Lithera, Inc. today announced positive results from a Phase IIa clinical study of LIPO-102, its novel injectable combination of salmeterol xinafoate (SX) and fluticasone propionate (FP) for selective, non-ablative fat reduction. LIPO-102 is being studied for the treatment of exophthalmos using abdominal fat as a surrogate for periorbital fat. LIPO-102 was well-tolerated when administered weekly for 4 weeks into the subcutaneous abdominal fat of healthy subjects. Dose- and time-related reductions in abdominal circumference and skin-fold thickness measures were observed one (Week 5) and four (Week 8) weeks after the treatment period. A reduction of 3.47 cm>
"We are pleased to find LIPO-102 showing meaningful clinical changes related to local fat reduction and believe this data supports further development of LIPO-102 for exophthalmos and other indications with excess fat accumulation," said John Dobak, M.D., Chief Executive Officer of Lithera.
Fifty-four healthy adult, male and female subjects with an anterior abdominal skin-fold thickness of between 30-50 mm measured with pinch calipers were enrolled in this single-masked study. Subjects were randomized to receive one of three different doses of LIPO-102. Safety and efficacy were evaluated weekly for 4 weeks and at 1 and 4 weeks post-treatment. Abdominal circumference and skin-fold thickness were measured as a change from baseline.