LCPN 1021 enters Phase III trial for Testosterone Deficiency-Lipocine

The first patient has been dosed in a the Study of Oral Androgen Replacement (SOAR) pivotal Phase III clinical trial for LPCN 1021 from Lipocine. The trial is designed to evaluate the safety and efficacy of LPCN 1021, an oral testosterone replacement therapy, in hypogonadal men with Low Testosterone. Approximately 300 patients are expected to be enrolled in multiple sites in the United States.

The company expects to report top-line efficacy data for the trial in the second half of 2014 with a New Drug Application ("NDA") filing with the FDA anticipated in the second half of 2015. The co-primary endpoints of the study will be the percentage of subjects achieving 24-hour average total serum testosterone concentration (Cavg(0-24)) within the normal range of 300�1140 ng/dL after completion of 13 weeks of treatment, as well as a measure of the lower bound of the 95% confidence interval for Cavg(0-24). Secondary endpoints of the study are based on the maximum serum total testosterone concentration (Cmax) after completion of 13 weeks of treatment.