Motus Therapeutics (formerly Rhythm Health) has completed enrolment for a phase 2b clinical trial that will assess the efficacy and safety of relamorelin (RM-131), its ghrelin agonist, for treatment of gastroparesis in patients with type 1 and type 2 diabetes.
Ghrelin is known to be a peptide hormone produced in the stomach that stimulates gastrointestinal (GI) motility.
Following completion of the phase 2b study, global branded and generic pharmaceuticals company Allergan has an exclusive option to acquire Motus Therapeutics.
During the phase 2b trial, the effect of relamorelin on signs and symptoms of gastroparesis, GI motility, and safety in patients with diabetic gastroparesis will be evaluated.
The randomised, double-blind, placebo-controlled study is also assessing the safety and efficacy of dosing regimens ranging from 10mcg to 100mcg administered twice-daily over three months.
A total of 396 patients with diabetic gastroparesis have been enrolled for the trial at clinical sites in the US and Europe.
Motus previously undertook 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 demonstrated improvements in the other symptoms of gastroparesis.
Diabetic gastroparesis is a kind of disorder where there is a significant delay in the stomach emptying, with symptoms being vomiting, nausea, abdominal pain, early satiety, and bloating.
Moderate to severe diabetic gastroparesis can cause significant weakness and hospitalisations, as well as interfering with nutrition and the absorption of medications.
Gastroparesis currently has limited therapies, affecting 24 million diabetics in the US, with an estimated 2.3 million type 1 and type 2 diabetic patients with moderate or severe gastroparesis symptoms seeking treatment.
No new therapies have been approved in the US for treating gastroparesis in more than 30 years.
Relamorelin is a ghrelin agonist in development to treat diabetic gastroparesis and gastrointestinal (GI) functional disorders. It has completed a phase 2a clinical trial in diabetic gastroparesis and a phase 2a trial in chronic constipation.
The US Food and Drug Administration (FDA) has awarded fast-track review status to relamorelin for treating diabetic gastroparesis.