Print 13 April 2015
"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
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
LIPO-202 is an injectable formulation of salmeterol xinafoate, a well-known long-acting ß2-adrenergic receptor agonist used in several
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
Russian pharmaceutical company NovaMedica, a portfolio company of RUSNANO, announces the start of construction of a plant for the production of sterile injectable drugs as part of its long-term strategy to localize innovative medicines and technologies of their development and production in Russia. The plant will be built in the industrial park “Vorsino” in the Kaluga region.
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