Repros Therapeutics (Nasdaq: RPRX) today reported interim 6 month results from the first 150 subjects enrolled into the ongoing one year placebo controlled study to assess the impact of Androxal treatment of secondary hypogonadal men and its effect on bon
Study ZA-303 is a single blind placebo controlled study with an Androxal to placebo ratio of 2:1. Men assigned to Androxal were required to exhibit morning testosterone levels of <300 ng/dL on two consecutive mornings. Men assigned to placebo had to meet all the criteria of age (<60) and BMI (>25) of those men assigned to Androxal with the exception that their testosterone level could be in the normal range.
At the 6 month time point, there is no evidence that Androxal reduces bone mineral density as assessed by DEXA scans. In addition, there is some evidence that Androxal may be beneficial to bone health. Overall, there is a consistent trend in many bone regions where an improvement of bone mineral density in comparison to placebo is observed. Subjects treated with 25 mg of Androxal exhibited a statistically significant increase in total hip bone mineral density compared to placebo (p = 0.0339). However, although one should be encouraged by these positive findings, clinically significant changes in bone mineral density generally require exposures longer than 6 months and early results do not always predict final results.
Study ZA-303 also indicates that testosterone may be more influential in maintaining bone health than previously expected. Repros was surprised to find that a relatively high percentage of subjects, 12%, screen failed due to low bone mineral density in this relatively young population (mean age 48).
Topline results from the first 150 subjects completing 12 months of exposure are expected in the second quarter of 2014. Based on the progress in this study and others, the NDA remains on track for submission in mid-2014.
The Company has requested guidance from the FDA regarding what additional work would be required to incorporate these positive findings on bone mineral density into the Androxal label under a separate IND.
About Repros Therapeutics Inc.
Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.
(c) 2013 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.