Repros Therapeutics Inc.’s share price increased 1.2% last week on the announcement that the company has initiated two studies on its secondary hypogonadism candidate, Androxal. Since then, the company has gained approximately 5.4%.
The two identical, 17-week, double-blinded, placebo controlled studies will compare the safety and efficacy of Androxal with a testosterone replacement therapy (topical gel) in restoring and maintaining testicular function. Both studies will enroll 120 men each. Top-line data from the studies are expected by Oct 2014. Repros plans to submit the new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2014.
Repros has already obtained the Investigational Review Board approval for several of the study sites. Meanwhile, several sites have started pre-screening patients with the drug shipment for the trial expected shortly.
We remind investors that the company had received guidance from the FDA related to the Androxal development program in Oct 2013. In view of the guidance, Repros delayed the regulatory submission from the previously expected timeline of mid-2014.
Last year, the company had announced encouraging top-line data from the first pivotal phase III study (ZA-301) and the second pivotal efficacy study (ZA-302), which evaluated Androxal for secondary hypogonadism. Both ZA-301 and ZA-302 – conducted under the FDA’s Special Protocol Assessment (SPA) program – had met their respective primary endpoints.
We believe that Repros stands to benefit from the additional trials as data, if positive, can be added to the label. Currently prescribed therapies for secondary hypogonadism include AbbVie Inc.’s (ABBV - Free Report) AndroGel.
Repros currently carries a Zacks Rank #3 (Hold). We expect investor focus to remain on Androxal updates. Some better-ranked stocks in the biopharma space include Actelion Ltd. and Jazz Pharmaceuticals (JAZZ - Free Report) . Both carry a Zacks Rank #1 (Strong Buy).