Positive results for ulipristal in uterine fibroids late-stage trial

Ireland-incorporated Allergan (NYSE: AGN) and Hungary's largest drugmaker Gedeon Richter (RICHT: HB) have announced positive results from Venus I, one of two pivotal Phase III clinical trials evaluating the efficacy and safety of ulipristal acetate in women with uterine fibroids.

The study included 157 patients, with 101 patients randomized to ulipristal acetate 5mg and 10mg and 56 to placebo. The study met all the co-primary and secondary endpoints with both ulipristal treatment arms achieving statistically significant results over placebo (p<0.0001). The co-primary efficacy endpoints were percentage of patients with absence of uterine bleeding and time to absence of uterine bleeding. Significantly more patients in the 10 mg group (58.3%; p<0.0001) and the 5 mg group (47.2%; p<0.0001) achieved absence of bleeding compared to placebo (1.8%).

Venus I is the first clinical trial to report top-line results. The second of two clinical trials - Venus II - is anticipated to be completed this year with top-line results expected in the first half of 2017. A new drug application for the treatment of uterine fibroids is planned to be submitted in 2017.