Allergan to close down buying Motus, relamorelin goes to Phase 3 tests

Allergan on Thursday announced the results of Phase 2b study of the new gastroparesis drug relamorelin, first they hope to be approved by the FDA since 1983.
The test is taken still under Rhythm Holding’s subsidiary Motus Therapeutics, the company focused on gastrointestinial disosrders treatments, and which Allergan is set forth to buy.

The Irish drugmaker has shown that in Phase 2b trial of efficiancy and safety of Motus’ ghrelin agonist for treating gastroparesis in diabetes 1 and 2 patients, there is still room for improvement, due to strange vomiting level on placebo.

The Phase 2b study has so far shown that 12 weeks of relamorelin was effective for the patients with main gastroparesis symptoms, which include abdominal pain. It also reduced vomiting, which was similar to Phase 2a trial.

However, an unusually high placebo response for vomiting frequency, extending well beyond that expected from previous studies, limited the ability to demonstrate treatment efficacy on the vomiting frequency endpoint.

David Nicholson, Executive Vice President of Global Research and Development for Allergan, said: “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.”

Richard McCallum, MD, of Texas Tech University, said: “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. 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.”

Bart Henderson, President and Founder of Rhythm Holding commented: “We are very excited that Allergan has exercised its option to acquire Motus and that relamorelin will now advance into Phase 3 trials.

“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.”

Keith Gottesdiener, MD, CEO of Rhythm Holding, has emphasised the urgency for better treatments for diabetic gastroparesis.

“This is a devastating condition that affects several million people in the U.S., 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,” said Gottesdiener.

About the Acquisition
As a result of exercising its option to acquire Motus Therapeutics, Allergan will pay the exercise price of $200 million at closing to Rhythm Holding. In addition, Rhythm Holding will be eligible for a contingent payment upon first commercial sale of relamorelin. Allergan previously made $47 million in payments related to the option-to-acquire Motus and the relamorelin Phase 2b clinical trial. Completion ofAllergan’s acquisition of Motus Therapeutics is expected to occur by the end of 2016 subject to customary closing conditions.