Ovoca Bio announced the summary of the main results of the Phase II dose ranging study of Orenetide conducted in Australia and New Zealand. This study did not demonstrate statistically significant superiority of Orenetide over placebo on the primary endpoints (1) sexual desire, as measured by the desire domain of the Female Sexual Function Index (FSFI), and (2) participants’ level of distress. low sexual desire, as measured by the Women’s Sexual Distress Scale (FSDS-DAO). Other secondary efficacy endpoints were also found to have no statistically significant differences versus placebo.

placebo. The safety profile of Orenetide observed in this study was consistent with its previously known safety profile and no new safety signals were identified. A Phase II dose ranging study was conducted in Australia and New Zealand in 2021 and 2022 to evaluate the effect of a series of Orenetide doses administered daily on the lack or loss of sexual desire experienced by pre-study participants.

A total of 667 women were screened in a double-blind, placebo-controlled study, and 453 participants were eventually randomized and started on treatment at 13 sites. Of these, 425 participants completed either Orenetide or placebo treatment and 390 completed the entire study. The main objective of this study was to evaluate the effect of three different doses of Orenetide and placebo on (1) sexual desire, as measured by the desire domain of the Female Sexual Function Index (FSFI); and (2) the extent to which participants experienced low sexual desire, as measured by the Female Sexual Pressure Scale.

All study participants were women and had a commonly acquired diagnosis of HSDD. Orenetide is a synthetic peptide administered via nasal spray and was supplied for this study by leading peptide manufacturers in Switzerland and the United Kingdom.