Neothetics Initiates Study to Evaluate Safety of Retreatment With LIPO-202 for Body Contouring
23 March 2015
SAN DIEGO, March 23, 2015 (GLOBE NEWSWIRE) -- Neothetics, Inc. (Nasdaq:NEOT), a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today announced it has initiated an open-label study to evaluate the safety of multiple courses of treatment of LIPO-202 (salmeterol xinafoate for injection) for the reduction of central abdominal bulging. This is a supplemental study thatNeothetics 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.
The open-label, study – referred to as LIPO-202-CL-22 – will consist of three, eight-week courses of treatment with LIPO-202 with a three month period between treatments in non-obese adult subjects who have central abdominal bulging. Each course of treatment consists of 20 subcutaneous one mL injections of LIPO-202 (0.02 mcg salmeterol xinafoate/mL; total dose of 0.40 mcg salmeterol xinafoate), administered once a week. The study utilizes the same dose of drug to be used in Neothetics' pivotal Phase 3 safety and efficacy trials. Neothetics expects to enroll 150 subjects at multiple centers in the U.S.
"LIPO-202 has demonstrated an extremely clean safety profile, equivalent to placebo in the six clinical trials conducted to date, and this study will give us insights about the safety of multiple courses of treatment," said George Mahaffey, president and chief executive officer of Neothetics. "We look forward to continuing our program development with future clinical trials."
More information about the Neothetics study is available by visiting www.clinicaltrials.gov.
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 S-1, dated October 17, 2014, as amended.