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.
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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.
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By GlobalDataMultiple 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."
