Neothetics has announced results from its AbCONTOUR1 and AbCONTOUR2 U.S.-based pivotal Phase 3 trials to evaluate the safety and efficacy of LIPO-202 (injectable salmeterol xinafoate) for the reduction of central abdominal bulging due to subcutaneous fat. The Phase 3 trials were randomized, double blind and placebo controlled, designed to assess the efficacy, safety and tolerability of LIPO-202 (total weekly dose of 0.4mcg for eight weeks) for the reduction of central abdominal bulging. The trials enrolled a total of 1,584 subjects who were randomized 1:1 to LIPO-202 or placebo.
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.
“We are disappointed by these unequivocally negative results. We expected LIPO-202 to demonstrate better efficacy based on the results we saw in the Phase 2b RESET trial. We would like to express our sincere gratitude to our investigators and patients who participated in this study,” said George Mahaffey, president and CEO of Neothetics. “We continue to analyze the data from AbCONTOUR1 and AbCONTOUR2 to fully understand the trial results and to evaluate our future plans.”