SAN DIEGO, Feb. 9, 2010 (GLOBE NEWSWIRE) -- Lithera, Inc. today announced the successful completion of a three-part Phase I clinical trial of LIPO-102 being developed for the treatment of thyroid-related (Graves' Disease) exophthalmos. LIPO-102 is a novel, minimally-invasive, non-ablative approach to localized fat reduction comprising an injectable aqueous combination of salmeterol xinafoate (SX) and fluticasone propionate (FP). This Phase I clinical study, carried out in abdominal adipose tissue serving as a surrogate for orbital adipose tissue, established the safety and pharmacokinetics of LIPO-102 at maximal doses within the 505(b)(2) threshold for a previously FDA-registered drug product. This trial also provided preliminary evidence of efficacy showing dose-related reductions in waist circumference measurements over the multiple dose part of the trial. A reduction of ~3 cm in mean waist circumference was observed (p=0.014).
"This first clinical study showed that LIPO-102 was well tolerated and produced significant, clinically-meaningful efficacy signals. LIPO-102 may offer a new treatment option for patients with exophthalmos, whose only other option may be surgery," said John Dobak, M.D., Chief Executive Officer of Lithera.
The study consisted of three parts: Part I (n=10) was an open-label, sequential dose escalation study of single doses of SX; Part II (n=8) was an open-label cross-over study to investigate potential interactions between the Selected FP Dose and the Selected SX Dose; and, Part III (n=12) was a single-masked, placebo-controlled multiple-dose study of the Selected SX + FP Combined Dose (LIPO-102) administered once or three times per week for four weeks.
LIPO-102 was well-tolerated with mild, transient injection site reactions being the most frequently experienced treatment-related adverse effect. There was no inflammation, nodularity or skin atrophy on physical examination of the injected sites. No clinically significant changes in mean ECG, laboratory tests or vital signs were identified. Target SX and FP plasma levels were reached with the Selected SX and FP doses. A reduction of ~3 cm in mean waist circumference was observed (p=0.014). There were no significant changes in subject weight.
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 thyroid-related (Graves' Disease) exophthalmos (protrusion of the eye from the orbit).
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 treatment 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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