Oxolife's Non-Hormonal Pill Boosts IVF Success Rates, ESHRE Data Shows

Oxolife, a biotechnology firm specializing in female fertility, has announced promising Phase 2 clinical trial results for its innovative fertility drug, OXO-001. During the European Society of Human Reproduction and Embryology (ESHRE) 40th Annual Meeting in Amsterdam, the company shared data demonstrating significant improvements in pregnancy outcomes for women undergoing assisted reproductive technology (ART) treatments.

OXO-001 is a groundbreaking, non-hormonal medication designed to enhance embryo implantation by making the endometrium—the uterus's inner lining—more receptive. This drug addresses a critical issue in fertility treatments like in-vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI), where failure to implant viable embryos often leads to unsuccessful pregnancy attempts.

The Phase 2 trial involved 96 women up to 40 years old, all of whom received donor eggs for single embryo transfer. The trial was double-blinded and randomized, comparing the effects of OXO-001 to a placebo. The results were encouraging: 75.9% of women who took OXO-001 had a biochemically confirmed pregnancy, compared to 52.4% in the placebo group. Clinically confirmed pregnancy rates, ongoing pregnancy rates, and live birth rates also showed marked improvements with OXO-001.

Specifically, the ongoing pregnancy rate at ten weeks post-embryo transfer was 46.3% for OXO-001 users, compared to 35.7% for those on the placebo. The live birth rate was also higher for OXO-001 at 42.6%, compared to 35.7% for the placebo. Although these results were not statistically powered to confirm significance, they provide strong grounds for advancing to a Phase 3 trial.

Agnès Arbat, CEO of Oxolife, emphasized the potential impact of OXO-001: "A simple-to-take pill that materially improves the chance of success would 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." Arbat highlighted the notable improvement in pregnancy rates, which is particularly significant for those struggling with unsuccessful IVF or ICSI attempts.

OXO-001 operates by acting directly on the endometrium, encouraging the embryo to halt its rolling movement, invade the endometrial tissue, and complete implantation. Clinical trials and extensive preclinical testing have shown that the drug is safe, rapidly absorbed, and expelled from the body within 24 hours. Follow-ups on infants born from the trial show normal development, comparable to those in the placebo group.

Professor Dr. Karen Sermon, Chair of ESHRE, praised the results, stating that the nearly seven percentage point increase in live birth rates is excellent news for patients. This drug could revolutionize fertility treatments, offering hope for improved outcomes.

Oxolife is now planning a pivotal Phase 3 trial that will include women using their own eggs. This trial aims to further validate the efficacy of OXO-001 and support its eventual market registration. Additionally, the company is looking into potential partnerships to expedite bringing OXO-001 to patients.

The global infertility market is expanding at a rate of 4.5% annually, driven by factors such as delayed pregnancies, obesity, smoking, and alcohol use. About one in six women of childbearing age faces challenges in conceiving, making the advances in fertility treatments like OXO-001 highly significant. Oxolife is also exploring the drug's potential for treating Polycystic Ovary Syndrome (PCOS), a condition that affects ovulation and fertility.

Overall, the success of OXO-001 in Phase 2 trials marks a significant step forward in fertility treatment, offering hope to millions of women worldwide struggling with infertility.