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.
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, companies like Transcept Pharmaceuticals, Inc. , Cleveland BioLabs, Inc. and QLT Inc. look more attractive with a Zacks Rank #1 (Strong Buy).