Lithera has announced the treatment of first patient with LIPO-202 (Salmeterol Xinafoate for Injection) in the Phase IIb RESET trial.
LIPO-202 is an injectable pharmaceutical designed to produce aesthetic reduction of subcutaneous abdominal fat.
Lithera president and CEO George Mahaffey said, "Following our recent Series C financing, Lithera is focused on advancing LIPO-202 in the clinic as we see tremendous potential for the drug to address a significant opportunity in aesthetic medicine - the ability to offer a quick and minimally invasive 'lunch time' procedure with no patient down time that effectively reduces abdominal fat."
The study will compare the efficacy of three different doses of LIPO-202 to placebo on abdominal bulging due to excess subcutaneous fat in healthy, non-obese subjects.
Patients will be randomised in each of the four arms of the placebo-controlled study once every week for eight weeks with subcutaneous injections spaced evenly across the abdomen.
Multiple qualitative and quantitative measures of bulge reduction in addition to safety information are the endpoints of the trial.
Lithera chief medical officer Murray Maytom said, "The RESET trial incorporates indication-specific objective and subjective efficacy measures, as well as a suitably large sample size in order to provide what we hope to be a very clear demonstration of LIPO-202's effectiveness and a definition of its optimal dose."
Topline data from the multi-center, randomised trial of 500 patients is expected in the third quarter of 2013.
