Rhythm has commenced a Phase 2 trial of RM-131 to treat gastroparesis in patients with Type 1 and Type 2 diabetes.
RM-131 is a small-peptide analogue of ghrelin, a hormone produced in the stomach that stimulates gastrointestinal activity.
The trial is designed to evaluate the effect of RM-131 on GI motility, the symptoms of gastroparesis and safety in patients with diabetic gastroparesis.
Rhythm chief development officer, Elizabeth Stoner, said 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," Stoner added.
The Phase 2 trial, which expects to enrol approximately 125 patients, will assess dosing regimens from 10mcg to 100mcg administered for one month.
The company conducted three Phase 1 clinical trials with RM-131 in both healthy volunteers and patients with Type 2 diabetes in 2011, supporting the selection of the dosing regimens for the Phase 2 study.
The studies demonstrated a potent prokinetic effect of RM-131 on gastric emptying and the ghrelin agonist was generally well tolerated.
Rhythm CEO Keith Gottesdiener said that diabetic gastroparesis interferes with nutrition and glucose control, erodes quality of life and results in frequent hospitalisation.
"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," Gottesdiener added.