Neothetics Initiates Study to Evaluate the Post-Treatment Safety and Duration of Clinical Effect of LIPO-202 for Body Contouring

Neothetics, Inc.

, a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today announced the initiation of the post-treatment safety and duration of effect study, LIPO-202-CL-23, of LIPO-202, the first non-invasive 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 U.S. Food and Drug Administration (FDA) as part of the company's New Drug Application (NDA) package for LIPO-202, which the Company anticipates filing in the second half of 2016. "The achievement of this milestone highlights the traction of our Phase 3 Pivotal Program, AbCONTOUR1 and AbCONTOUR2," said Lincoln Krochmal, M.D., Chief Medical Officer for Neothetics. "We are committed to develop LIPO-202 as the first non-invasive drug treatment for abdominal body contouring." LIPO-202-CL-23 is a double-blind extension study to evaluate the post-treatment safety and duration of clinical effect of LIPO-202 in subjects who have completed either AbCONTOUR1 (LIPO-202-CL-18) or AbCONTOUR2 (LIPO-202-CL-19). The study is by protocol a safety study to evaluate the post-treatment safety profile of LIPO-202 for up to one year post-treatment. Secondarily, Neothetics will be evaluating post-treatment duration of clinical effect of LIPO-202. Subjects will be evaluated up to one year at three, six, nine, and twelve month intervals from baseline (last visit of the parent study AbCONTOUR1 and AbCONTOUR2). All study subjects will be evaluated at three months for safety and duration of effect of LIPO-202. Only subjects with a clinically meaningful response, defined as a reduction of at least a 1-point change on the Patient-Global Abdominal Perception scale (P-GAPS) at the last visit of the parent study will continue to be evaluated at six, nine, and twelve months. More information about the Neothetics trials and participating sites is available by visiting www.clinicaltrials.gov and using identifiers NCT02397499 and NCT02398188.