, ObsEva’s confirmatory Phase 3 trial for the oxytocin receptor antagonist nolasiban in IVF. Approximately 820 patients who are undergoing a Day 5 single embryo transfer will be enrolled at approximately 40 sites primarily in Europe. ObsEvareported final follow-up safety data from the nolasiban IMPLANT 2 trial. The results showed no difference from placebo in the developmental health of infants at six months post-birth, as measured by the About Ages and Stages Questionaire-3 (ASQ-3), a broadly validated assessment of infant development.
Linzagolix for the treatment of endometriosis associated pain and heavy menstrual bleeding due to uterine fibroids
ObsEvareported positive long-term data from the Phase 2b EDELWEISS trial of linzagolix in endometriosis. Some patients were treated for 52 weeks in the extension study and others were followed for six months off treatment after the initial six-month treatment period. The results were consistent with prior data, showing durable efficacy as well as favorable bone mineral density impact within expected ranges for partial and full suppression of estrogen. ObsEvamade strong enrollment progress in PRIMROSE 1, the Company’s U.S. Phase 3 trial for linzagolix in the treatment of uterine fibroids. The PRIMROSE 1 and PRIMROSE 2 trials are targeting enrollment of approximately 1,000 women with heavy menstrual bleeding associated with uterine fibroids. The efficacy and safety of two doses of linzagolix are being studied, including 100mg without low dose hormonal add-back therapy (ABT) and 200mg with ABT.
OBE022 for the treatment of preterm labor
ObsEvaannounced encouraging Part A results leading to the initiation of Part B of PROLONG, a proof-of-concept Phase 2a trial of the oral prostaglandin F2 alpha receptor antagonist OBE022 for the treatment of preterm labor. Part A results showed that OBE022 was well tolerated by mothers and their fetuses and supported prior favorable pharmacokinetic analysis. Eight of nine patients achieved the treatment goal of seven-days without delivering a baby.
- Ongoing part B is the multicenter, randomized, double-blind, placebo-controlled portion of the trial that will enroll up to 120 patients with preterm labor at a gestational age of between 24 and 34 weeks.
“We are thrilled with our progress this past quarter as we advanced all three of our Phase 3 clinical programs, and have initiated two Phase 3 trials for endometriosis this year. 2019 is a transformational year for us as we work toward the MAA filing of nolasiban later this year. We are excited about developing our commercial capabilities in anticipation of a planned European launch in 2021,” said Ernest Loumaye, co-founder and Chief Executive Officer of
- In the second quarter of 2019,
ObsEvaexpects to complete patient recruitment in the IMPLANT 4 trial of nolasiban, and to report primary endpoint results (10-week ongoing pregnancy) in the fourth quarter of 2019.
- Assuming positive IMPLANT 4 results, the Company plans to submit a European Marketing Authorization Application (MAA) in late 2019.
- In the second quarter of 2019, the Company anticipates additional
FDAfeedback on the U.S. trial design for nolasiban in IVF, and targets U.S. Phase 3 development initiation in the second half of 2019.
- In the second quarter of 2019,
ObsEvaexpects to complete recruitment in the PRIMROSE 1 trial of linzagolix for the treatment of uterine fibroids, and to report 6-month primary endpoint data in the first quarter of 2020.
- In the fourth quarter of 2019, the Company expects to report six-month primary endpoint data from the PRIMROSE 2 trial of linzagolix for the treatment of uterine fibroids.
- In the second quarter of 2019, the Company expects to enroll patients in the Phase 3 EDELWEISS 2 and EDELWEISS 3 trials for the treatment of endometriosis-associated pain.
- In the second quarter of 2019,
ObsEvaanticipates an initial interim efficacy analysis of the first 30 patients from Part B of the Phase 2a PROLONG clinical trial of OBE022 in acute preterm labor.
First Quarter 2019 Financial Results
Net loss for the first quarter of 2019 was
To access the financial reports section of the Company’s website, please click [here].
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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Consolidated Statement of Comprehensive Loss
|(in USD ’000, except share and per share data)||Three-month period
ended March 31,
|Operating income other than revenue||5||5|
|Research and development expenses||(20,140||)||(16,342||)|
|General and administrative expenses||(5,255||)||(3,649||)|
|Total operating expenses||(25,395||)||(19,991||)|
|NET LOSS BEFORE TAX||(25,672||)||(19,831||)|
|Income tax (expense) / benefit||(7||)||25|
|NET LOSS FOR THE PERIOD||(25,679||)||(19,806||)|
|Net loss per share|
|Weighted Average Number of Shares Outstanding||43,488,440||36,389,578|
Consolidated Balance Sheet
|(in USD ’000)||March 31,
|Cash and cash equivalents||117,321||138,640|
|Total current assets||123,852||145,240|
|Furniture, fixtures and equipment||297||319|
|Other long-term assets||273||273|
|Total non-current assets||24,683||22,200|
|LIABILITIES AND SHAREHOLDERS’ EQUITY|
|Current tax liability||1||—|
|Other payables and current liabilities||3,630||2,766|
|Current lease liabilities||580||—|
|Total current liabilities||18,393||16,929|
|Non-current lease liabilities||1,967||—|
|Other long-term liabilities||—||48|
|Total non-current liabilities||5,481||3,595|
|Total shareholders’ equity||124,661||146,916|
|Total liabilities and shareholders’ equity||148,535||167,440|
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