OXO-001 is a revolutionary fertility drug that has shown promise in making in vitro fertilization (IVF) methods more likely to work. It is the first oral medicine of its kind. The drug was created by the Spanish biotech business Oxolife and works on the womb's lining to help the embryo implant.
Promising Results from Clinical Trials
The new Phase 2 clinical trial, OXOART2, occurred in 28 European sites from September 2021 to January 2023. The study looked at 96 women younger than 40 who were getting donor eggs through IVF or intracytoplasmic sperm injection (ICSI). People were randomly given either OXO-001 or a sugar pill, which they had to take twice a day, starting one menstrual cycle before the egg transfer and continuing for five weeks afterward.
The findings were shown at the 40th annual meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Amsterdam. They showed that people who took OXO-001 had much better pregnancy outcomes.
Ten weeks after embryo transfer, 46.3% of women in the OXO-001 group were still pregnant, while only 35.7% of women in the control group were still pregnant. In absolute terms, this is a 10.6 percentage point rise, a statistically significant and clinically meaningful gain.
The biochemical pregnancy rate in early pregnancy was 75.9% in the OXO-001 group and 52.4% in the control group. Also, the number of live births went up by 6.9 percentage points, with 42.6% of women who took OXO-001 giving birth compared to 35.7% of women who took the placebo.
Oxolife's CEO and CMO, Dr. Agnès Arbat, stressed the importance of the results, saying that a rise of more than five percentage points in current pregnancies is clinically significant. According to her, they saw an increase of more than nine percentage points, which has given patients and scientists new hope.
A New Chance for IVF to Work
The success of OXO-001 is a big step forward in fertility treatments, meeting a critical need for higher success rates in implanting embryos. Even though IVF technology has improved, egg implantation failure is still a big problem. The World Health Organization says that one in six people of childbearing age have trouble getting pregnant. Each year, over three million IVF rounds are done around the world.
As a non-hormonal drug that works directly on the endometrium (the lining of the uterus), OXO-001 is different from other medicines. This new way of doing things could lead to more therapeutic choices in assisted reproduction.
Oxolife's chief scientific officer, Dr. Ignasi Canals, was excited about the study's results. He talked about their excitement and said that the results showed that OXO-001 could be the first treatment to improve the embryo implantation rate. He said it is a non-hormonal drug that works in a new way and affects the uterus directly.
Professor Dr. Karen Sermon, Chair of ESHRE, stressed how important these results might be. Despite ongoing progress in ovarian stimulation, embryo manipulation, and culture, gains in the number of live births in medically assisted reproduction have been small at best. She said that a nearly 7% rise is excellent news for patients and hopes that these results can be confirmed in bigger groups of patients.
The research also found that OXO-001 was well accepted. Headaches, nausea, and stomach problems were mild to moderate and about the same in the OXO-001 and placebo groups. Importantly, data from six months later showed that babies had good developmental results, with no differences between the groups.
The good results of the OXOART2 study give hope to millions of people who are going through fertility treatments. This could change the way IVF is done to improve success rates. The following steps in clinical development will test OXO-001's safety and effectiveness even more. This hopeful treatment will be one step closer to becoming a reality for people with trouble getting pregnant.
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