Allergan has exercised its option to acquire Motus Therapeutics, a gastrointestinal disease subsidiary of Rhythm Holding Company formerly known as Rhythm Health, following positive phase 2b trial results of Motus’ investigational treatment for diabetic gastroparesis, relamorelin, the company announced.
Allergan will pay Rhythm Holding a $200 million exercise price at closing and a contingent payment upon relamorelin’s first commercial sale, and the acquisition is expected to be complete by the end of the year, according to a press release. Allergan has previously paid $47 million related to the option-to-acquire Motus and the phase 2b clinical trial of relamorelin.
Relamorelin (RM-131) is a ghrelin agonist in development for the treatment of gastroparesis in patients with type 1 and type 2 diabetes. The drug candidate, which is derived from the natural ghrelin sequence and stimulates GI motility, has received fast track review status from the FDA.
“The clinical results with relamorelin in this phase 2b trial in diabetic gastroparesis are very encouraging,” David Nicholson, executive vice president of global research and development for Allergan, said in the press release. “Based on these results and the results observed in the earlier phase 2a trial, Allergan has exercised its option to acquire Motus Therapeutics and intends to initiate phase 3 clinical trials of relamorelin.”
The phase 2b randomized, double blind, placebo-controlled trial evaluated the safety and efficacy of 10 µg to 100 µg of relamorelin given twice daily over 12 weeks in 393 patients with diabetic gastroparesis in the U.S. and Europe.
Investigators assessed gastric emptying and key diabetic gastroparesis symptoms in the FDA draft guidance for gastroparesis, including nausea, post-prandial fullness, abdominal pain and bloating. Patients experienced improvements in these endpoints individually and as composite measures, experienced a prokinetic effect on gastric motility, and had about a 75% reduction in vomiting frequency compared with baseline, which served as the primary endpoint.
This was consistent with the phase 2a trial results, although there was an “unusually high” placebo response for the primary endpoint, which limits the efficacy results.
“Patients with diabetic gastroparesis suffer greatly and have very limited treatment options,” Michael Camilleri, MD, a gastroenterologist at Mayo Clinic and advisor on the design and interpretation of the study, said in the press release. “The findings in this trial support initiating phase 3 clinical trials to confirm these phase 2b results with relamorelin for the treatment of moderate to severe diabetic gastroparesis.”
Researchers found the drug was safe and well-tolerated, although there were some dose-related adverse events in some patients related to worsening of glycemic control.
“There has not been a drug approved for gastroparesis by the FDA since 1983,” Richard McCallum, MD, of Texas Tech University, said in the press release. “Relamorelin may offer a much needed opportunity for patients with diabetic gastroparesis to have symptom relief and improved quality of life. It is particularly impressive that relamorelin can be delivered through [subcutaneous] injections because these patients are not able to absorb medications once they start vomiting.”
The companies plan to submit the phase 2b trial data for presentation at a GI conference next year.
Disclosures: Nicholson is employed by Allergan. Healio Gastroenterology was unable to confirm Camilleri’s and McCallum’s relevant financial disclosures.