Neothetics Initiates Study to Evaluate the Safety of LIPO-202 for Body Contouring in Obese Subjects
30 September 2015
SAN DIEGO, Sept. 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 safety study, LIPO-202-CL-21, 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.
"This study highlights the comprehensiveness of our clinical development program that supports our New Drug Application for LIPO-202, which is on track to be filed in the second half of 2016," said Lincoln Krochmal, M.D., Chief Medical Officer for Neothetics. "While we are seeking approval of LIPO-202 for use in non-obese subjects, we recognize the importance of confirming safety in special populations. Consistently our data has shown that LIPO-202 has a safety profile equivalent to placebo."
LIPO-202-CL-21 is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of LIPO-202 in obese subjects (BMI=30 kg/m2 but =40 kg/m2). Approximately 120 subjects will be enrolled and randomized (in a 2:1 ratio) to one of two groups, LIPO-202 or placebo. Subjects will receive a course of treatment, which consists of 20 1-ml subcutaneous injections of LIPO-202 (total weekly dose of 0.40 mcg) once a week for eight weeks. The study is by protocol a safety study to evaluate the safety profile of LIPO-202 in obese subjects. Secondarily, Neothetics will be collecting efficacy data to evaluate the clinical effect of 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 the reduction of subcutaneous fat in the central abdomen in non-obese patients, 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.
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 Form 10-K for the year ended December 31, 2014 and subsequent Quarterly Reports on Form 10-Q.