Rhythm, a biotechnology company developing peptide therapeutics that address unmet needs in metabolic diseases, initiated an additional phase II trial of RM-131, the company's novel ghrelin agonist, for the treatment of chronic constipation. Ghrelin is a peptide hormone produced in the stomach that stimulates gastrointestinal motility.
"This is the first of two studies we plan to initiate this year to assess the efficacy and safety of RM-131 for the treatment of lower GI functional disorders," said Elizabeth Stoner, MD, chief development officer, Rhythm. "This initial study will serve as the foundation for developing RM-131 with a priority for treating refractory constipation and potentially irritable bowel syndrome."
The phase II trial is designed to evaluate the effects of RM-131 on symptoms and lower gastrointestinal (GI) function in patients with significant chronic constipation. The trial will assess both the efficacy and safety of RM-131 administered daily for two weeks and is expected to enroll approximately 48 patients. Michael Camilleri, M.D., a gastroenterologist at Mayo Clinic, is the principal investigator for the study.
Rhythm has completed three phase I trials with RM-131 in both healthy volunteers and patients with type 1 and type 2 diabetes, and a phase II trial of RM-131 is currently under way for the treatment of diabetic gastroparesis. The phase I trials demonstrated potent effects of RM-131 on both upper and lower GI function, increasing both gastric emptying and lower GI transit with good tolerability. In one study conducted in healthy volunteers, multiple daily subcutaneous doses of RM-131 reduced colonic transit time by up to 54% from approximately 42 hours in placebo subjects to approximately 18.
"RM-131 has potent prokinetic activity that could improve GI function in patients who are not adequately treated with available therapies,” said Keith Gottesdiener, MD, CEO of Rhythm. “In addition, there is a high incidence of patients with lower GI conditions who also have overlapping upper GI motility disorders, such as Parkinson's disease patients. We are excited about initiating this new phase II study with RM-131 that complements the ongoing phase II study in diabetic gastroparesis."