BOSTON, April 16, 2013 /PRNewswire/ -- Rhythm announced today the initiation of an additional Phase 2 clinical trial for RM-131, the company's novel ghrelin agonist, for the treatment of chronic constipation. Ghrelin is a peptide hormone produced in the stomach that stimulates gastrointestinal motility.
"This is the first of two studies we plan to initiate this year to assess the efficacy and safety of RM-131 for the treatment of lower GI functional disorders," said Elizabeth Stoner, MD, Chief Development Officer of Rhythm. "This initial study will serve as the foundation for developing RM-131 with a priority for treating refractory constipation and potentially irritable bowel syndrome."
This Phase 2 trial is designed to evaluate the effects of RM-131 on symptoms and lower gastrointestinal (GI) function in patients with significant chronic constipation. The trial will assess both the efficacy and safety of RM-131 administered daily for two weeks and is expected to enroll approximately 48 patients. Michael Camilleri, M.D., a gastroenterologist at Mayo Clinic, is the principal investigator for the study.*
Rhythm has completed three Phase 1 clinical trials with RM-131 in both healthy volunteers and patients with Type 1 and Type 2 diabetes, and a Phase 2 clinical trial of RM-131 is currently under way for the treatment of diabetic gastroparesis. The Phase 1 human clinical trials demonstrated potent effects of RM-131 on both upper and lower GI function, increasing both gastric emptying and lower GI transit with good tolerability. In one study conducted in healthy volunteers, multiple daily subcutaneous doses of RM-131 reduced colonic transit time by up to 54%— from approximately 42 hours in placebo subjects to approximately 18 hours (results presented at the American College of Gastroenterology 2012 Annual Scientific Meeting, October 22, 2012).
"Moderate and severe lower GI functional disorders are debilitating and highly prevalent," said Keith Gottesdiener, MD, CEO of Rhythm. "RM-131 has potent prokinetic activity that could improve GI function in patients who are not adequately treated with available therapies. In addition, there is a high incidence of patients with lower GI conditions who also have overlapping upper GI motility disorders, such as Parkinson's disease patients. We are excited about initiating this new Phase 2 study with RM-131 that complements the ongoing Phase 2 study in diabetic gastroparesis."
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. The U.S. Food and Drug Administration (FDA) has granted Fast Track review status to RM-131 for the treatment of diabetic gastroparesis.
About Lower GI Functional Disorders
15 million people in the U.S. seek medial care annually for chronic constipation and irritable bowel syndrome (IBS), and approximately 15% are refractory to existing therapies. These conditions are two of the most common GI motility disorders, with significant health consequences. There is a compelling need for new treatments for lower GI functional disorders, but there are no safe and effective prokinetic drugs currently approved for these conditions in the U.S.
Gastroparesis affects a significant number of the 24 million diabetics in the U.S., with a prevalence of delayed gastric emptying of up to 30% among Type 1 and Type 2 diabetics. Gastroparesis symptoms include chronic nausea, vomiting, and malnutrition and results in a significant rate of hospitalization. This condition also often undermines measures to manage hyperglycemia.
* Dr. Camilleri has research funded by Rhythm to study RM-131. He also serves on the company's Scientific Advisory Board. He receives no personal financial compensation from Rhythm.
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.