The biotechnology company Oxolife, based in the Barcelona Science Park, has started an international clinical trial to evaluate the efficacy of its medicinal product OXO-001, a first-in-class treatment that acts specifically on the implantation of the embryo to increase the pregnancy success rate. This is a major breakthrough, since it responds to an unmet medical need that affects millions of women undergoing assisted reproduction around the world, and for which there is no therapeutic option.

Oxolife has been able to initiate this phase II study thanks to a €5 million financing round that it closed in 2020, led by the Inveready fund, together with the Centro para el Desarrollo Tecnológico Industrial (CDTI) and BStartup, among others.

The trial, named OXOART-2, is aimed at demonstrating that OXO-001 improves embryo implantation compared to placebo. The study is being conducted in 24 assisted reproduction clinics in Spain, the Czech Republic and Poland, and aims to include 351 women who will undergo an IVF cycle.

OXO-001 is a hormone-free oral tablet, which has already been shown to be effective in improving embryo implantation in preclinical studies. It has also passed all required pre-clinical safety studies with the quality standards of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The current Phase II study is scheduled for completion in 2023 and, with positive results, Oxolife will conduct a final Phase III trial, with the aim of bringing OXO-001 to market in 2028.

‘The positive results obtained to date make OXO-001 a highly promising potential treatment for improving fertility and pregnancy rates in women undergoing assisted reproduction. We are now entering a second phase clinical trial in which we hope to add more patients every day who want to participate in the study and help us to be pioneers in improving female fertility,’ says Dr Agnès Arbat, CEO and CMO of Oxolife.

‘After certifying the good safety profile of OXO-001, we are now moving forward to demonstrate its efficacy in improving fertility, for which we have 24 reference sites that we would like to thank for their collaboration in the trial,’ says Dr Ignasi Canals, scientific director of Oxolife. ‘OXO-001 is an opportunity, considering that every year more than 3 million cycles of assisted reproductive techniques such as in-vitro fertilisation are carried out around the world, but more than half do not end with a birth, for reasons such as failure of embryo implantation’.

Assisted reproduction centers involved in the trial

A large part of the Oxolife study will take place in Spain, where 13 of the 24 participating hospitals are located, and where at least 50% of the patients are expected to be included. In fact, Spain is the country where more in vitro fertilisation cycles are performed in all of Europe, with assisted reproduction centres with outstanding international experience and reputation.

The Spanish assisted reproduction clinics that are including patients in the Oxolife trial are located in the cities of Madrid (IVI Madrid, Hospital Universitario Quirónsalud Madrid, GINEFIV Madrid, Instituto Bernabéu Madrid), Barcelona (IVI Barcelona, Hospital Universitario Dexeus, Hospital Universitario Quirónsalud Barcelona), Valencia (IVI Valencia), Seville (Ginemed Sevilla), Zaragoza (IVI Zaragoza), Palma (IVI Mallorca), Bilbao (IVI Bilbao) and Alicante (Instituto Bernabéu Alicante).

The participating centers from Czech Republic are: IVF CUBE, Sanatorium PRONATAL, ISCARE centrum asistované reprodukce, Klinika reprodukční medicíny a gynekologie, Fertimed s.r.o., Pronatal NORD and UNICA Prague s.r.o.  From Poland, are involved in the trial: VitroLive Sp. z o.o, Provita Sp. z o.o, Przychodnia Lekarska nOvum, Katarzyna Kozioł, Piotr Lewandowski spółka jawna and OVIklinika.

The women participating in the study will be divided into three treatment groups: one with placebo, and the other two with doses of OXO-001. They will receive one oral tablet daily over a period of two to three months. The results of the trial are expected to show an improvement in pregnancy and birth rates in women treated with OXO-001 compared to the placebo group, and to determine whether one of the two doses of the drug tested is associated with better efficacy than the other. Furthermore, the study also includes a follow-up of the mother and the newborn up to six months after birth.