Oxolife, a biotech company specialising in female fertility, has presented the results of a promising Phase II clinical study centring around the efficacy of its lead asset, OXO-001.
The data was first presented at the European Society of Human Reproduction and Embryology (ESHRE), and detailed the positive effects of the non-hormonal drug.
What is OXO-001?
OXO-001, a first-in-class drug with the ability to directly interact with the endometrium, assists in enhancing its habitability — potentially increasing the chance of successful pregnancies in those undergoing fertility treatments such as in-vitro fertilisation (IVF) and intracytoplasmic sperm injection (ISCI).
A significant challenge in the IVF process is getting viable embryos to implant into the uterus.
Therefore, modulating the properties of the endometrial lining to be more conducive to a successful pregnancy could be highly successful solution to this issue, according to Oxolife.
Phase II trial shows promising results
In trial participants given OXO-001 twice daily — beginning one menstrual cycle before embryo transfer and then subsequently for five weeks after transfer — the drug exhibited a 75.9% pregnancy rate.
OXO-001 also exhibited improvements in:
- Clinically confirmed pregnancy rate
- Ongoing pregnancy rate 10 weeks post-embryo transfer
- Live birth rate (42.6% of participants given OXO-001)
CEO of Oxolife, Agnès Arbat, said: "Most rounds of IVF or ICSI still end in failure, which is mostly due to the inability of a viable embryo to 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 II 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 III clinical trial in this more extensive group to support product registration.”
