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.
LIPO-102 was well-tolerated when administered into subcutaneous abdominal fat; the most commonly reported adverse events were mild, transient injection site pain (20%) and irritation (15%), most of which resolved spontaneously within five minutes. There was no inflammation, nodularity or skin atrophy observed on physical examination of the injected sites. There were also no clinically significant changes in blood pressure, heart rate, respiratory rate or temperature measurements. LIPO-102 was associated with reductions in abdominal circumference when administered once weekly with the greatest change occurring at Week 8 (4 weeks post-treatment). The optimal dose produced reductions in abdominal circumference of 2.93 cm (p = 0.086) at Week 5 and 3.47 cm (p = 0.017) at Week 8. LIPO-102 was also associated with reductions in abdominal skin-fold thickness. The greatest reductions in abdominal skin-fold thickness (-3.21 mm, p < 0.001) were also observed at Week 8. No change in mean subject weight was observed over the 8-week trial.