Repros Therapeutics (RPRX) Announces Proellex Phase 2 Results

September 7, 2016 4:08 PM EDT

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Repros Therapeutics Inc. (Nasdaq: RPRX) today provided the results of the first course of treatment from Repros’ ongoing study of Proellex® for the treatment of premenopausal women with confirmed symptomatic endometriosis.

The study was a Phase 2, double-blind study of oral Proellex® (telapristone acetate) in a population of women with moderate to severe confirmed endometriosis defined as a baseline BBSS Score (Biberoglu and Behrman Symptom Score) of 7 or greater. Subjects were randomized to 6 or 12 mg of Proellex® or placebo in a 1:1:1 fashion. A course of treatment lasted 18 weeks and was followed by an Off Drug Interval. Subjects kept daily diaries recording assessments of pain, menstrual bleeding and analgesic use.

The study randomized 60 subjects, 13 in Argentina and 47 in the US. The subjects’ mean age was 30 years. As anticipated, 70% of subjects treated with Proellex® became amenorrheic. The induction of amenorrhea was associated with a substantial reduction in reported pain and subsequent reduction in analgesic use. Responses were similar across the two doses of Proellex® and are reported here pooled.

Subjects assessed menstrual and non-menstrual pain daily during baseline and treatment. The median percentage change from baseline in the patient BBSS assessment of menstrual pain showed that subjects improved with an 85.4% reduction in baseline score (p < 0.0001). In addition, despite evidence of a placebo response, subjects treated with Proellex® had a statistically significant greater reduction in menstrual pain compared to the 37.5% change from baseline achieved with placebo (p = 0.0008). Although non-menstrual pelvic pain was also reduced with treatment, a difference between treatment groups could not be detected.

Encouragingly, the improvement in menstrual pain translated to a reduction in the use of analgesics. During this first course of treatment, subjects treated with Proellex® experienced a 56% reduction in total pill count while placebo-treated subjects’ pill use declined by 30% (p = 0.0521). The reduction in non-prescription use was most striking: Proellex®-treated subjects had a 74% reduction while placebo-treated subjects only experienced a reduction of 11% (p = 0.0423).

Treatment with Proellex® was generally well tolerated.

Given these results, the Company is preparing to interact with the FDA to discuss plans for late stage development of Proellex® and Phase 3 studies to treat women who struggle with painful menses.

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