Repros Therapeutics Inc.
) recently announced that two additional patents covering its
candidate, Androxal, have been issued. Both patents (8,372,887
and 8,377,991) related to metabolic consequences of low
testosterone and the favorable effect of restoring testicular
functions by Androxal are valid till 2028 and 2031, respectively.
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The 991' patent covering the treatment of type II diabetes was
issued on the basis of data from the phase II study (ZA-202). The
study evaluated the use of Androxal for improvement of glycemic
control in males suffering from type II diabetes, who are being
treated with oral hypoglycemic agents for their condition. The
results from the study were encouraging.
Repros is also developing Androxal for other indications
including secondary hypogonadism. Last month Repros provided
encouraging top-line results from the ZA-301 study on Androxal
for the treatment of secondary hypogonadism.
The results showed that 79% of the patients had 24-hour average
total testosterone in a normal range at the end of 12 weeks of
treatment with the drug. Completer - a separate analysis - showed
83% of men were within the normal testosterone range.
Moreover, the drug's impact on sperm concentration also met the
threshold criteria of the US Food and Drug Administration (FDA)
as Androxal exhibited non-inferiority to placebo at a margin of
20%. Repros reported that Androxal was generally well-tolerated
in the study with no adverse events leading to discontinuation in
the Androxal arm.
Repros currently carries a Zacks Rank #4 (Sell). Currently,
Transcept Pharmaceuticals, Inc.
Cleveland BioLabs, Inc.
) look more attractive with a Zacks Rank #1 (Strong Buy).