Neothetics Initiates Pivotal Phase 3 Clinical Trials for LIPO-202, the First Non-Invasive Injectable Drug Candidate for Reduction of Subcutaneous Abdominal Fat

Print 13 Апреля 2015

SAN DIEGO, April 13, 2015 (GLOBE NEWSWIRE) -- Neothetics, Inc. (Nasdaq:NEOT), a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today announced the initiation of two pivotal U.S. Phase 3 trials titled AbCONTOUR1 and AbCONTOUR2 of LIPO-202, the first non-invasive injectable drug candidate for reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects.

"The design of the AbCONTOUR trials is based upon our Phase 2 RESET trial, which showed meaningful and consistent efficacy and safety for LIPO-202 for reducing central abdominal bulging. Past studies also demonstrate LIPO-202 has an excellent safety profile, similar to placebo in nearly 800 subjects treated to date. These factors give us confidence as we start our pivotal Phase 3 trials," said Lincoln Krochmal, M.D., chief medical officer for Neothetics. 

AbCONTOUR1 and AbCONTOUR2 are randomized, double-blind, placebo-controlled Phase 3 trials designed to assess the efficacy, safety, and tolerability of LIPO-202 (total weekly dose of 0.40 mcg for eight weeks) for the reduction of central abdominal bulging. The trials will enroll a total of 1,600 patients to be randomized 1:1 to LIPO-202 or placebo. The trials will be conducted in approximately 80 sites across the U.S.  

The primary efficacy endpoint of both Phase 3 trials is measured using two independent assessment scales: the Patient-Global Abdominal Perception Scale (P-GAPS) and the Clinician Photonumeric Scale (CPnS). These scales were developed and validated by Neothetics and used successfully in the previously reported 513-patient Phase 2 RESET study of LIPO-202. The two assessment scales will be used together as a composite to define a responder as a patient who achieves a two point or greater change on both the P-GAPS and the CPnS.

The secondary endpoints include the reduction in abdominal circumference from baseline using laser-guided manual tape and the subjects' overall satisfaction of the improvement of their appearance as assessed with an Abdominal Contour Questionnaire.

"The initiation of our Phase 3 pivotal AbCONTOUR1 and AbCONTOUR2 trials advances late-stage development of our potentially best-in-class, non-surgical procedure for the reduction of central abdominal bulging. The achievement of this milestone moves Neothetics one step closer to filling a large unmet need for a safe, effective, non-invasive drug treatment for abdominal body contouring," said George Mahaffey, president and CEO of Neothetics.

More information about the Neothetics trials and participating sites is available by visiting www.clinicaltrials.gov and using identifiers NCT02397499 and NCT02398188.

About LIPO-202

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 ofNeothetics, Inc. Other names and brands may be claimed as the property of others.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding Neothetics' plans to research, develop and commercialize LIPO-202 and other product candidates, as well as expected timing for reporting results from clinical trials. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Neothetics' current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with clinical trials and obtaining regulatory approval to commercialize LIPO-202 and other product candidates, product development activities, the need to raise additional funding when needed in order to conduct our business, the degree of market acceptance of LIPO-202 by physicians, patients and others in the medical community, our reliance on third parties, including third party suppliers for manufacturing and distribution of products, regulatory developments in the United States and foreign countries, Neothetics' ability to obtain and maintain intellectual property protection for LIPO-202 and its product candidates, competition in the aesthetics industry and other market conditions. All forward-looking statements contained in this press release speak only as of the date on which they were made. Neothetics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the company files with the SEC available at www.sec.gov, including without limitation Neothetics'Form 10K, dated March 26, 2015.

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