Salute e Benessere
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
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 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 .
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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].
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/
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