Trimel Pharmaceuticals Corp. (TRL.TO) said Tuesday the preliminary review of early data from a ongoing phase 3 clinical trial showed that 79.9% of patients treated with CompleoTRT achieved an average serum testosterone level within the normal range.
The results exceed the threshold required by the US Food and Drug Administration to confirm the efficacy of a testosterone replacement product.
CompleoTRT is in development for the treatment of male hypogonadism, a condition that is estimated to affect more than 13 million men in the United States, with only 10% currently receiving treatment according to the latest epidemiological data.
The preliminary data was obtained from 139 hypogonadal patients who had completed 30 days treatment and laboratory analysis. Patients will be dosed for an additional 60 days and then be reanalyzed for a total of 90 days of treatment.
The study is ongoing and complete data, including statistical analysis for all patient groups, is expected to be available in the fourth quarter of 2012.
The complete efficacy and safety data package will be included in the final study analysis and will be part of the New Drug Application that the company expects to file with the FDA at the end of 2012 / early 2013.
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