Business
Primary Endpoints Met in Libicore Phase III Study
Primary Endpoints Met in Libicore Phase III Study.
About this update from Talisman Metals Plc
[{"type":"text","content":"\n \nRNS Number : 7919T Ovoca Bio PLC 25 March 2019 \n\n \n \nOvoca Bio plc's Libicore (BP-101) Meets Primary/Secondary Endpoints in Phase 3 Trial for Hypoactive Sexual Desire Disorder Ahead of Time\n· Phase 3 study of Libicore (BP-101) for hypoactive sexual desire disorder (HSDD) in premenopausal women met the pre-specified primary efficacy endpoint of improvement in number of sexually satisfying events:\no In the trial, Libicore (BP-101) showed a statistically significant increase in the number of satisfying sexual events (SSEs) versus placebo (difference in the mean increase in SSEs of 1.83 (95% CI of 0.28-3.39) at the tested daily dose of 2.52mg (p = 0.016)\n· Statistically significant results versus placebo also were seen in the key registration endpoints of:\no Female Sexual Function Index: Desire Domain (FSFI-D) showed a statistically significant mean increase of 1.14 (0.94-1.34) for Libicore (BP-101) vs. 0.58 (0.38 - 0.78) on placebo, p=0.0001; and, \no The Female Sexual Distress Scale - revised (FSDS-R) Item 13 showed a statistically significant mean reduction of -1.2 (-1.4 to -1.0) vs. -0.7 (-0.9 to -0.5), p=0.0019.\n· The pivotal clinical trial, evaluating the efficacy and safety of Libicore (BP-101) versus placebo was stopped early based on the achievement of pre-specified efficacy criteria.\n· Following these results, Ovoca anticipates filing for approval of Libicore (BP-101) in the Russian Federation, where the clinical program has been conducted to date, in the 2nd Quarter of 2019.\nOvoca Bio plc (LSE: OVB; ISE:OVXA), a biopharmaceutical company focused on identifying and developing novel therapeutics targeting the large unmet needs in the treatment of female sexual dysfunction, today announced positive, statistically significant top-line results from a Phase 3 clinical trial of its first candidate, Libicore (BP-101). Ovoca acquired a majority interest in IVIX LLC (IVIX) in September 2018, a company that has sought to develop and commercialize its investigational drug candidate, Libicore (BP-101), since its formation in 2012.\n \nThe pivotal study investigating first-in-class Libicore as an intranasal treatment for premenopausal women diagnosed with hyp...