Lipo-202 didn’t meet co-primary composite and secondary endpoints in the AbCONTOUR1 and AbCONTOUR2 Phase 3 trials, but the company plans to continues to analyze data. Stock prices plummetted after the news was reported.
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 the 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,” said George Mahaffey, president and chief executive officer of Neothetics, in a news release. “We continue to analyze the data from AbCONTOUR1 and AbCONTOUR2 to fully understand the trial results and to evaluate our future plans.”
LIPO-202 is an injectable formulation of salmeterol xinafoate, a long-acting ß2-adrenergic receptor agonist used in several US Food and Drug Administration-approved drugs, including ADVAIR® for asthma. Neothetics’ studies suggest that salmeterol xinafoate also activates ß2-adrenergic receptors on fat cells, triggering the breakdown of triglycerides stored in the cells, causing them to shrink via lipolysis.
AbCONTOUR1 and AbCONTOUR2 were randomized, double-blind, placebo-controlled Phase 3 trials designed to assess the efficacy, safety, and tolerability of LIPO-202 (total weekly dose of 0.4 mcg for 8 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 US.