Neothetics, Inc. (NEOT)

[snidely]

Neothetics Initiates Phase 2 Proof of Concept Trial for LIPO-202 for the Reduction of Submental Subcutaneous Fat

GlobeNewswire•December 23, 2016
SAN DIEGO, Dec. 23, 2016 (GLOBE NEWSWIRE) -- Neothetics, Inc. (NEOT) today announced the initiation of the Phase 2 proof of concept trial, LIPO-202-CL-31, for LIPO-202 for the reduction of submental subcutaneous fat.
“The initiation of our Phase 2 proof of concept trial for LIPO-202 for the reduction of submental fat is a significant milestone for Neothetics,” said Kim Kamdar, Ph.D., a member of Neothetics’ Operating Committee and Board of Directors. “We continue to believe LIPO-202 could have exceptional impact in the submental fat reduction market.”

LIPO-202-CL-31 is a multi-center, randomized, double-blind, placebo-controlled Phase 2 proof of concept trial to assess the safety and efficacy of two doses of LIPO-202 versus placebo for the reduction of submental bulging due to subcutaneous fat. The trial is expected to enroll a total of 150 patients at approximately ten sites across the United States. Subjects will receive up to 30 subcutaneous injections of LIPO-202 or placebo once a week for eight weeks. Subjects will be randomized 1:1:1 and receive either 0.3 mcg, or 3.0 mcg dose of LIPO-202, or placebo. Follow up visits to access safety and efficacy will occur one week and four weeks post the last treatment.
The study endpoints include both safety and efficacy measurements. Efficacy measures will assess improvement in the patient’s submental region as evaluated by both the patient and clinician, overall patient satisfaction and evaluation of submental fat thickness by calipers.
The company expects to report top-line data from this trial in late second quarter 2017.
More information about the Neothetics trials and participating sites is available by visiting www.clinicaltrials.gov.