A pill for infertility: Oxolife's non-hormonal oral drug raises embryo implantation rate, pregnancy rates and live birth rate in women undergoing IVF and ICSI, data being presented at ESHRE shows

• Oxolife's OXO-001 is a safe, first-in-class drug designed to improve the odds of an embryo embedding by making the endometrium more conducive to implantation
• Ongoing pregnancy rate was 10.6 percentage points higher in women who received OXO-001 than in those who received a placebo (46.3% for OXO-001 vs. 35.7% for placebo)
• Live birth rate was 6.9 percentage points higher (42.6% vs for OXO-001 vs. 35.7% for placebo)
• Results – from proof-of-concept Phase 2 double-blinded, randomised controlled trial in women up to 40 years of age who used donor eggs – to be published in Human Reproduction
• Oxolife plans pivotal Phase 3 study – to include women using own eggs

BARCELONA, Spain, July 8, 2024 /PRNewswire/ -- Oxolife, the female fertility biotech focused on enhancing embryo implantation in women undergoing assisted reproductive technology (ART) fertility treatment, today presents successful phase 2 clinical data on its fertility pill OXO-001 at the European Society of Human Reproduction and Embryology (ESHRE) 40th Annual Meeting held in Amsterdam.

OXO-001 is a first-in-class, non-hormonal drug that acts directly on the endometrium – the inner lining of the uterus – to make it more conducive to embryo implantation. Failure of viable embryos to implant is a major reason why so many rounds of in-vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) do not result in pregnancy, and consequently a major cause of heartache among those trying for a baby. Taken twice daily, starting one menstrual cycle before embryo transfer and then for five weeks after transfer, OXO-001 is designed to reduce that distressing possibility.

Today, Oxolife is presenting highly promising new data at ESHRE from its proof-of-concept Phase 2 double-blinded, randomised controlled trial of OXO-001, in which it was tested against a placebo pill.

An exploratory subset analysing 96 women up to 40 years of age, who all underwent single embryo transfer using donor eggs, found OXO-001 resulted in a large and statistically significant improvement in the biochemical pregnancy rate (early detection of pregnancy). While 52.4% of those who received the placebo (22 of 42) had a biochemically confirmed pregnancy, among those who received OXO-001 the rate was 75.9% (41 of 54).

There were also clinically meaningful improvements in:

• the clinically confirmed pregnancy rate (fetal heartbeat five weeks after embryo transfer) – 50.0% for OXO-001 vs. 35.7% for placebo;
• the ongoing pregnancy rate (10 weeks post-embryo transfer) – 46.3% vs. 35.7%;
• the live birth rate – 42.6% for OXO-001 vs. 35.7% for placebo.

The Phase 2 trial was not powered to confirm that the differences for these outcomes were statistically significant. However, the data generated strongly supports advancement to Phase 3 confirmatory trial.  Results of the Phase 2 trial are due to be published soon in the highly-regarded journal Human Reproduction.

Agnès Arbat, Chief Executive Officer, Oxolife, said: "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. 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."

Professor Dr Karen Sermon, Chair of ESHRE, who was not involved in the study, 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."

OXO-001 works directly on the endometrium to encourage the embryo to stop rolling, to invade endometrial tissue, and to complete implantation. Extensive preclinical testing, plus clinical testing in 300 women to date, has shown it has an excellent safety profile. It is rapidly absorbed and expelled by the woman's body within 24 hours after administration. In follow-up of babies six months after birth, all demonstrated normal development with no differences compared to placebo.

About one in six women of childbearing age has trouble conceiving[1], while use of fertility treatment is increasing worldwide as couples delay childbearing. Latest figures compiled by ESHRE[2] indicate around four million ART cycles are now performed globally each year, resulting in about one million babies. However, recurrent embryo implantation failure remains a significant challenge[3].

About Oxolife

Oxolife is a specialist biotech focused on female fertility. Its lead compound is an easy to administer, non-hormonal, oral pill that addresses two indications; its lead programme is embryo implantation, a major factor in improving pregnancy success rates; a secondary indication is Polycystic Ovary Syndrome ("PCOS"), where it recovers ovulation and fertility. Its lead indication in embryo implantation has completed phase 2 studies, while its PCOS indication is on track for IND/ CTA application in H1 2025. With the global infertility market growing at 4.5% a year, due to later pregnancies, obesity, smoking and alcohol, 76m women a year are affected, with an expected market value of $45.4bn in 2029. Oxolife is currently fundraising to accelerate the progress of OXO-001, its lead programme, through the clinic and is also exploring potential partnerships to bring the benefits of OXO-001 to patients as rapidly as possible. https://oxolife.com/ 

About the European Society of Human Reproduction and Embryology

The main aim of ESHRE is to promote interest in infertility care and to aim for a holistic understanding of reproductive biology and medicine. ESHRE collaborates world-wide and advocates universal improvements in scientific research, encourages and evaluates new developments in the field, and fosters harmonisation in clinical practice. It also provides guidance to enhance effectiveness, safety and quality assurance in clinical and laboratory procedures, psychosocial care, and promotes ethical practice. ESHRE also fosters prevention of infertility and related educational programmes and promotes reproductive rights regardless of the individual's background. ESHRE's activities include teaching, training, professional accreditations, mentoring and career planning for junior professionals, as well as developing and maintaining data registries. It also facilitates and disseminates research in human reproduction and embryology to the general public, scientists, clinicians, allied personnel, and patient associations. https://www.eshre.eu 

[1] https://www.cdc.gov/nchs/fastats/infertility.htm 

[2] ESHRE ART fact sheet 10, November 2023

[3] Cimadomo, D., Craciunas, L., Vermeulen, N., Vomstein, K., & Toth, B. (2020). Definition, diagnostic and therapeutic options in recurrent implantation failure: An international survey of clinicians and embryologists. Human Reproduction, 36(2), 305–317. https://doi.org/10.1093/humrep/deaa317