Repros Therapeutics Inc.
) recently provided top-line results from the ZA-301 study on its
late-stage candidate, Androxal, which is being evaluated for the
treatment of secondary hypogonadism. The ZA-301 study met both
the primary endpoints.
The phase III program on Androxal includes two identical pivotal
phase III studies, ZA-301 and ZA-302. The ZA-301 study had 151
patients randomized in a 3:1 ratio; 113 on Androxal and 38 on
The results showed that 79% of the patients had a 24-hour average
total testosterone in a normal range at the end of the 12-week
study period. Completer - a separate analysis - showed 83% of men
were within the normal testosterone range.
The second primary endpoint was related to the drug's impact on
sperm concentration, which met the FDA threshold criteria as
Androxal exhibited non-inferiority to placebo at a margin of 20%.
Repros reported that Androxal was generally well-tolerated with
no adverse events leading to discontinuation in the Androxal arm.
Earlier this year, the company had announced that it has
completed the enrollment process in the one-year study, DEXA
(ZA-303), evaluating the effects of Androxal on bone mineral
density. The company completed enrollment three months before the
We are encouraged by the positive data from the ZA-301 study.
Although the testosterone replacement therapy (TRT) market is
pretty crowded, it nevertheless represents huge potential.
According to information provided by Repros, around 13 million
men in the US are estimated to suffer from low levels of
testosterone. Moreover, the company said that about 70% of men
that have low testosterone suffer from secondary hypogonadism.
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Androxal, which is being developed as an oral therapy for the
treatment of the cause of secondary hypogonadism, could provide
patients with a differentiated treatment option once launched.
Currently, the most used treatment for secondary hypogonadism is
testosterone replacement therapy. The market has products like
Axiron (testosterone solution), Testim (testosterone gel),
AndroGel (testosterone gel) and Androderm (patch therapy).
Repros currently carries a Zacks Rank #4 (Sell). Currently,
Transcept Pharmaceuticals, Inc.
Cleveland BioLabs, Inc.
Biogen Idec Inc.
) look more attractive with a Zacks Rank #1 (Strong Buy).