Pharma and Biotech
By Josh White
Date: Friday 29 Jan 2021
LONDON (ShareCast) - (Sharecast News) - Biopharmaceutical company Ovoca Bio said on Friday that the first patient has been enrolled in a phase 2 dose-ranging study assessing 'BP-101', which it described as a novel treatment for premenopausal women with hypoactive sexual desire disorder (HSDD) - a condition characterised by a distressing lack or loss of sexual desire.
The AIM-traded firm said the phase 2 dose-ranging study was being conducted in Australia and New Zealand and would investigate BP-101, administered daily at a range of doses, evaluating the effect of the drug on lack or loss of sexual desire experienced by participating patients.
It said the double-blind placebo-controlled study was expected to enrol 476 patients across 13 sites.
BP-101 is a synthetic peptide administered through a nasal spray, and was being supplied for this study by peptide manufacturers in Switzerland and the UK.
The co-primary objectives of the study would be to evaluate the effect of three different doses of BP-101 and placebo, on sexual desire, as measured by the Female Sexual Function Index (FSFI) desire domain; and, the degree to which a participant was bothered by low sexual desire, as measured by the Female Sexual Distress Scale.
Ovoca Bio said the change in those clinically-relevant and validated endpoints would be assessed between a four week baseline period and after four weeks of daily dosing.
"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," said chief executive officer Kirill Golovanov.
"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."
At 1020 GMT, shares in Ovoca Bio were down 6.54% at 10p.
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