Allergan to Acquire Gastrointestinal Disease Company

Allergan recently announced plans to acquire Motus Therapeutics, the gastrointestinal disease division of Rhythm Holding Company.

Motus has announced top-line results of a phase 2b clinical trial studying the safety and efficacy of relamorelin (RM-131) in patients with diabetes who have gastroparesis, and Allergan announced its option to acquire the company, according to a press release.

Diabetic gastroparesis is a condition where there is delay in the stomach empyting, with symptoms such as vomiting, nausea, abdominal pain, early satiety, and bloating. Moderate-to-severe disease can cause frailty and hospitalization that can interfere with nutrition and medications. This disease affects 11% to 21% of patients with diabetes in the US.

“The clinical results with relamorelin in this Phase 2b trial in diabetic gastroparesis are very encouraging. 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,” said David Nicholson, executive vice president of Global Research and Development for Allergan. “We very much look forward to sharing this phase 2b data with the US Food and Drug Administration and to discussing our plans to conduct Phase 3 trials.”

The study was designed to determine the effect of the drug on signs and symptoms of diabetic gastroparesis and gastric emptying and safety in these patients. There were 393 patients with moderate-to-severe diabetic gastroparesis who had symptoms of vomiting included in the study.

Patients were randomized to receive 10 to 100 mcg of relamorelin or placebo for 12 weeks. Researchers found that it decreased symptoms of diabetic gastroparesis, including nausea, post-prandial fullness, abdominal pain and bloating. A strong prokinetic effect was also seen on gastric motility.

Patients treated with relamorelin also had a 75% reduction in vomiting, which was the primary endpoint of the trial. However, there was an unusually high placebo response for this endpoint, which limits the ability to determine relamorelin’s ability to reduce vomiting, according to Allergan.

Overall, the drug was safe and well-tolerated. Dose-related adverse events included worsening of glycemic control in certain patients.

“Patients with diabetic gastroparesis suffer greatly and have very limited treatment options,” said Michael Camilleri, MD, gastroenterologist at Mayo Clinic who was an advisor on the design and interpretation of the study. “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.”

Relamorelin is an investigational ghrelin antagonist that can stimulate gastrointestinal (GI) motility, and has greater potency, stability, and pharmacokinetics, according to the press release.

The FDA has previously granted the drug Fast Track review status for this indication.

“There has not been a drug approved for gastroparesis by the FDA since 1983. Relamorelin may offer a much needed opportunity for patients with diabetic gastroparesis to have symptom relief and improved quality of life,” said Richard McCallum, MD, of Texas Tech University. “It is particularly impressive that relamorelin can be delivered through SC injections because these patients are not able to absorb medications once they start vomiting. Relamorelin may be a major advance in the armamentarium of physicians who manage diabetic gastroparesis.”

Motus previously completed a phase 2 trial of relamorelin where patients were treated with 10 mcg twice per day. Researchers found that patients treated with relamorelin has significant improvements in gastric emptying and vomiting. A subgroup also had improvements in other symptoms of the disease, Allergan reported.

Under the agreement, Allergan will pay $200 million to Rhythm Holding. They have previously paid $47 million relating to the option-to-acquire Motus and the phase 2 clinical trial. The acquisition is expected to close by the end of the year.

“We are very excited that Allergan has exercised its option to acquire Motus and that relamorelin will now advance into Phase 3 trials,” said Bart Henderson, president and founder of Rhythm Holding. “Relamorelin has enormous potential to improve the lives of patients with GI functional disorders, and Allergan has the skill and resources to develop and commercialize this promising drug to its fullest potential.”

This acquisition will not only expand Allergan’s gastrointestinal drug profile, but will also provide novel treatments for patients with diabetic gastoparesis (DG). Current treatments are limited, and can cause significant side effects.

“The need for better treatments for diabetic gastroparesis is urgent,” said Keith Gottesdiener, MD, CEO of Rhythm Holding. “This is a devastating condition that affects several million people in the US, with only one drug approved by the FDA in the past 30 years. In this clinical trial, relamorelin improves gastric function, and shows substantial efficacy for the debilitating symptoms of DG. We thank everyone who has participated in this clinical trial. And we thank Allergan for joining with us to help advance this potentially breakthrough treatment for patients who may benefit from it.”