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Repros Reveals Positive Data on Proellex for Uterine Fibroids

Repros Therapeutics Inc. RPRX announced positive data from a phase IIb study on Proellex (vaginal administration) for the treatment of women suffering from uterine fibroids.

The study evaluated Proellex, in comparison to placebo, in patients with confirmed uterine fibroids. Data from the study demonstrated that vaginal administration of Proellex, at both 6 mg and 12 mg dosages led to a significant reduction in excessive menstrual bleeding in women with uterine fibroids. Subjects in the Proellex arm revealed a median 100% reduction in diary reports of menstrual bleeding product usage, compared to a 25.4% reduction in the placebo arm. Moreover, 52% of Proellex-treated subjects experienced a cessation of menses with no evidence of dose effect compared to zero for placebo. The candidate was generally well tolerated.

Currently, patients in the study are being treated with a second course of treatment for 18 weeks. These data are expected within the next five months.

We remind investors that Repros is evaluating low doses of oral Proellex in a phase IIb study for the same indication. Results are expected in the second quarter of 2016.

After completing two 18-week courses of treatment for both the vaginal and oral studies, the company plans to hold an end of Phase II meeting with the FDA to discuss the prospects of advancing the candidate into a phase III study.

We note that woman with excessive menstrual bleeding, greater than 80 mL (normal ~35 mL), are considered to be suffering from menorrhagia or excessive menstrual bleeding, a key symptom of uterine fibroids.

Repros currently spots a Zacks Rank #1 (Strong Buy). AMAG Pharmaceuticals, Inc. AMAG, Anika Therapeutics Inc. ANIK and Emergent BioSolutions, Inc. EBS, are some top-ranked peers carrying the same rank as Repros.

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