LPCN 1021: Phase III data

Top-line data from the efficacy population in the open-label, U.S. Phase III SOAR trial in 315 patients with hypogonadism showed that twice-daily oral LPCN 1021 met the primary endpoint of >=75% of patients on active treatment achieving an average 24-hour serum testosterone concentration within the normal range of 300-1,140 ng/dL at week 13 at a lower bound of the 95% CI of >65%. Specifically, 88.2% of patients achieved the endpoint at a lower bound of the 95% CI of 81.9%. The primary efficacy population consisted of patients with >=1 pharmacokinetic profile and no significant protocol deviations (n=152). Additionally, LPCN 1021 led to an average 24-hour serum testosterone concentration of <300 ng/dL in 11.2% of patients and an average 24-hour serum testosterone concentration of >1,140 ng/dL in 0.7% of patients. ...