Repros Therapeutics Inc. RPRX announced that it expects that top-line data from all three of the ongoing studies on Proellex can be reported by the end of the third quarter of 2016. While each of the three placebo controlled, double-blind studies has enrolled or will enroll about 45 patients, each study has a placebo arm and two drug arms – 6 and 12 mg of Proellex. Repros further stated that the first reported component of the three studies will be after four months of continuous treatment followed by an off-drug interval that will allow menses to return.
A study evaluating the low dose of oral Proellex for the treatment of uterine fibroids has finished screening with the last patient expected to be randomized by the end of Jan 2016. Moreover, an initial evaluation from a phase II study for endometriosis has shown significant reduction in pain and use of analgesics in women suffering from severe endometriosis. Taking into account this assessment, Repros has decided to finish enrollment in this study by the end of Jan 2016 with top-line data for the first four months of treatment expected by the end of the third quarter of 2016. The company believes that the study will provide adequate data to design a phase III study based on the 40-45 patients that are expected to be randomized.
Meanwhile, Repros intends to meet with the FDA to determine the phase III programs that will be required for the filing of the new drug applications for these two indications.
Repros was recently in the news when the FDA issued a complete response letter for its lead pipeline candidate, enclomiphene. The company was looking to get enclomiphene approved for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. The regulatory agency has asked the company to conduct an additional phase III study or studies on the candidate in order to get it approved for the target population.
With the FDA requiring additional studies to be conducted, there could be a significant delay before enclomiphene enters the U.S. markets. Considering that Repros has no approved product in its portfolio at the moment, the company should also expedite the development of Proellex.
Repros is a Zacks Rank #2 (Buy) stock. Some favorably ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. ACHN, Anika Therapeutics Inc. ANIK and Baxalta Incorporated BXLT. All three hold a Zacks Rank #1 (Strong Buy).
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