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news.Essentialis has 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.
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The clinical study is being conducted at the University of California, Irvine under the direction of Dr. Virginia Kimonis.
"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."
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.