Rhythm Announces Phase 1b Results for Ghrelin Prokinetic RM-131 for Gastroparesis in Patients with Type 1 Diabetes
BOSTON, May 20, 2013 /PRNewswire/ -- Rhythm announced today the results of a second Phase 1b clinical trial of RM-131, the company's novel ghrelin agonist for the treatment of diabetic gastroparesis in type 1 diabetic patients. The trial demonstrated that RM-131 significantly accelerates early gastric emptying and reduces upper gastrointestinal (GI) symptoms in type 1 diabetic patients with diabetic gastroparesis. The findings were presented at the Digestive Disease Week 2013 conference in Orlando and recently published in Clinical Gastroenterology and Hepatology.
The Phase 1b clinical trial was a randomized, double-blind, placebo-controlled, single-dose, two-period crossover study in 10 patients with type 1 diabetes, a history and symptoms of diabetic gastroparesis, and documentation of delayed gastric emptying. The primary objective of the study was to evaluate the pharmacodynamic profile of RM-131 administered as a single dose (100 mcg) to type 1 diabetic patients with diabetic gastroparesis. The trial also assessed safety and tolerability.
In the poster, "Phase 1, Randomized, Placebo-Controlled, Single-Dose, Two-Period, Crossover Study of RM-131 on Pharmacodynamics and Symptoms in Type 1 Diabetics with Documented Delayed Gastric Emptying," Andrea Shin, M.D., a Mayo Clinic gastroenterology Fellow and study author, presented the following clinical data:
- RM-131 is effective in significantly accelerating early gastric emptying in patients with type 1 diabetes and delayed gastric emptying
- Median gastric emptying half-time was reduced by ~55%
- GI symptoms were significantly reduced
- RM-131 was generally well tolerated, with no serious adverse events
"This study expands on the previous findings of the Mayo Clinic research team that RM-131 significantly accelerated gastric emptying in gastroparesis patients with type 2 diabetes by 66%," said Keith Gottesdiener, MD, CEO of Rhythm. "These data are support for the ongoing Phase 2 clinical trial of RM-131 for the treatment of gastroparesis in both type 1 and type 2 diabetic patients. We wish to thank the Mayo Clinic research team headed by Dr. Michael Camilleri for running this excellent study."
RM-131 is in Phase 2 clinical trials for the treatment of diabetic gastroparesis and lower GI functional disorders. 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.
Gastroparesis affects a significant number of the 24 million diabetics in the U.S; there are 2.3 million type 1 and type 2 diabetic patients with moderate or severe gastroparesis symptoms who are seeking treatment. 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.
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.