Rhythm, a biopharmaceutical company, and Actavis plc, a leading global pharmaceutical company, announced the initiation of a phase 2b clinical trial assessing the efficacy and safety of relamorelin (RM-131), Rhythm's ghrelin agonist, for the treatment of gastroparesis in patients with type 1 and type 2 diabetes. Ghrelin is a peptide hormone produced in the stomach that stimulates gastrointestinal (GI) motility. Actavis has an exclusive option to acquire Rhythm's wholly owned subsidiary, Rhythm Pharmaceuticals, Inc., upon the completion of the phase 2b study.
"This is the second of two studies assessing the efficacy and safety of relamorelin for the treatment of diabetic gastroparesis," said Fred Fiedorek, MD, chief medical officer of Rhythm. "This phase 2b study is designed to expand our understanding of RM-131's profile for treating diabetic patients with both moderate and severe gastroparesis, prior to the initiation of phase 3 registration studies."
The phase 2b trial is designed to evaluate the effect of relamorelin on signs and symptoms of gastroparesis, GI motility, and safety in patients with diabetic gastroparesis. The randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of dosing regimens ranging from 10 to 100 mcg administered twice daily over three months. The trial is expected to enroll approximately 400 patients with diabetic gastroparesis at clinical sites in the US and Europe.
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