Repros Therapeutics Inc.
) announced it has completed enrollment for one of the two
head-to-head studies on its secondary hypogonadism candidate,
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The two identical, 17-week, double-blind studies will compare the
safety and efficacy of Androxal with a testosterone replacement
therapy (topical gel) and placebo in restoring and maintaining
testicular function. The primary endpoint of the study is to find
if Androxal is superior to both placebo and the topical gel based
on normal testosterone levels and normal sperm concentrations
achieved by patients.
While the first study (ZA-305) enrolled 120 men, the second study
(ZA-304) will also enroll the same number of patients. The
enrollment process for ZA-304 is expected to be completed in the
next few weeks.
Top-line data from the studies are expected by Oct 2014. Repros
plans to submit a new drug application (NDA) to the U.S. Food and
Drug Administration (FDA) in the fourth quarter of 2014.
We note that earlier this year, Repros had announced the outcome
of its meeting with the FDA. The meeting was held to discuss
phase III data requirements to file an NDA for Androxal.
Following the meeting, the company came to the conclusion that no
additional safety studies would be required to support the NDA
submission of Androxal. The safety of Androxal will stand on its
own merit during NDA review.
Currently prescribed therapies for secondary hypogonadism include
Repros currently carries a Zacks Rank #4 (Sell). We expect
investor focus to remain on Androxal updates. Some better-ranked
biopharma stocks include
Regeneron Pharmaceuticals, Inc.
), both carrying a Zacks Rank #1 (Strong Buy).