Actavis, Rhythm Advance GI DrugBy
Actavis and Rhythm, a biopharmaceutical company, have initiated a Phase IIb 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. Actavis has an exclusive option to acquire Rhythm’s wholly owned subsidiary, Rhythm Pharmaceuticals, Inc., upon the completion of the Phase IIb study.
Ghrelin is a peptide hormone produced in the stomach that stimulates gastrointestinal (GI) motility. Relamorelin is a Phase II ghrelin agonist in development for the treatment of diabetic gastroparesis and gastrointestinal (GI) functional disorders. Derived from the natural ghrelin sequence, relamorelin has been optimized to stimulate gastrointestinal (GI) motility, with greater potency and enhanced stability and pharmacokinetics. Relamorelin has completed a Phase II trial in diabetic gastroparesis and a Phase IIa study in chronic constipation, and additional Phase II trials are under way in lower GI functional disorders and diabetic gastroparesis. The US Food and Drug Administration (FDA) has granted Fast Track review status to relamorelin for the treatment of diabetic gastroparesis.