Neothetics Offers Update Related to LIPO-202 Program

Neothetics, Inc.

today provided an update and plan forward for its LIPO-202 program. Neothetics plans to initiate a Phase 2 trial with a modified formulation of LIPO-202 in the third quarter of 2016 for the reduction of central abdominal bulging, which the company anticipates having top-line data from in first quarter of 2017. This Phase 2 study will be a randomized, double-blind, placebo-controlled trial designed to assess the efficacy, safety and tolerability of a modified formulation of LIPO-202. Neothetics also plans to initiate a Phase 2 proof of concept study of LIPO-202 for the reduction of localized fat deposits under the chin (submental fat) in the third quarter of 2016, which the company anticipates having top-line data from by year end 2016. On December 14, 2015, Neothetics announced that LIPO-202 failed to meet its co-primary composite and secondary endpoints in its Phase 3 trials for the reduction of central abdominal bulging. These Phase 3 studies demonstrated near identical results with no bias in sites or subgroups. A detailed review of these unexpected clinical results identified a number of potential opportunities to improve upon the effectiveness of LIPO-202. Neothetics engaged expert consultants to review the results and subsequently develop a modified formulation of LIPO-202 primarily based upon the drug product formulation used in the Phase 2 RESET study. Neothetics believes that it should be able to obtain the positive results observed in the Phase 2 RESET clinical trial with the modified formulation. Following the Phase 3 results, in an effort to reduce expenses the company decreased its headcount from 17 to 9 [full-time] employees. Summary of Phase 3 Data: Studies AbCONTOUR1 and AbCONTOUR2 Studies AbCONTOUR1 and AbCONTOUR2 were randomized double-blind, placebo-controlled studies designed to assess the efficacy, safety and tolerability of LIPO-202 for the reduction of central abdominal bulging compared to placebo injections. The co-primary endpoints were the proportion of subjects who reported an improvement of at least one point on the Patient-Global Abdominal Perception Scale (P-GAPS) and an improvement of at least two points on the Clinician Photonumeric Scale (CPnS) and the proportion of subjects who reported an improvement of at least two points on the P-GAPS and an improvement of at least two points on the CPnS. There were 10 – 13% responders on the one-point P-GAPS and two-point CPnS composite endpoint in both placebo and LIPO-202 treatment groups; there were 3 – 5% responders on the two-point P-GAPS and two-point CPnS composite endpoint in both placebo and LIPO-202 treatment groups. Secondary endpoints included an assessment of changes in abdominal circumference and volume as determined by a laser-guided tape measure procedure. Reductions observed in the circumference at the umbilicus and treatment area volume were the same in both the placebo and LIPO-202 treatment groups. The results of these studies are similar to the results in the placebo groups in the Phase 2 clinical program for LIPO-202 in central abdominal bulging. LIPO-202 continued to show a benign safety profile in these Phase 3 trials. There were no treatment-related serious adverse effects and less than 1% of subjects in each study discontinued due to an adverse event. To receive Neothetics' press releases and other investor information, please go to the Investor Relations page of the company's website at investors.neothetics.com and register for email alerts.