Repros Therapeutics Inc. recently announced six months interim results from the ongoing ZA-303 study on its lead pipeline candidate, Androxal. The study is evaluating the impact of Androxal therapy on bone mineral density in men suffering from secondary hypogonadism .
Interim data from the single-blind, placebo-controlled study suggested that the use of Androxal did not result in bone loss as compared to placebo. Additionally, data hinted that Androxal may improve bone mineral density.
Top-line twelve-month data from the study are expected in the second quarter of 2014. The company plans to file a New Drug Application to the U.S. Food and Drug Administration (FDA) for Androxal by mid 2014.
The company is also evaluating Androxal in other studies for secondary hypogonadism including two pivotal phase III studies conducted under the FDA’s Special Protocol Assessment program.
Earlier this year, the company had announced encouraging top-line data from the first pivotal phase III study (ZA-301). The second pivotal phase III study is expected to be completed in the fourth quarter of 2013.
Currently prescribed therapies for secondary hypogonadism include AbbVie Inc.’s (ABBV - Free Report) AndroGel.
Apart from Androxal, Proellex is another interesting pipeline candidate at Repros. Proellex is being developed for uterine fibroids (phase IIb study expected to be initiated in the fourth quarter 2013) and endometriosis (phase II study expected to be completed in the second quarter 2014).
Repros currently carries a Zacks Rank #4 (Sell). We expect investor focus to remain on Androxal updates.
Currently, companies like Actelion Ltd. and Biogen Idec Inc. (BIIB ) look more attractive with a Zacks Rank #1 (Strong Buy).