ObsEva posted encouraging topline data from a phase 3 trial of nolasiban, a drug designed to improve the pregnancy rate of in vitro fertilization procedures. The oxytocin receptor antagonist met its primary endpoint—ongoing pregnancy—and was well tolerated.
The randomized, double-blind, placebo-controlled trial, dubbed IMPLANT2, involved 778 patients undergoing IVF treatment, also known as intracytoplasmic sperm injection (ICSI), due to infertility, the company said in a statement. Patients received one 900 mg dose of nolasiban or placebo four hours before undergoing embryo transfer.
The primary endpoint, ongoing pregnancy, was measured by ultrasound at the 10-week mark. There was an “absolute increase” in ongoing pregnancy rate of 7.1%, with a rate of 35.6% for the patients receiving nolasiban compared to 28.5% for the placebo group.
Not only were the data statistically significant, “but the magnitude of which we believe represents a highly clinically meaningful improvement for the women undergoing IVF/ICSI procedures” said ObsEva CEO Ernest Loumaye, in the statement. “We believe IMPLANT2 results potentially represent one of the most important innovations in the practice of IVF/ICSI since the emergence of recombinant FSH more than 20 years ago."
The Geneva-based biotech expects to report follow-up data, such as live birth rate and 28-day neonatal safety, in the fourth quarter and expects six-month infant data to read out in 2019. Beyond that, ObsEva will determine its clinical and regulatory timelines after consulting with U.S. and European regulators.
Things look to be on an upswing for ObsEva. The company teed up for an $87 million IPO last year, hoping to sell close to 6.5 million shares for between $14 and $16 apiece, eventually raising just under $97 million at the end of January.
Born out of a Merck KGaA restructuring in 2013, ObsEva launched with $34.5 million. After picking up the ex-Asia rights to Kissei Pharmaceutical’s GnRH receptor antagonist, KLH-2109, the biotech reeled in another $60 million in its series B. KLH-2109, now known as OBE2109, is in phase 2 for endometriosis and phase 3 for uterine fibroids.