Phase III trial of LIPO 202 (salmeterol xinafoate for injection) fails to meet endpoints in subcutaneous fat reduction- Neothetics

Neothetics has announced top-line results from its AbCONTOUR1 and AbCONTOUR2 US-based pivotal Phase III trials to evaluate the safety and efficacy of LIPO 202 (salmeterol xinafoate for injection) for the reduction of central abdominal bulging due to subcutaneous fat. AbCONTOUR1 and AbCONTOUR2 were randomized, double-blind, placebo-controlled Phase III trials designed to assess the efficacy, safety, and tolerability of LIPO-202 (total weekly dose of 0.4 µg for eight weeks) for the reduction of central abdominal bulging. The trials enrolled a total of 1,584 patients randomized 1:1 to LIPO-202 or placebo. The trials were conducted at approximately 80 clinical sites across the U.S.

In both studies, LIPO 202 did not meet its co-primary composite and secondary endpoints. The co-primary endpoints were the proportion of subjects who reported an improvement of at least one point on the Patient-Global Abdominal Perception Scale (P-GAPS) and an improvement of at least two points on the Clinician Photonumeric Scale (CPnS) and the proportion of subjects who reported an improvement of at least two points on the P-GAPS and an improvement of at least two points on the CPnS. LIPO 202 continued to show a benign safety profile in these trials.