Repros Therapeutics Reports Additional Results For Study ZA-302

(RTTNews) - Repros Therapeutics Inc. (RPRX) reported additional topline results for study ZA-302, the second pivotal efficacy study for Androxal. The results of both pivotal studies, ZA-301 and ZA-302, have met the SPA co-primary endpoints as defined by the FDA.

Study ZA-302 had no detected site anomalies. The company said it has conducted several placebo controlled trials of Androxal in the treatment of secondary hypogonadism. In every study Androxal achieved highly statistically significant and clinically relevant improvement in testicular function as evidenced by improved endogenous production of the male hormone.

Importantly, Androxal improves pituitary secretions of important hormones necessary to maintain normal testicular function including both testosterone synthesis and spermatogenesis. This feature distinguishes Androxal from all of the testosterone replacement therapies which, via the negative feedback on the pituitary of exogenous testosterone, result in suppression of pituitary signaling and testicular function.

The company noted that in all placebo controlled Androxal studies, it has been observed that at any given time approximately 20% of secondary hypogonadal men will be in the normal range. These men still have a functional hypothalamic-pituitary-testes axis, unfortunately it does not function consistently. In these men, hormone replacement therapy results in complete suppression of the axis in about 40% of subjects based on Repros studies.

In previously reported results for study ZA-301, the company reported 1 subject on placebo and 15 subjects on drug dropping below 50% of baseline sperm concentrations. In the final study analysis this changed to 1 and 16 in the final ITT but the conclusions of the analyses were no different than previously reported.