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Completion of Enrollment in Phase II Study
Completion of Enrollment in Phase II Study.
About this update from Talisman Metals Plc
[{"type":"text","content":"\n \n \n Ovoca Bio plc\n \n \n \n \n \n (\"Ovoca\" or the \"Company\")\n \n \n \n \n \n Ovoca Bio Announces Completion of Enrollment in Phase II Dose Ranging Study Assessing Orenetide for HSDD\n \n \n \n Dublin, Ireland, 29 July 2022 - Ovoca Bio, a biopharmaceutical company with a focus on women's health, today announces the successful completion of the enrollment of participants in a Phase II dose ranging study assessing Orenetide (the \"Study\"), a novel treatment for premenopausal women with hypoactive sexual desire disorder (\"HSDD\"). HSDD is a condition characterized by a distressing lack or loss of sexual desire. Despite a challenging global environment due to COVID-19 restrictions, the company is pleased to have successfully completed the enrollment in accordance with the previously announced timeline and schedule.\n \n \n \n \n \n This Phase II dose ranging Study is being conducted in Australia and New Zealand in order to investigate Orenetide administered daily at a range of doses, evaluating the effect of the drug on lack or loss of sexual desire experienced by Study participants. 667 women have been screened in this double-blind placebo-controlled Study to allow up to 462 participants to be treated across 13 sites. The\n Ovoca management team currently expects that all enrolled participants will complete the Study in the next four months, which will allow the assessment of study results in Q1 2023.\n \n \n \n \n \n The co-primary objectives of the Study are to evaluate the effect of three different doses of Orenetide and placebo, on (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. The change in those clinically relevant and validated endpoints will be assessed between a four-week baseline period and after four weeks of daily dosing. All study participants are female and have a diagnosis of acquired, generalised HSDD. Orenetide is a synthetic peptide administered through a nasal spray and has been supplied for this study by well-established peptide manufacturers in Switzerland and the UK.\n \n \n \n \n \n More information about the Phase II study can be found through clicking on the followi...