Rhythm announced today the results of two Phase 1 clinical trials of RM-131, the company's novel ghrelin agonist for the treatment of diabetic gastroparesis, which demonstrated that RM-131 greatly accelerates gastric emptying in healthy subjects with good tolerability. The findings were presented at the American College of Gastroenterology 2012 Annual Scientific Meeting (ACG 2012) in Las Vegas on October 22, 2012. In addition, Rhythm announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track review status to RM-131 for the treatment of diabetic gastroparesis.
The presentation at ACG 2012 highlights RM-131's strong prokinetic activity in both single- and multiple-dose studies and its potential as a pan-gastrointestinal (GI) prokinetic for the treatment of upper and lower GI functional disorders, including diabetic gastroparesis. Clinical highlights include:
RM-131 was shown to be effective in accelerating gastric emptying in healthy volunteers. After single daily subcutaneous administration of RM-131, gastric emptying time was significantly reduced by up to 55% in the single ascending dose study, and by up to 50% in the multiple ascending dose study.
RM-131 was shown to be effective in accelerating lower colonic motility in healthy volunteers. After multiple daily subcutaneous doses of RM-131, colonic transit time was reduced by up to 54% (from ~42 hours in placebo subjects to ~18 hours).
RM-131 was generally well tolerated, with no serious adverse events.
"These studies demonstrate substantial prokinetic effects of RM-131 on both gastric emptying and lower GI transit," said Lee M. Kaplan, MD, PhD, Associate Professor of Medicine at Harvard Medical School, Director of the Obesity, Metabolism, & Nutrition Institute at the Massachusetts General Hospital, and an author on the study. "Defects in gastric emptying underlie several functional GI disorders, including gastroparesis. Our treatment options for these common and debilitating diseases are currently very limited."