CARLSBAD, Calif., Nov. 14, 2014 /PRNewswire/ -- Essentialis announced today that Dr. Neil M. Cowen, President and Chief Scientific Officer, will be presenting a summary of interim results of clinical study PC025 on November 16, 2014 at the Annual Research Conference of the Foundation for Prader-Willi Research. Clinical study PC025 is designed to evaluate the safety and efficacy of diazoxide choline controlled release tablets (DCCR) in obese Prader-Willi syndrome (PWS) patients. The clinical study is being conducted at the University of California, Irvine under the direction of Dr. Virginia Kimonis.
“We are looking forward to sharing the interim results from this study with PWS parents and researchers at the FPWR Annual Research Conference. The results from the open-label phase of this randomized withdrawal study are very encouraging including statistically significant reductions in hyperphagia, favorable impacts on body composition and increases in energy expenditure,” said Dr. Cowen. “FPWR has generously supported us in the conduct of this study.”
About DCCR DCCR is a proprietary crystalline salt of diazoxide formulated as a controlled-release, once-a-day tablet. It is in development for the treatment of Prader-Willi syndrome and hypothalamic obesity. DCCR is covered by multiple issued US and granted EU and Japanese patents, which provide composition of matter protection until 2028. Essentialis is globally prosecuting claims to the use of pharmaceutical formulations of KATP channel activators including diazoxide and DCCR in the treatment of Prader-Willi syndrome. Essentialis has evaluated DCCR in more than 200 subjects in multiple double-blind, placebo-controlled studies. More information about clinical study PC025 can be found at www.clinicaltrials.gov using identifier NCT02034071.
About FPWR The Foundation for Prader-Willi Research was established in 2003 by a small group of parents who saw the need to foster research that would help their children with Prader-Willi syndrome lead more healthy and fulfilling lives. Today, FPWR is composed of hundreds of parents, family members, researchers, and others who are interested in addressing the many issues related to PWS, including childhood obesity, developmental delay, psychiatric disorders, and autism spectrum disorders. The mission of FPWR is to eliminate the challenges of Prader-Willi syndrome through the advancement of research. For more information visit http://www.fpwr.org/.
About Essentialis, Inc. Essentialis is a Carlsbad-based, orphan drug focused, pharmaceutical company focused on the development of breakthrough medicines targeted to the ATP-sensitive potassium channel, a metabolically regulated membrane protein whose modulation has the potential to treat and prevent a wide range of metabolic, CNS and cardiovascular diseases.
For more information visit. http://essentialistherapeutics.com/.
SOURCE Essentialis, Inc.
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