Repros Initiates Two Phase 2B Uterine Fibroid Studies

Repros Therapeutics Inc.®

today announced it has initiated two Phase 2B efficacy studies of Proellex® in the treatment of uterine fibroids in women that experience heavy vaginal bleeding as a result of these benign tumors. The two studies both have the same FDA suggested endpoints but test two different routes of administration, oral and vaginal. The Company had previously tested both routes using similar doses and found that Proellex® exhibited significant effects on bleeding due to uterine fibroids with each route of administration. In addition to significant effects on bleeding due to Proellex® administration, tumor size was significantly reduced. As a result of reduced tumor burden, bulk symptoms improved to the point where the majority of subjects reported to be symptom free using the Uterine Fibroid Symptom Quality of Life survey (UFSQoL). The UFSQoL is a validated survey that was used to approve uterine artery embolization and ultrasound focusing. In earlier Phase 2 studies, both oral and vaginal administration of Proellex® stopped menses and hence, in this study, on recommendation from the FDA, Repros has chosen amenorrhea as the primary efficacy endpoint. The studies both have three double blind arms: placebo and Proellex® at 6 mg and 12 mg doses. The two studies are powered to achieve the desired impact on menstrual bleeding with only 15 subjects per arm. In addition to investigating the incidence of amenorrhea, actual menstrual blood loss will be estimated by the alkaline hematin method from used sanitary products. The studies are designed to treat women for two 4-month dosing courses separated by an off drug interval to allow for menses. Following the second course, the FDA instructed the Company to follow the women for six additional menstrual events to investigate the duration of benefit. The Company plans to request a Type C meeting after all the subjects have experienced the menstrual event following the first course of treatment. An interim assessment of efficacy and safety is part of the analysis plan. Assuming enrollment proceeds according to plan, the Company believes it can schedule a Type C meeting with the FDA around year end 2015. The purpose of this meeting will be to discuss the overall FDA proposed size of the safety database required for an NDA.