Lithera Concludes LIPO-102 Phase I Trial

LIPO-102 is a new, minimally-invasive, non-ablative approach to localised fat reduction comprising an injectable aqueous combination of salmeterol xinafoate (SX) and fluticasone propionate (FP).

Reportedly, the 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) threshold for a previously FDA-registered drug product.

The trial has 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 ~3cm in mean waist circumference was observed.

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.

However, 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.

The study showed that LIPO-102 was well-tolerated with mild, transient injection site reactions being the most frequently experienced treatment-related adverse effect. Target SX and FP plasma levels were reached with the Selected SX and FP doses. A reduction of ~3cm in mean waist circumference was observed (p=0.014). There were no significant changes in subject weight.

John Dobak, CEO of Lithera, said: “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.”