Dive Brief:
- Swiss biotech ObsEva SA on Monday reported positive topline results from the Phase 3 IMPLANT2 study of its oral oxytocin receptor antagonist nolasiban.
- Treatment with the drug led to a statistically significant improvement in the rate of ongoing pregnancy following in vitro fertilization (IVF), boosting the rate by an absolute increase of 7.1% at 10 weeks compared to placebo.
- IMPLANT2 was conducted in 778 patients across 41 clinical trial sites in nine European countries. Patients received a single 900 mg dose of nolasiban or placebo on the day of embryo transfer.
Dive Insight:
With many women waiting longer to have children, fertility procedures are on the rise. According to the company, nearly 10% of reproductive aged couples undergo IVF to get pregnant.
ObsEva is looking to capitalize on that market and increase the chances of the procedure working. The global infertility drug market is expected to grow by a compounded annual growth rated of 5% from 2018 to 2022, according to a market research report from Technavio.
The biotech's experimental drug would have an advantage over competition due to its oral delivery. The drug atosiban, already approved as a treatment to prevent pre-term labor, has shown similar efficacy in studies but is given intravenously.
Patients in the study received the drug and embryo transfer either three days or five days after the egg was removed from a woman's ovary. The data showed those given the drug and embryo transfer at day five had an even higher absolute increase at 10 weeks of 11.2%. In contrast, the day three group did not have a statistically significant increase. Safety results for the treatment arm were similar to that of the placebo group.
Follow-up data from the study will include rates of live births, as well as 28-day neonatal safety and six-month infant follow-up. Those results are expected at the end of 2018 and in mid-2019, respectively.
A previous study, called IMPLANT1, showed an absolute increase of about 16% between the two groups, but had slightly different enrollment criteria.
Based on the results of the two studies, ObsEva plans to talk with regulators about a path forward. The company said it will likely have to conduct a further Phase 3 trial for Food and Drug Administration approval.
Jefferies analyst Biren Amin projects the drug will reach peak sales of $58 million in the EU by 2030, with all U.S. sales considered upside.