Ovoca Bio announced that it has initiated a Phase 2 study of its BP-101 intranasal synthetic peptide for the treatment of hypoactive sexual desire disorder (HSDD). The dose ranging study, which will take place in Australia and New Zealand, is expected to enroll 476 premenopausal women who are experiencing distress due to low libido and will evaluate the effects of three dose levels of the nasal spray and placebo over four weeks.
According to Ovoca, a Phase 3 trial of BP-101 used to support a 2019 marketing application for BP-101 in Russia “demonstrated a strong efficacy profile in patients with HSDD.” The company recently announced that it had resubmitted that application several months after the Russian Ministry of Health rejected it due to issues with the CMC and labelling sections of the dossier.
Ovoca Bio CEO Kirill Golovanov said, “We are delighted that the first patient has been enrolled in this Phase 2 study as we continue towards our goal of establishing the value of BP-101 as a potential treatment for patients around the world suffering from HSDD. We hope that this study of BP-101, the first to be conducted outside of Russia, will pave the way for the international development of BP-101 in the US and EU. We look forward to providing further updates in due course.”
Monash University Professor Susan Davis, the study’s principal investigator, commented, “HSDD can have a profound impact on women’s lives and has been identified by the US FDA as an area of high priority and significant unmet medical need. We welcome the opportunity to offer patients access to this study and are eager to gather further data to help assess the potential of BP-101 as a future treatment for this condition.”
Read the Ovoca Bio press release.
