Rhythm Announces Phase 1b Results for Ghrelin Prokinetic
RM-131 for Diabetic Gastroparesis
BOSTON, May 22, 2012—
Rhythm announced today the results of a Phase 1b clinical trial of RM-131, the company's novel ghrelin agonist for the treatment of diabetic gastroparesis. The trial demonstrated that RM-131 greatly accelerates gastric emptying in patients with diabetic gastroparesis. The findings were presented at the Digestive Disease Week 2012 conference in San Diego.
The Phase 1b clinical trial was a randomized, double-blind, placebo-controlled, single-dose crossover study in 10 patients with type 2 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 patients with diabetic gastroparesis. The trial also assessed safety and tolerability.
In the poster, "Randomized, Placebo-Controlled, Single-Dose, Crossover Study of the Effects of RM-131 in Type 2 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 accelerating gastric emptying in patients with type 2 diabetes and delayed gastric emptying.
- Gastric emptying time was reduced by 66%.
- The greatest improvement was observed in patients with the most abnormal gastric emptying.
- RM-131 was generally well tolerated, with no serious adverse events.
- RM-131 was successfully designed to retain the pharmacodynamic properties of human ghrelin at lower and less frequent doses.
"We want to thank the Mayo Clinic for running this excellent clinical study," said Keith Gottesdiener, MD, CEO of Rhythm. "There is a great need for new treatments for diabetic gastroparesis, which afflicts patients with debilitating symptoms and causes frequent hospitalizations. These RM-131 results are encouraging and serve as the foundation for further clinical trials with RM-131 for the treatment of gastroparesis and other 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.
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, malnutrition, and results in a significant rate of hospitalization. This condition also often undermines measures to manage hyperglycemia.