Neothetics Announces Last Subject Enrolled in Phase II Trial
Neothetics, Inc. recently announced completion of subject enrollment for its Phase II proof-of-concept trial, LIPO-202-CL-31, for the reduction of submental subcutaneous fat.
“We are excited to announce the conclusion of enrollment in our first trial with LIPO-202 for the reduction of submental fat. We are encouraged by the strong investigator interest and rapid subject enrollment,” said Kim Kamdar, PhD, a member of Neothetics’ Operating Committee and Board of Directors. “This is a robust clinical trial design based on both our significant experience with LIPO-202 and extensive feedback from key opinion leaders and investigators on submental fat reduction.”
LIPO-202-CL-31 is a multi-center, randomized, double-blind, placebo-controlled Phase II proof-of-concept trial to evaluate the safety and efficacy of two doses of LIPO-202 versus placebo for the reduction of submental bulging due to subcutaneous fat. The trial has enrolled approximately 150 subjects at 12 sites across the US. Subjects will be randomized 1:1:1 and receive up to either 0.3 mcg, or 3.0 mcg dose of LIPO-202, or placebo. Subjects will receive up to 30 subcutaneous injections of LIPO-202 or placebo once a week for 8 weeks and follow up visits to assess safety and efficacy will occur 1 week and 4 weeks post the last treatment.
The study endpoints include both safety and efficacy measurements. Efficacy measures will assess improvement in the subject’s submental region as evaluated by both the patient and clinician, covering overall subject satisfaction and evaluation of submental fat thickness by calipers. The company expects to report top-line data in June 2017.
LIPO-202 is a proprietary, first-in-class injectable formulation of the well-known long-acting ß2-adrenergic receptor agonist, salmeterol xinafoate, which is an active ingredient of FDA-approved inhaled products such as SEREVENT DISKUS, ADVAIR HFA, and ADVAIR DISKUS. Our studies suggest that salmeterol xinafoate activates ß2 -adrenergic receptors on fat cells, triggering the body’s natural process of metabolizing stored triglycerides (fat) resulting in a reduction in size and volume of the fat cells in the treatment area without damage of nearby tissues. LIPO-202 has an extremely favorable safety profile, with little to no adverse post treatment effects. LIPO-202 is being evaluated for the reduction of submental fat commonly referred to as a double-chin.
Neothetics is a San Diego-based clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market. Our initial focus is on localized fat reduction and body contouring. Our lead product candidate, LIPO-202, is a first-in-class injectable formulation of the long-acting ß2-adrenergic receptor agonist, salmeterol xinafoate, which is an active ingredient in the US FDA approved inhaled products SEREVENT DISKUS, ADVAIR HFA, and ADVAIR DISKUS. For more information, visit www.neothetics.com.
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