Neothetics, a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, has initiated the safety study, LIPO-202-CL-21, of LIPO-202, the first noninvasive injectable drug candidate for reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects. This is a supplemental safety study that Neothetics expects to submit to the FDA as part of the company’s NDA package for LIPO-202, which the company anticipates filing in the second half of 2016.
“This study highlights the comprehensiveness of our clinical development program that supports our NDA for LIPO-202, which is on track to be filed in the second half of 2016,” said Lincoln Krochmal, M.D., chief medical officer for Neothetics. “While we are seeking approval of LIPO-202 for use in non-obese subjects, we recognize the importance of confirming safety in special populations. Consistently our data has shown that LIPO-202 has a safety profile equivalent to placebo."
LIPO-202-CL-21 is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of LIPO-202 in obese subjects (BMI=30 kg/m2 but =40 kg/m2). About 120 subjects will be enrolled and randomized (in a 2:1 ratio) to one of two groups, LIPO-202 or placebo. Subjects will receive a course of treatment, which consists of 20 1-ml subcutaneous injections of LIPO-202 (total weekly dose of 0.40 mcg) once a week for eight weeks. The study is by protocol a safety study to evaluate the safety profile of LIPO-202 in obese subjects. Secondarily, Neothetics will collect efficacy data to evaluate the clinical effect of LIPO-202.