Ardana's testosterone cream sees good Ph II data

Edinburgh, UK-based drugmaker Ardana has reported positive results from a Phase II dose-finding clinical study of its testosterone cream in hypogonadal men which, it says, provided "clear evidence" of the effectiveness of its bi-gel technology for the transdermal delivery of this key hormone.

The double-blind, randomized, placebo-controlled study involved 42 men diagnosed with confirmed testosterone deficiency and data from the trial show that maximal serum concentration was achieved between 10 and 12 hours after the application. For the three doses, 1.5g, 2.25g and 3.0g, the average concentrations of testosterone over 24 hours were 2.06ng/ml, 2.13ng/ml and 2.63ng/ml and the maximal concentrations were 3.35ng/ml, 3.53ng/ml and 5.66ng/ml, respectively.

The male hypogonadism market has experienced rapid growth over the last five years, driven by novel gel formulations, which now make up 76% of the sector's value. Ardana estimates the current US market size for its product at $473.0 million per year. To advance the agent, the firm has also initiated a further one-month Phase II study in hypogonadal men and a pivotal Phase III registration study is expected to be completed by end of the year.