31st Aug 2023 12:08
(Alliance News) - Ovoca Bio PLC shares plummeted on Thursday, after it said that a study into Orenetide did not show statistically significant superiority versus placebo.
Shares in Ovoca were down 43% to 8.00 pence each in London on Thursday around midday.
The women's health-focused biopharmaceutical company announced that the top-line results from its phase two dose-ranging study assessing Orenetide did not show statistically significant superiority versus placebo on its co-primary endpoints.
The study evaluated the effect of a range of daily administered Orenetide doses on a lack or loss of sexual desire in 667 women.
Its co-primary endpoints were sexual desire, as measured by the female sexual function index desire domain, and the degree to which a participant is bothered by low sexual desire, as measured by the female sexual distress scale.
Other secondary efficacy endpoints were also shown not to have statistically significant differences versus a placebo.
It added that the safety profile of Orenetide observed in the study was "consistent" with its previously known safety profile, and no new safety signals were identified.
Following the results, Ovoca will complete an investigation of the study datasets and, based on the findings from these further investigations, will determine the appropriate future strategy regarding the development of Orenetide, including whether it should continue with its development of the product, and any implications this may have for the wider strategy of the company.
Daniil Nemenov, senior vice president for Clinical Development & Operations said: "We are surprised and disappointed that the study did not have a positive conclusion regarding the superiority of Orenetide versus placebo. The company now intends to analyse the results from the study in further detail, including investigating the reasons for potential differences between the study results and results from previously conducted clinical trials of Orenetide."
By Sophie Rose, Alliance News reporter
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