San Diego’s Neothetics Inc. announced plans to move forward with its LIPO-202 program, despite earlier failed clinical trials and the abrupt resignation last month of CEO George Mahaffey.
The company plans to start a Phase 2 trial with a modified formulation of its aesthetic drug LIPO-202, meant to treat belly fat, in the third quarter of this year.
The company anticipates having top-line data by the first quarter of 2017. This Phase 2 study will be a randomized, double-blind, placebo-controlled trial designed to assess the efficacy, safety and tolerability of a modified formulation of LIPO-202. Neothetics also plans to start a Phase 2 proof-of-concept study of LIPO-202 for the reduction of localized fat deposits under the chin, which the company anticipates having top-line data from by the end of 2016.
The company announced top-line results from two late-stage clinical trials in December. In both studies, LIPO-202 did not meet its goals. Following the Phase 3 results, the company cut its headcount from 17 to 9 employees in an effort to reduce expenses.
Neothetics had hoped the aesthetic treatment would help patients lose belly fat. The company was not targeting obese — or even marginally overweight — patients. Instead, the drug was intended “to make thin people thinner,” Mahaffey told the San Diego Business Journal last year.
“We don’t make big people little,” Mahaffey said, “Our patients are already in shape. This is for the person who works out and takes care of their diet but can’t get rid of the love handles or the pooch on their belly. It’s like spot dieting.”
The injectable drug was supposed to metabolize fat around the injected area, converting it into energy. The beta-2 receptor is what the body signals when it wants fat to be burned. LIPO-202 “tickles” the receptor the same way the body does, resulting in shrinking fat cells, Mahaffey said last year.
A detailed review of the failed clinical results identified a number of potential opportunities to improve upon the effectiveness of LIPO-202, according to a company statement. Neothetics hired expert consultants to review the results and develop a modified formulation of LIPO-202 primarily based on the drug product formulation used in the Phase 2 RESET study.
The company expects to obtain the positive results observed in the Phase 2 RESET clinical trial with the modified formulation, according to a Neothetics statement.
Since the reformulation news was announced Monday morning, Neothetics (Nasdaq: NEOT) stock has fallen over 11 percent, currently trading for $0.64 per share. The company’s stock has fallen a total of 91 percent since the failed clinical trial results were announced in mid-December.