BOSTON, April 4, 2016 /PRNewswire/ -- Motus announced today the completion of enrollment for a Phase 2b clinical trial assessing the efficacy and safety of relamorelin (RM-131), Motus' 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. Allergan has an exclusive option to acquire Motus Therapeutics, Inc. upon the completion of this Phase 2b study.
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 is evaluating the safety and efficacy of dosing regimens ranging from 10 to 100 mcg administered twice daily over three months. The trial enrolled 396 patients with diabetic gastroparesis at clinical sites in the U.S and Europe.
Prior to this study, Motus completed a Phase 2a trial of relamorelin in 204 patients with diabetic gastroparesis that demonstrated statistically significant improvements in gastric emptying and vomiting symptoms, and in a pre-specified subgroup also showed statistically significant improvements in the other symptoms of gastroparesis.
About Diabetic Gastroparesis
Diabetic gastroparesis is a disorder in which there is a substantial delay in stomach emptying with characteristic symptoms of vomiting, nausea, abdominal pain, early satiety, and bloating. Moderate to severe diabetic gastroparesis results in significant debility and hospitalizations and can interfere with nutrition and the absorption of medications. Gastroparesis affects a significant number of the 24 million diabetics in the U.S; an estimated 2.3 million type 1 and type 2 diabetic patients with moderate or severe gastroparesis symptoms are seeking treatment. Available therapies to treat this disorder are limited and exhibit significant side effects. No new therapies have been approved in the U.S. for the treatment of gastroparesis in more than 30 years.
About Relamorelin (RM-131)
Relamorelin is a 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 GI motility, with greater potency and enhanced stability and pharmacokinetics. Relamorelin has completed a Phase 2a clinical trial in diabetic gastroparesis and a Phase 2a study in chronic constipation. The U.S. Food and Drug Administration (FDA) has granted Fast Track review status to relamorelin for the treatment of diabetic gastroparesis.
Motus is a biopharmaceutical company focused on developing peptide therapeutics for the treatment of gastrointestinal (GI) diseases. Motus, formerly Rhythm Health, Inc., is a subsidiary of Rhythm Holding Company, LLC and is based in Boston, Massachusetts.
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