Phase III VENUS I trial of Esmya (ulipristal acetate) meets all endpoints in uterine fibroids- Allergan/Gedeon Richter

Allergan and Gedeon Richter have announced positive results from Venus I, one of two pivotal Phase III clinical trials evaluating the efficacy and safety of Esmya (ulipristal acetate) in women with uterine fibroids. The study met all the co-primary and secondary endpoints with both ulipristal treatment arms achieving statistically significant results over placebo. 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%) and the 5 mg group (47.2%) achieved absence of bleeding compared to placebo (1.8%).

The secondary efficacy endpoints were the percentage of patients with absence of uterine bleeding from Day 11 to end of treatment and the change from baseline in the UFS-QOL revised Activities subscale at the end of treatment. Significantly more patients in the 10 mg group (58.3%) and the 5 mg group (43.4%) achieved absence of bleeding from Day 11 to the end of treatment compared to placebo (0%). The improvement from baseline in the UFS-QOL revised Activities subscale was significantly greater in the 10 mg group (59.0) and the 5 mg group (52.1) compared to placebo (21.2). There were no treatment-related serious adverse events. No patients discontinued ulipristal acetate treatment due to adverse events. The most common adverse events (= 5%) on ulipristal acetate treatment were hypertension (N=6), blood creatine phosphokinase increased (N=5), hot flush (N=5), and acne (N=3).

Comment: Venus I is the first clinical trial to report topline results. The second of two clinical trials--Venus II--is anticipated to be completed this year with topline 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.