SAN DIEGO, May 5, 2010 (GLOBE NEWSWIRE) -- 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 was well-tolerated when administered weekly for 8 weeks into the subcutaneous abdominal fat of healthy subjects. LIPO-102 injections in the anterior abdomen produced dose- and time-related reductions in mean abdominal circumference and volume of -1.2 cm (versus -0.1 cm for placebo; p=0.048) and -183 cc (versus +24 cm for placebo; p=0.023), respectively, using 3-D photographic imaging. Consistent with the pharmacology of LIPO-102 and known changes in lipolytic sensitivity with age, younger and thinner patients demonstrated even larger mean reductions in abdominal volume and circumference (-360 cc and -2.2 cm, respectively). The effects of the optimal dose of LIPO-102 (1 mcg SX + 22 mcg FP) on abdominal circumference and volume persisted for 6 to 12 weeks post-treatment.
"Meaningful clinical changes in abdominal circumference have now been observed with LIPO-102 in 3 consecutive studies, including the most recent randomized, placebo-controlled, double-blind study," said John Dobak, M.D., Chief Executive Officer of Lithera. "The data from these clinical trials have helped us optimize dose parameters for the treatment of abdominal adiposity and symptomatic exophthalmos."
Sixty healthy adult, male and female subjects aged 18-65 with a body mass index (BMI) greater than or equal to 18.5 kg/m2 and <28 kg/m2 were enrolled in this double-blind, placebo-controlled study. Subjects were randomized to receive injections of placebo or one of two different doses of LIPO-102 into their anterior abdomen once weekly for 8 weeks. Safety and efficacy were evaluated weekly for 8 weeks and at 1, 6 and 12 weeks post-treatment. Abdominal circumference and volume were measured as a change from baseline using a 3-D photographic imaging system.
LIPO-102 was well-tolerated when administered into subcutaneous abdominal fat; there were no systemic effects of note, and locally there was no inflammation, nodularity or skin atrophy observed on physical examination of the injected sites. LIPO-102 was associated with reductions in abdominal circumference and volume when administered once weekly for 8 weeks with positive results seen in some individuals after 4 weeks of treatment and with the greatest changes observed at 1 and 6 weeks post-treatment. The mean reductions in abdominal volume that were observed in younger subjects with LIPO-102 (1 mcg SX + 22 mcg FP) at week 9 (-360 cc; p=0.004) are similar in magnitude to those observed with limited area liposuction.
About LIPO-102
LIPO-102 is being developed as a first-in-class injectable drug product designed to produce local, selective fat tissue reduction (pharmaceutical lipoplasty). Using FDA-registered drugs approved for use in other indications, LIPO-102 targets and stimulates natural fat tissue metabolism to achieve non-ablative, non-surgical fat tissue reduction in specific locations. LIPO-102 is currently under development for the treatment of symptomatic exophthalmos (protrusion of the eye from the orbit) associated with thyroid-related eye disease (the thyroid condition is also known as Graves' Disease) and the reduction of abdominal adiposity.
About Lithera
Lithera is a clinical stage company developing pharmaceutical and biomedical products addressing both medical and lifestyle indications in ophthalmology and aesthetic medicine. Our lead product candidate (LIPO-102) is a novel injectable pharmaceutical product designed to produce local, selective fat tissue reduction (pharmaceutical lipoplasty). Founded in 2007, the Company has assembled an exceptional team of senior executives, employees and advisors and has been financed by top-tier venture capital firms. For more information on Lithera, Inc., please visit www.lithera.com.
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