25th Mar 2019 12:13
LONDON (Alliance News) - Ovoca Bio PLC on Monday said it intends to file for the approval of its hypoactive sexual desire disorder drug Libicore in Russia after positive results from a recent trial.
Shares in the pharmaceutical developer were up 19% at 8.04 pence on Monday.
There were 184 female patients enrolled in the phase three trial, which took place in Russia, all of whom were pre-menopausal.
Results showed that Libicore produced a "statistically significant increase in the number of satisfying sexual events" when compared to a placebo. This was the primary endpoint of the study.
Moreover, the drug also met its secondary endpoints of increasing female sexual function and decreasing female sexual distress.
The trial was stopped early, after interim analysis was conducted, because the drug had achieved its stated outcomes.
Following these encouraging results, Ovoca intends to file for approval of Libicore in Russia in the second quarter of 2019.
Ovoca acquired IVIX LLC in the summer of 2018, as well as IVIX's clinical stage asset Libicore, and shifted focus to pharmaceuticals. Prior to that, Ovoca was a mining exploration company.
Ovoca Chief Executive Kirill Golovanov said: "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. 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 [US Food & Drug Administration] approved therapy, we believe that Libicore has the potential to address a significant unmet medical need."
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