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Summary Results of Phase II Study for Orenetide
Summary Results of Phase II Study for Orenetide.
About this update from Talisman Metals Plc
[{"type":"text","content":"\n\nOvoca Bio PLC\n31 August 2023\n \nThis announcement contains inside information\n \nOvoca Bio plc\n \n(\"Ovoca\" or the \"Company\")\n \nOvoca Bio Announces Summary Results of Phase II Dose Ranging Study Assessing Orenetide for HSDD\n \nDublin, Ireland, 31 August 2023 - Ovoca Bio, a biopharmaceutical company with a focus on women's health, announces a summary conclusion of the top-line results from its Phase II dose ranging study assessing Orenetide conducted in Australia and New Zealand (the \"Study\").\n \nStudy Results Summary\nThe Study did not show statistically significant superiority of Orenetide versus placebo on the co-primary endpoints of (1) sexual desire, as measured by the Female Sexual Function Index (FSFI) desire domain, and (2) the degree to which a participant is bothered by low sexual desire, as measured by the Female Sexual Distress Scale (FSDS-DAO). Other secondary efficacy endpoints were also shown not to have statistically significant difference vs. placebo. The safety profile of the Orenetide observed in the Study was consistent with its previously known safety profile, and no new safety signals were identified.\n \nDr. Daniil Nemenov, SVP for Clinical Development and Operations of Ovoca Bio plc, 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. While we are naturally disappointed with these results, I would like 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.\"\n \nStudy Process\nThe Phase II dose ranging study was conducted in Australia and New Zealand throughout 2021 and 2022 in order to evaluate the effect of a range of daily administered Orenetide doses on a lack or loss of sexual desire experienced by Study participants prior to the Study. In total, 667 women were screened in the double-blind placebo-controlled Study, with a final 453 participants were randomized and started treatment across 13 sites. Of th...