Rhythm Initiates Phase 2 Clinical Trial of Ghrelin Prokinetic
RM-131 for Diabetic Gastroparesis
BOSTON, June 6, 2012— Rhythm announced today the initiation of a Phase 2 clinical trial for RM-131, the company's novel ghrelin agonist, for the treatment of gastroparesis in patients with Type I and Type II diabetes. Ghrelin is a peptide hormone produced in the stomach that stimulates gastric motility.
"We are excited about the clinical profile of RM-131 as we bring it forward into Phase 2 development," said Liz Stoner, MD, Chief Development Officer of Rhythm. "Extensive preclinical and early clinical studies demonstrate RM-131's therapeutic potential for restoring gastric function in diabetics and other patients with impaired GI motility. This Phase 2 study will expand our understanding of RM-131's profile for treating diabetic patients with both moderate and severe gastroparesis."
The Phase 2 trial is designed to evaluate the effect of RM-131 on GI motility, the symptoms of gastroparesis, and safety in patients with diabetic gastroparesis. The trial will assess dosing regimens from 10 to 100 mcg administered for one month. The trial is expected to enroll approximately 125 patients.
In 2011, Rhythm completed three Phase 1 clinical trials with RM-131 in both healthy volunteers and patients with Type II diabetes, supporting selection of the dosing regimens for the Phase 2 study. RM-131 had a highly potent prokinetic effect on gastric emptying in each of these studies and was generally well tolerated.
"Diabetic gastroparesis is a disease with significant consequences. This condition interferes with nutrition and glucose control, erodes quality of life, and results in frequent hospitalization. It is a serious unmet medical need," said Keith Gottesdiener, MD, CEO of Rhythm. "RM-131's prokinetic activity has the potential to restore GI function in these patients and to become an important new treatment for GI functional disorders resulting from diabetes, and for other related GI conditions."
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.