Clarus Therapeutics has announced positive top-line results from a Phase III study of CLR-610, an oral testosterone (T) replacement drug.
The study met its primary efficacy endpoint with 87% of the 141 men treated with CLR-610 achieving average serum T levels (C-avg) in the normal range (between 300 – 1,000ng/dL), within the 90-day treatment phase.
Clarus chief medical officer Dr Bela Denes said a significant number of men receiving CLR-610 achieved normal T levels in the study.
"Market research shows that men currently being treated for low T with transdermal or injectable products would overwhelmingly prefer an oral option. Thus, we believe CLR-610 will have strong appeal," Denes said.
A C-avg of 624ng/dL was observed in men treated with CLR-610, while a C-avg of 480ng/dL was observed in the T-gel comparison arm.
No evidence of liver toxicity was observed in men treated with CLR-610 or T-gel, which is consistent with Phase II results.
Harbor-UCLA Medical Center Department of Medicine endocrinology division chief and LA Biomedical Research Institute Phase III study principal investigator Dr Ronald Swerdloff said the results and feedback received from trial participants are encouraging.
"The convenience of an oral T replacement option is one that I believe patients and their healthcare providers will embrace," Swerdloff said.