Phase 2b trial of relamorelin for diabetic gastroparesis intiated

A phase 2b clinical trial of relamorelin for the treatment of gastroparesis in patients with type 1 and type 2 diabetes has been initiated, the manufacturer announced today.

Relamorelin (RM-131; Rhythm) is an agonist of grehlin, a peptide hormone produced in the stomach that stimulates gastrointestinal motility, according to the release.

“This is the second of two studies assessing the efficacy and safety of relamorelin for the treatment of diabetic gastroparesis,” Fred Fiedorek, MD, chief medical officer of Rhythm, said in the release. “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.”

This randomized, double-blind, placebo-controlled trial aims to assess the effects of 10 mcg to 100 mcg relamorelin twice daily for 3 months on signs and symptoms of gastroparesis, gastrointestinal motility and safety in approximately 400 patients with diabetic gastroparesis in the United States and Europe.

“The need for better treatments for diabetic gastroparesis is pressing,” Keith Gottesdiener, MD, CEO of Rhythm, said in the release. “This is a debilitating condition that affects several million people in the U.S., with only one drug approved by the FDA in the past 30 years. Thus far, relamorelin has been shown to directly improve impaired gastric function in our clinical trials, and we are excited about its potential to significantly improve the health of people suffering from this disorder.”

This trial follows two previously successful phase 2 clinical trials of relamorelin, one of which demonstrated improvement in gastric emptying, vomiting and other symptoms in patients with diabetic gastroparesis, and another which showed improvement in spontaneous bowel movements and lower gastrointestinal transit in patients with chronic constipation, the release said. A prokinetic effect on gastrointestinal transit was also demonstrated in both studies, as well as in phase 1 studies, and was well tolerated.

“The clinical results with relamorelin in the initial phase 2 trial in diabetic gastroparesis were precedent-setting,” David Nicholson, executive vice president of global brands research and development for Actavis, said in the release. “Both Rhythm and Actavis are looking forward to the results from this important trial, and to the positive impact this drug may have on the lives of people with GI functional disorders.”

Upon successful completion of this trial, Actavis has an exclusive option to purchase Rhythm subsidiary, Rhythm Pharmaceuticals, the release said.

Disclosure: Fiedorek and Gottesdiener are employees of Rhythm. Nicholson is an employee of Actavis.