Repros Therapeutics Inc. recently provided an update on its phase III program, Androxal indicated for the treatment of secondary hypogonadism.
The company has started randomizing subjects in the first of the two pivotal phase III studies, ZA-301, at different clinical sites in the US. The second phase III study, ZA-302 is expected to start patient enrollment after the completion of patient enrollment in ZA-301.
We note that the two phase III studies are being conducted under the Food and Drug Administration’s (FDA) Special Protocol Assessment (SPA) program. In July 2012, the company had announced that it has reached an agreement with the FDA regarding the phase III study design for Androxal.
Repros Therapeutics expects to provide an update from the first pivotal study in the fourth quarter of 2012. The company believes it will be able to report results from the study in the second quarter of 2013.
The company is also conducting a six-month open label study, ZA-300 (n~500), to build a safety database as required by the US regulatory body.
The study has enrolled of 158 men till date and 62 men completed 6 weeks of treatment with the 12.5 mg dose.
Finally, Repros Therapeutics has also started enrolling patients for the one-year study DEXA (ZA-3030), which will evaluate the effects of Androxal on bone mineral density.
The company expects to file a New Drug Application (NDA) for Androxal in the first half of 2014.
Repros Therapeutics believes its current cash position will support the development of Androxal and studies being conducted with Proellex. The company expects the funds to be sufficient up to mid 2014.
We note currently approved treatments include Endo Health Solution Inc.’s (ENDP - Free Report) , Fortesta and Auxilium Pharmaceuticals, Inc.’s Testim.
We currently have an Underperform recommendation on Repros Therapeutics. The stock carries a Zacks #4 Rank (‘Sell’ rating) in the short run.