New research has shown the effectiveness of a first-in-class oral, non-hormonal drug in increasing embryo implantation, pregnancy and live birth rates in infertile women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The findings were presented today at ESHRE 40u The annual meeting in Amsterdam represents an important step towards the first therapeutic tool to increase the success of embryo implantation and the rate of live births.
Worldwide, one in six people of reproductive age experience infertility in their lifetime. Over 3 million IVF cycles are performed annually and yet, despite advanced IVF technologies, embryo implantation failure remains a significant challenge.
In response to this unmet need, researchers have revealed the promising findings of the Phase 2 clinical trial, OXOART2. This randomized, double-blind, placebo-controlled trial conducted at 28 centers 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 of pregnancy rates.
The OXOLIFE study’s exploratory subgroup analyzed 96 women up to 40 years of age who underwent a single embryo transfer, 42 received placebo and 54 received 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 seen 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 (fetal heart rate 5 weeks after transfer) and ongoing pregnancy rates (10 weeks after transfer), which is an absolute increase of +14.3 (50.0% for OXO- 001 vs. 35.7% for placebo) and +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).
Doctors and patients, we know that an absolute increase of more than 5 percentage points in ongoing pregnancy is considered clinically significant. We observed an increase higher than +9, giving renewed hope to patients and the scientific community. We look forward to advancing this promising treatment into the next phases of clinical development.”
Dr. Agnès Arbat, CEO and CMO of OXOLIFE
The incidence of adverse events was similar in both groups. The most common side effects were headaches, nausea, vomiting, gastrointestinal problems and dizziness, most of which were mild to moderate. Most importantly, at the six-month follow-up, the babies showed good growth with no differences with the placebo. Overall, OXO-001 was well tolerated, with high compliance rates.
Dr. Ignasi Canals, CSO of OXOLIFE adds: “We are excited by the results of this trial, which highlight the potential of OXO-001 to become the first therapeutic to increase embryo implantation success, with a non-hormonal drug that uses a new mechanism of action, acting directly on the endometrium”.
Professor Dr Karen Sermon, President of ESHRE, explains “Despite ongoing advances in ovarian stimulation, embryo manipulation and culture, the improvement in live birth rates in medically assisted reproduction has been incremental at best. A jump of almost 7% is very good news for our patients, and we hope this can be confirmed in larger groups of patients.”
The abstract of the study will be published today in Human Reproductionone of the leading reproductive medicine journals in the world.
