Oxolife, a biotech company specializing in female fertility, has announced promising results from a Phase 2 clinical trial of its non-hormonal fertility pill, OXO-001, at the European Society of Human Reproduction and Embryology (ESHRE) 40th Annual Meeting in Amsterdam. The data indicates that OXO-001 significantly improves embryo implantation, pregnancy, and live birth rates in women undergoing in-vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI).
OXO-001, is an oral, non-hormonal pill with the goal to improve embryo implantation and address Polycystic Ovary Syndrome (PCOS). It is designed to make the endometrium, the inner lining of the uterus, more conducive to embryo implantation. In a double-blinded, randomized controlled trial involving 96 women up to 40 years of age who used donor eggs, OXO-001 showed a notable improvement in various fertility metrics.
The study found that the ongoing pregnancy rate was 10.6 percentage points higher in the group receiving OXO-001 compared to the placebo group (46.3% vs. 35.7%). Similarly, the live birth rate was 6.9 percentage points higher for OXO-001 recipients (42.6% vs. 35.7%).
Chief Executive Officer of Oxolife, Agnès Arbat, emphasized the potential impact of these findings, stating: “Most rounds of IVF or ICSI still end in failure – many, because a viable embryo does not implant. A simple-to-take pill that materially improves the chance of success would therefore be of huge benefit to those who want a baby. This proof-of-concept phase 2 study shows that hope is now a step closer. Physicians and patients tell us that they consider a five percentage-point improvement in the ongoing pregnancy rate after IVF/ICSI to be clinically meaningful, so to achieve double that is amazing.”
Professor Dr. Karen Sermon, Chair of ESHRE, commented: “Despite continuous developments in ovarian stimulation, embryo manipulation, and culture, improving live birth rates in medically assisted reproduction has been incremental at best. A jump of nearly seven percentage points is very good news for our patients, and hopefully, this can be confirmed in larger patient groups.”
The Phase 2 trial was not powered to confirm statistical significance for all outcomes, but the data strongly supports moving forward with a Phase 3 confirmatory trial, which will include women using their own eggs. The results of the Phase 2 trial are expected to be published in the journal Human Reproduction.
OXO-001 is taken twice daily, starting one menstrual cycle before embryo transfer and continuing for five weeks after transfer. The drug has shown an excellent safety profile, with no significant differences in the development of babies compared to the placebo group.
