Ovoca Bio enrols participants in women's sexual drug trial

Women’s health-focussed biopharmaceutical company Ovoca Bio announced the successful completion of participant enrollment in a phase 2 dose-ranging study assessing ‘orenetide’ on Friday.

The AIM-traded firm described orenetide as a novel treatment for premenopausal women with hypoactive sexual desire disorder (HSDD), which is a condition characterised by a “distressing” lack or loss of sexual desire.

It said that, despite a “challenging” global environment due to Covid-19 restrictions, it successfully completed the enrollment in line with its previously-announced schedule.

The phase 2 dose-ranging study was being conducted in Australia and New Zealand, and would investigate orenetide administered daily at a range of doses, evaluating the effect of the drug on lack or loss of sexual desire experienced by participants.

A total of 667 women had been screened in the double-blind placebo-controlled study, to allow up to 462 participants to be treated across 13 sites.

The Ovoca management team said it currently expected all enrolled participants would complete the study in the next four months, allowing the assessment of results in the first quarter of 2023.

It said the co-primary objectives of the study were to evaluate the effect of three different doses of Orenetide and placebo, on sexual desire as measured by the female sexual function index desire domain, as well as the degree to which a participant was bothered by low sexual desire as measured by the female sexual distress scale.

The change in those endpoints would be assessed between a four-week baseline period and after four weeks of daily dosing.

All study participants were female, and had a diagnosis of acquired, generalised HSDD.

Orenetide is a synthetic peptide administered through a nasal spray, and was being supplied for the study by “well-established peptide manufacturers” in Switzerland and the UK.

“We are pleased to announce the completion of the recruitment of participants in this important study,” said senior vice-president for clinical development and operations, Dr Daniil Nemenov.

“Despite the challenges encountered during this recruitment journey, including significant Covid-related restriction in Australia and New Zealand, we saw significant enthusiasm and willingness to participate in our study among the target patient population - women with distressing problems with their libido.

“This once again confirms that we are working in a field of significant unmet medical need, where orenetide may be a sought-after product.”

The company said data generated from previous clinical trials led to marketing authorisation being granted to Ovoca's subsidiary Ivix by the Russian Ministry of Health for the treatment of HSDD in Russia earlier in February.

It said the current phase 2 study would provide data in a Western population, fully compliant with the standards of the International Conference on Harmonisation that, if successful in validating the results of the Russian studies and with completion of a preclinical programme, would ultimately support further clinical development in the United States, the European Union, and internationally.

“We are delighted that all participants have been enrolled in this phase 2 study as we continue towards our goal of establishing the value of orenetide as a potential treatment for HSDD around the world,” said chief executive officer Kirill Golovanov.

“We hope that this clinical study will pave the way for the development of Orenetide in wider international markets, including the US and EU.

“We look forward to providing further updates in due course.”

At 1523 BST, shares in Ovoca Bio were up 0.05% at 9.51p.

Reporting by Josh White at Sharecast.com.