Androxal meets primary endpoints in study of Secondary Hypogonadism - Repros Therapeutics

Repros Therapeutics reported top line results from the second of two identical pivotal studies comparing Androxal to a leading FDA approved topical gel (Androgel 1.62) and placebo, for treatment of Secondary Hypogonadism. In this study, ZA-304, Androxal met the primary efficacy endpoints and demonstrated the reproducibility of our previous study results. Analyses found Androxal to be superior to the topical gel in both co-primary endpoints: percent change from baseline in average sperm concentration and percent of subjects considered to be responders. A responder is defined as an individual achieving a 24 hour average testosterone in the normal range with associated average sperm concentration more than 10 million/mL.

Multiple secondary endpoints including 24 hour serial average of testosterone, LH, FSH, and 1 week post treatment assessment of morning testosterone also showed statistically significant differences between the Androxal and T gel groups with results similar to the previously reported study, ZA-305. Data shows: 44.2% of Topical T subjects below 10 million sperm/mL at end of study versus 2.4% and 0.0% respectively for Androxal and placebo. In addition, there was a 71.5% reduction from baseline sperm concentration for Topical T subjects versus 1.3% decrease for Androxal subjects. Finally, 16.3% responder rate for Topical T versus 61.0% rate for Androxal. Androxal also maintains normal levels of endogenous T one week after dosing cessation (377 ng/dL, comparison to Topical T. All dose arms exhibited acceptable safety and no new safety signals were identified in this study.