Oxolife has announced positive phase 2 clinical data on its fertility pill OXO-001 at the European Society of Human Reproduction and Embryology (ESHRE) 40th Annual Meeting, which was held in Amsterdam, the Netherlands.

OXO-001 is a ‘first-in-class, non-hormona l drug that acts directly on the endometrium – the inner lining of the uterus – to make it more conducive to embr yo implantation’, according to the company’s press release.

The company has shared data from its proof-of-concept phase 2 double-blinded, randomised controlled trial of the drug, in which it was compared to a placebo dose. A subset of the trial included 96 women up to the age of 40, who all underwent single embr yo transfer using donor eggs. This demonstrated a large and statistically significant improvement in the biochemical pregnancy rate (early detection of pregnancy), with the rate of biochemically confirmed pregnancies among OXO-001 patients being 75.9% compared to only 52.4% for the placebo group.

Agnès Arbat, chief executive officer of Oxolife, commented: “Most rounds of IVF or ICSI still end in failure – many, because a viable embr yo 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. This study was purposefully designed to include only women who used donor eggs, so it could single out the true effect of OXO-001 on the endometrium. However, we believe OXO-001 has the potential to work equally well in those using their own eggs, and we are already planning a pivotal phase 3 clinical trial in this more extensive group to support product registration.”

Dr Karen Sermon, chair of ESHRE, who was not involved in the study, added: “Despite continuous developments in ovarian stimulation, embr yo 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.”