Phase III research looking at the use of LIPO-202 (Neothetics), injectable salmeterol xinafoate, designed to shrink localized fat cells, for abdominal body contouring failed. But Neothetics hasn’t given up on LIPO-202 and recently announced the start of a phase II proof of concept study of LIPO-202 for submental subcutaneous fat reduction.
We first reported on the start of the phase III trial in this story on March 17, 2015. But the phase III trial didn’t meet its primary or secondary endpoints and had unequivocally negative results. The drug’s safety profile, however, remained benign.
A Neothetics representative tells Cosmetic Surgery Times that when the phase III trial failed in December 2016, the company did a comprehensive review of the negative data. Their review revealed that the protocol was correctly followed, but they discovered that modifications made to LIPO-202 between the injectable’s phase II and phase III studies may have affected the drug’s performance in phase III.
As a result, the company is proceeding with a modified drug product similar to that used in the successful Phase II RESET trial. In addition the company decided to focus resources and efforts on submental fat reduction. Results from phase II proof of concept trial, LIPO-202-CL-31, are expected late second quarter of 2017.
LIPO-202-CL-31 is a multi-center, randomized, double-blind, placebo-controlled proof of concept trial. Researchers are injecting about 150 patients in the submental area, with up to 30 subcutaneous LIPO-202 injections or placebo once a week for eight weeks. Subjects will receive either 0.3 mcg, or 3.0 mcg dose of LIPO-202 or placebo, according to a Neothetics press release.
LIPO-202 is an injectable formulation of salmeterol xinafoate. It reduces the size of the fat cell without killing it and without causing damage to nearby tissues. Salmeterol xinafoate, a long-acting ß2-adrenergic receptor agonist, is used in FDA-approved drugs, including ADVAIR (GSK) for asthma.