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(Sharecast News) - Biopharmaceutical developer Ovoca Bio's shares were plummeting on Thursday, after it released a summary of the top-line results from its phase two dose-ranging study evaluating Orenetide.
The AIM-traded company said the study was conducted in Australia and New Zealand, and aimed to assess the effect of different doses of Orenetide on sexual desire in women
It said the study did not demonstrate statistically significant superiority of Orenetide compared to placebo on the co-primary endpoints of sexual desire, as measured by the Female Sexual Function Index (FSFI) desire domain, and the degree to which participants were bothered by low sexual desire, as measured by the Female Sexual Distress Scale (FSDS-DAO).
Additionally, other secondary efficacy endpoints also did not show a statistically significant difference compared to placebo.
The safety profile of Orenetide observed in the study was consistent with its previously-known safety profile, and no new safety signals were identified.
"We are surprised and disappointed that the study did not have a positive conclusion regarding the superiority of Orenetide versus placebo," said the firm's senior vice-president for clinical development and operations, Dr Daniil Nemenov.
"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.
"While we are naturally disappointed with these results, I would like to thank all those involved in the study to date, including the patients who were enrolled, their families, our investigators, staff, and all of the dedicated Ovoca employees."
Ovoca Bio said the phase two dose ranging study began in 2021 and ended in 2022, with a total of 667 women screened for the study, and 453 participants randomised and started treatment across 13 sites in Australia and New Zealand.
Of those, 425 participants completed treatment with Orenetide or placebo, and 390 participants completed the entire study.
It said Orenetide, a synthetic peptide administered through a nasal spray, was supplied for the study by established peptide manufacturers in Switzerland and the UK.
"Following receipt of the study results, Ovoca will complete a detailed 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 the company should continue with its development of the product, and any implications this may have for the wider strategy of the company," the board said in its statement.
"Further announcements will be made as and when appropriate.
"As at 31 July, Ovoca has an unaudited cash balance of €2.6m."
At 1408 BST, shares in Ovoca Bio were down 80.43% at 2.74p.
Reporting by Josh White for Sharecast.com.
