SAN DIEGO, June 30, 2015 (GLOBE NEWSWIRE) -- Neothetics, Inc. (Nasdaq:NEOT), 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.
LIPO-202 is an injectable formulation of salmeterol xinafoate, a well-known long-acting ß2-adrenergic receptor agonist used in several FDA-approved drugs, including ADVAIR® for asthma. Neothetics' studies suggest that salmeterol xinafoate also activates ß2-adrenergic receptors on fat cells, triggering the breakdown of triglycerides stored in the cells, causing them to shrink by means of a natural process called lipolysis. LIPO-202 is being developed as a non-surgical, convenient method to reduce non-obese individuals' central abdominal bulging due to subcutaneous fat – commonly characterized as a pot-belly, stomach rolls, or a pouch.
About Neothetics, Inc.
Neothetics is a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market. The lead product candidate, LIPO-202, is for central abdominal bulging due to subcutaneous fat in non-obese subjects, an indication for which there is no FDA-approved drug. If approved, LIPO-202 may be a best-in-class non-surgical, non-ablative procedure and first-in-class injectable formulation for localized fat reduction and body contouring. For more information on Neothetics, please visit www.neothetics.com.
Neothetics, LIPO-202, LIPO-102 and the Neothetics' logo are trademarks or registered trademarks of Neothetics, Inc. Other names and brands may be claimed as the property of others.
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