Lithera, a US-based clinical stage pharmaceutical company, has commenced a Phase IIb trial of LIPO-202, an injectable pharmaceutical product designed to target aesthetic reduction of subcutaneous abdominal fat.
The first patient was treated with LIPO-202 (Salmeterol Xinafoate for injection) in the Phase IIb RESET trial of 500 patients, and topline data is expected in the third quarter of 2013.
Lithera president and CEO George Mahaffey said the commencement of the RESET trial is a significant milestone in LIPO-202 development as a non-ablative treatment for the aesthetic reduction of subcutaneous abdominal fat.
"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," Mahaffey said.
The multi-centre, randomised study is designed to 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.
The placebo-controlled trial consists of four arms, in which patients are randomised in each of the arms once a week for eight weeks, with subcutaneous injections spaced evenly across the abdomen.
Multiple qualitative and quantitative measures of bulge reduction, besides 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."