-Essentialis announced the receipt of a grant from the Foundation for Prader-Willi Research (FPWR) to support clinical study PC025, which is designed to evaluate the safety and efficacy of diazoxide choline controlled release tablets (DCCR) in obese Prader-Willi syndrome patients
-The clinical study is being conducted at the University of California, Irvine under the direction of Dr.Virginia Kimonis.
July 24, 2014
“We have found that the support of FPWR extends well beyond the grant. They have actively promoted this clinical study through their extensive connections in the Prader-Willi community, increasing the pace of recruitment, and they shared the input of experts, improving the design of the clinical study,” said Dr. Neil M. Cowen, President and Chief Scientific Officer of Essentialis.
“FPWR is looking forward to the results of clinical study PC025 and to the further development of DCCR in the treatment of Prader-Willi syndrome where it has the potential to address a significant unmet medical need,” said Dr. Theresa V. Strong, chair of the FPWR Scientific Advisory Board. “This is the first time FPWR has provided funding to a company developing a drug to treat PWS.”
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/.