Ovoca Bio confirms positive results from Libicore phase 3 trial

Biopharmaceutical company Ovoca Bio announced positive, statistically significant top-line results from a phase 3 clinical trial of its first candidate, ‘Libicore’ (BP-101), on Monday.

The AIM-traded firm said it acquired a majority interest in IVIX in September last year - a company that had sought to develop and commercialise its investigational drug candidate, Libicore, since its formation in 2012.

It said the pivotal study investigating first-in-class Libicore as an intranasal treatment for premenopausal women diagnosed with hypoactive sexual desire disorder met the pre-specified primary efficacy endpoint, and achieved “significant” outcomes in key supporting secondary endpoints.

Following a planned interim analysis conducted by an independent data monitoring committee, Ovoca Bio said the committee recommended to stop the trial early as the primary endpoint had reached its pre-specified criteria for superiority.

“We are excited with the trial result, which achieved clinical and statistical significance in the primary endpoint and key secondary endpoints using validated measurement tools,” said Ovoca Bio chief executive officer Kirill Golovanov.

“This represents the successful achievement of one of the key milestones we outlined when we completed the acquisition of IVIX last year.

“With approximately 1-in-10 adult women experiencing a distressing loss of libido and only a single FDA-approved therapy, we believe that Libicore has the potential to address a significant unmet medical need.”

Daniil Nemenov - medical director of the Libicore programme - added that in its clinical program, Libicore had been used on a daily basis by premenopausal women with hypoactive sexual desire disorder, and had consistently shown sustained efficacy after one month of treatment, and a further two months follow-up.

“In this phase 3 study, Libicore provided clinically significant benefit without troublesome side effects to patients.

“Furthermore, our approach has the strong potential to provide women suffering from hypoactive sexual desire disorder with a convenient dosage form without the need for injections or inconvenient restrictions associated with current treatment options, or those in late stages of development.

“We look forward to the opportunity to provide a new and differentiated treatment solution.”