ReproNovo Readies Assets for Phase 2 Trials

ReproNovo made its debut appearance at BIO-Europe. This new reproductive medicine company is moving quickly. Founded just three years ago, it has already built a pipeline comprising two assets, which are in development across three disease areas.

RPN-001 will enter a phase 2 trial in male infertility, while RPN-002 will enter two phase 2 trials - to aid embryo implantation in women undergoing in vitro fertilization (IVF) and to treat symptoms of adenomyosis.

Each molecule already has an extensive clinical history. RPN-001, an aromatase inhibitor also called leflutrozole, originated at Novartis, which licensed the candidate drug to Mereo BioPharma. Novartis completed phase 1 and phase 2a studies, while Mereo conducted two phase 2b trials showing that the compound normalised serum testosterone levels in men with hypogonadism (low serum testosterone).

ReproNovo has full rights to RPN-001 across all indications. It is not positioning RPN-001 as a testosterone replacement therapy. It will instead focus on treating infertile men with low serum testosterone in order to improve semen quality and thereby the probability of pregnancy. Although several aromatase inhibitors are approved as adjuvant drugs for treating breast cancer in women, none have been developed for the treatment of male infertility.

RPN-002, also called nolasiban, is an oxytocin receptor antagonist. ReproNovo acquired the asset from ObsEva, which had conducted several clinical trials. This candidate drug has the potential to improve pregnancy and live birth rates in women undergoing IVF. “We believe we understand how we can achieve success in our clinical studies,” Jean Marie Duvall, co-founder and CEO of ReproNovo said. Although the company is not publicly disclosing further information at this point, it has designed a clinical programme to incorporate these insights.

The molecule has not been tested previously in adenomyosis, a uterine condition associated with painful symptoms, such as severe menstrual cramps and heavy menstrual periods. The disease is a significant cause of female infertility and poor obstetric outcomes. There are no therapies available for those with the condition.

Duvall, a serial entrepreneur and seasoned pharma executive, co-founded the firm with Dr. Joan-Carles Arce, its chief scientific officer and chief medical officer, and chief financial officer BingMei Hao. It has assembled a team with deep experience in the reproductive medicine space. It is headquartered in Lausanne, Switzerland, although its main development team is located in Copenhagen. Additional development sites are based in the United States and Barcelona. The company aims to complete its Series A transaction in the coming months.