Print 23 December 2016
"The initiation of our Phase 2 proof of concept trial for LIPO-202 for the reduction of submental fat is a significant milestone for Neothetics," said
LIPO-202-CL-31 is a multi-center, randomized, double-blind, placebo-controlled Phase 2 proof of concept trial to assess the safety and efficacy of two doses of LIPO-202 versus placebo for the reduction of submental bulging due to subcutaneous fat. The trial is expected to enroll a total of 150 patients at approximately ten sites across the United States. Subjects will receive up to 30 subcutaneous injections of LIPO-202 or placebo once a week for eight weeks. Subjects will be randomized 1:1:1 and receive either 0.3 mcg, or 3.0 mcg dose of LIPO-202, or placebo. Follow up visits to access safety and efficacy will occur one week and four weeks post the last treatment.
The study endpoints include both safety and efficacy measurements. Efficacy measures will assess improvement in the patient's submental region as evaluated by both the patient and clinician, overall patient satisfaction and evaluation of submental fat thickness by calipers.
The company expects to report top-line data from this trial in late second quarter 2017.
More information about the Neothetics trials and participating sites is available by visiting www.clinicaltrials.gov.
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. LIPO-202 is designed to be a locally-injected drug that causes localized shrinking of fat cells without any effect on nearby tissues. LIPO-202 activates ß2-adrenergic receptors on fat cells, triggering the metabolism of triglycerides stored in the fat cells, and thereby shrinking them across the treatment area.
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 the ability to develop a modified formulation of LIPO-202, timing of conducting and obtaining results from Phase 2 trials and proof of concept study with a modified formulation of LIPO-202, whether our modified formulation of LIPO-202 is able to demonstrate positive results, Neothetics' plans to research, develop and commercialize LIPO-202 and other product candidates, our expectations regarding the potential market size and opportunity of LIPO-202, 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, such as the ability to timely initiate clinical trials and enroll a sufficient number of patients on a timely basis into clinical trials, the extent to which top-line data is available and whether the clinical trials achieve positive results, product development activities, obtaining regulatory approval to commercialize LIPO-202 and other product candidates, Neothetics' use of cash and the need to raise additional funding, when needed, in order to conduct our clinical trials and other 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 10-K for the year ended December 31, 2015 and subsequent Quarterly Reports on Form 10-Q.
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