New research has demonstrated the effectiveness of a first-in-class oral, non-hormonal drug in increasing embryo implantation, pregnancy and live birth rates among infertile women who are undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) [1]. The findings, presented today at the ESHRE 40th Annual Meeting in Amsterdam, represent a significant step toward the first therapeutic tool to increase embryo implantation and live birth rate success.
Worldwide, one in six people of reproductive age experience infertility in their lifetime [2]. Over 3 million IVF cycles are performed annually [3] and yet, despite advancing IVF technologies, embryo implantation failure remains a significant challenge [4].
In response to this unmet need, researchers have unveiled the promising findings of their Phase 2 clinical trial, OXOART2. This randomised, double-blind, placebo-controlled trial conducted across 28 centres in Europe evaluated OXO-001, a first-in-class oral drug that acts directly on the endometrium (inner lining of the uterus) to improve embryo implantation and pregnancy rates.
The OXOLIFE exploratory subset study analysed 96 women aged up to 40 years old who underwent a single embryo transfer, 42 receiving placebo and 54 receiving a daily dose of OXO-001. Treatment began one menstrual cycle before the embryo transfer cycle and continued until five weeks after the transfer.
Statistically significant improvements were observed in biochemical pregnancy rates – an early detection of pregnancy – with rates of 75.9% in the OXO-001 group compared to 52.4% in the placebo group. Clinically relevant improvements were also seen in clinical pregnancy rates (foetal heartbeat 5 weeks after embryo transfer), and in ongoing pregnancy rates (10 weeks post-embryo transfer), being a +14.3 absolute increase (50.0% for OXO-001 vs. 35.7% for placebo) and a +10.6 absolute increase (46.3% for OXO-001 vs 35.7% for placebo) respectively.
Most importantly, there was an absolute increase of +6.9 in live birth rates (42.6% for OXO-001 vs. 35.7% for placebo).
Dr. Agnès Arbat, OXOLIFE’s CEO and CMO, comments, “From scientific societies, key opinion leaders, clinicians and patients, we know that an absolute increase of more than 5 percentage points in ongoing pregnancy is considered clinically meaningful. We observed an increase higher than +9, giving renewed hope to patients and the scientific community. We look forward to advancing this promising treatment through the next phases of clinical development.”
The occurrence of side effects was similar in both groups. The most common side effects were headaches, nausea, vomiting, gastrointestinal issues, and dizziness, most of which were mild to moderate. More importantly, in the six-month follow-up, the babies indicated good development with no differences with placebo. Overall, OXO-001 was well tolerated, with high rates of compliance.
Dr. Ignasi Canals, CSO of OXOLIFE adds, “We are thrilled with the results of this trial, which highlight OXO-001’s potential to become the first therapeutic treatment to increase embryo implantation success, with a non-hormonal drug using a new mechanism of action, acting directly on the endometrium.”
Professor Dr Karen Sermon, Chair of ESHRE, explains “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 7% is very good news for our patients, and hopefully this can be confirmed in larger patient groups.”
The study abstract will be published today in Human Reproduction, one of the world’s leading reproductive medicine journals.
ENDS
Notes to editors:
A reference to the ESHRE Annual Meeting must be included in all coverage and/or articles associated with this study.
For more information or to arrange an expert interview, please contact the ESHRE Press Office at: press@eshre.eu
About OXOLIFE and study author:
Dr. Arbat is the founder, Chief Executive Officer and Chief Medical Officer of OXOLIFE S.L.
Dr Arbat graduated as Medical Doctor from UAB and Clinical Pharmacologist specialist. She has 14 years of experience in pharmaceutical industry, of which the last 10 years at Bayer, leading WH and Cardiovascular Therapeutic Area Medical team. Dr Arbat has 10 indexed international papers, more than 30 communications at international congresses, more than 20 clinical trials, and more than 10 products or new indications launched.
Oxolife is a specialist biotech focused on women’s fertility. Its lead compound OXO-001 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. Oxolife is currently fundraising to accelerate the progress of OXO-001, its lead programme, through the clinic.
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.
Website: https://www.eshre.eu/
About Human Reproduction
Human Reproduction is a monthly journal of ESHRE and is one of the top three journals in the world in the field of reproductive biology, obstetrics and gynaecology. It is published by Oxford Journals, a division of Oxford University Press.
References:
- Arbat, A. et al. (2024). Efficacy results from the phase II randomized clinical trial: OXO-001 in infertile women undergoing egg donation IVF/ICSI. Human Reproduction. Available at: https://academic.oup.com/humrep/issue/39/Supplement_1
- World Health Organization. (2024). Infertility. Retrieved from https://www.who.int/news-room/fact-sheets/detail/infertility#:~:text=Infertility%20affects%20millions%20of%20people,experience%20infertility%20in%20their%20lifetime
- European Society of Human Reproduction and Embryology. (2022). Factsheet on ART. Retrieved from https://www.eshre.eu/Europe/Factsheets-and-infographics
- 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