Rensselaer, New York., March 11, 2019 (GLOBE NEWSWIRE) -- ConSynance Therapeutics, Inc., a clinical-stage biotechnology company developing two innovative treatments for Prader-Willi Syndrome (PWS), today announced that they joined the PWS Clinical Trial Consortium.

The PWS Clinical Trial Consortium (https://www.pwsctc.org/) was established to accelerate clinical trials to address unmet needs for PWS by leveraging the expertise and perspective of industry, academia, patient organizations and regulatory agencies. The consortium is supporting the development of endpoints to measure the benefits of treatments against hyperphagia and behavioral challenges in PWS and was recently granted a Critical Path Innovation Meeting with the FDA.

“We are delighted to participate in the PWS Clinical Trial Consortium and to extend best practices for clinical development of our therapeutics to treat individuals suffering from PWS,” said Peter Guzzo, PhD, Chief Executive Officer of ConSynance.

PWS is a rare, genetic condition that is characterized by hyperphagia (insatiable appetite), which can lead to obesity and related metabolic comorbidities. Individuals with PWS also typically suffer from behavioral problems such as anxiety, compulsivity and cognitive disabilities. Currently, there is no cure for PWS and no treatment for some of the most difficult aspects of the syndrome, such as the hyperphagia and other behavioral aspects of the disorder.

ConSynance has two distinct candidates for the treatment of hyperphagia and other behavioral aspects of PWS: CSTI-100 (a melanin-concentrating hormone receptor 1 antagonist) and CSTI-500 (a triple monoamine reuptake inhibitor).

CSTI-100’s pharmacological profile is expected to treat the core symptoms of PWS, mainly: hyperphagia, obesity, anxiety, and day time sleepiness. In phase I clinical studies, healthy, overweight volunteers had up to a 47% suppression of hunger on a visual analog scale after 14 days of oral dosing suggesting the potential to treat hyperphagia in PWS patients.

The appropriately balanced triple monoamine reuptake inhibitor, CSTI-500, is anticipated to address the hallmark symptoms of PWS, particularly the hyperphagia, obesity, and multiple behavioral issues such as social isolation, obsessive-compulsive disorder, cognitive disabilities, and excessive daytime sleepiness. In phase I studies with CSTI-500, a long half-life (44-50 hours) after oral administration and weight loss was observed which we believe is a relevant signal for treatment of PWS.

About ConSynance Therapeutics, Inc.

ConSynance Therapeutics is a clinical-stage drug development company based in Rensselaer, New York. ConSynance’s pipeline includes innovative treatments for the orphan disease Prader-Willi syndrome, nonalcoholic steatohepatitis, and irritable bowel syndrome. www.consynance.com

About Foundation for Prader-Willi Research (FPWR)

FPWR is composed of thousands of parents, family members, researchers, and others who are interested in addressing the many issues related to PWS, including childhood obesity, developmental delays, psychiatric disorders, and autism spectrum disorders. The mission of FPWR is to eliminate the challenges of Prader-Willi syndrome through the advancement of research and therapeutic development. FPWR supports cutting edge research studies around the world to advance the understanding of PWS, and collaborates with research institutions, pharmaceutical companies and the FDA to advance new treatments that will help those with PWS. To date, FPWR has funded over $12 million in PWS research. For more information please visit https://www.fpwr.org/.

ConSynance Therapeutics, Inc. Forward-Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1996 regarding the research, development and commercialization of pharmaceutical and/or bio-technology products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that any treatments in the company’s pipeline, will receive regulatory approval for the indications described herein. ConSynance Therapeutics, Inc. undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact
Shuang Liu, Ph.D.
President, ConSynance Therapeutics, Inc.
518-275-0176
shuang@consynance.com