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- Rhythm initiating Phase 2 clinical trial of ghrelin prokinetic RM-131 -
BOSTON, Sept. 10, 2013 /PRNewswire/ -- Rhythm announced today that The Michael J. Fox Foundation for Parkinson's Research (MJFF) has awarded a $1.35 million research grant to Rhythm to help fund a Phase 2 clinical trial of RM-131, the company's novel ghrelin agonist, for the treatment of refractory constipation in patients with Parkinson's disease (PD). This study expands the ongoing Phase 2 clinical program for RM-131 for the treatment of both upper and lower gastrointestinal (GI) functional disorders.
"As we work toward a cure for Parkinson's, alleviating the symptoms of disease is our best approach to improve quality of life for the millions living with PD. Development of a treatment for painful and debilitating constipation will have significant meaning to this population," said Maurizio Facheris, MD, MJFF associate director of research programs.
Constipation is common among people with Parkinson's, with studies reporting more than 50% of PD patients suffering from moderate to severe constipation. Many of these patients are refractory to existing therapy. In addition, GI dysfunction in PD can affect the upper GI tract, resulting in gastroparesis. Overall, the symptoms of upper and lower GI functional disorders can be debilitating and disruptive to the lives of PD patients and, in addition, may undermine the GI absorption of L-DOPA in the intestine, interfering with this drug's effectiveness. Approximately one million people in the U.S. are living with Parkinson's disease.
"Refractory constipation is a significant issue in Parkinson's disease, and this first study of RM-131 in Parkinson's patients is focused on this disorder," said Keith Gottesdiener, MD, CEO of Rhythm. "As we continue our work to advance RM-131 in the clinic, we are excited to join with The Michael J. Fox Foundation to address this important unmet need in Parkinson's disease."
About the Study
The Phase 2 trial, "MOVE-PD," is designed to evaluate the effects of RM-131 on symptoms and lower gastrointestinal (GI) function in Parkinson's Disease (PD) patients with chronic constipation who are refractory to current treatment. The trial will assess both the efficacy and safety of RM-131 administered daily for two weeks and is expected to enroll approximately 56 patients. Rhythm is conducting the MOVE-PD study in partnership with the Parkinson's Study Group and Ronald Pfeiffer, MD, University of Tennessee, the study's principal investigator.
RM-131 is a small-peptide analog of ghrelin, a hormone produced in the stomach that stimulates gastrointestinal activity. Derived from the natural ghrelin sequence, RM-131 has been optimized to stimulate gastrointestinal motility, with greater potency and enhanced stability and pharmacokinetics. In Phase 1 clinical trials, RM-131 was effective in accelerating both gastric emptying and colonic transit and was shown to be safe and well-tolerated. RM-131 is currently in Phase 2 clinical trials for the treatment of diabetic gastroparesis and lower GI functional disorders. The U.S. Food and Drug Administration (FDA) has granted Fast Track review status to RM-131 for the treatment of diabetic gastroparesis.
About The Michael J. Fox Foundation for Parkinson's Research
As the world's largest private funder of Parkinson's research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson's disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson's patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $350 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson's research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson's disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson's awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world.
About the Parkinson Study Group
The not-for-profit PSG is the largest and oldest network of Parkinson's disease clinical trial sites and their credentialed investigators (movement disorders physicians) and clinical coordinators, with 132 clinical sites across the United States, Canada and the Caribbean. Since 1986, the PSG has partnered with industry, government and philanthropic institutions to conduct over 40 PD clinical studies, enrolling over 7,000 subjects and contributing to regulatory approval of 4 antiparkinsonian therapeutics. The PSG is based at the Massachusetts General Hospital in Boston, Massachusetts.
About Rhythm (www.rhythmtx.com)
Rhythm is a biotechnology company developing peptide therapeutics that address unmet needs in metabolic diseases. Rhythm is developing the ghrelin peptide agonist, RM-131, for the treatment of diabetic gastroparesis and other GI functional disorders; and the MC4R peptide agonist, RM-493, for obesity and diabetes. Rhythm investors include MPM Capital, New Enterprise Associates, Third Rock Ventures, Ipsen, and Pfizer Ventures. The company is based in Boston, Massachusetts.
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