Allergan plc., a leading global pharmaceutical company and Rhythm Holding Company, LLC, which owns Motus Therapeutics, Inc. a biopharmaceutical company developing peptide therapeutics for the treatment of gastrointestinal (GI) disorders, announced today the top line results of a Phase 2b clinical trial assessing the efficacy and safety of relamorelin (RM-131), Motus' ghrelin agonist, for the treatment of gastroparesis in patients with type 1 and type 2 diabetes. Allergan also announced that it has exercised its option to acquire Motus Therapeutics. Motus (formerly known as Rhythm Health) is a wholly-owned subsidiary of Rhythm Holding Company, LLC.
In the Phase 2b study, relamorelin administered for 12 weeks demonstrated substantial efficacy for the key diabetic gastroparesis symptoms of nausea, post-prandial fullness, abdominal pain and bloating (measured both individually and as a composite endpoint), along with a potent prokinetic effect on gastric motility. Patients receiving relamorelin also experienced an approximately 75 percent reduction in vomiting frequency across all doses compared to baseline (the primary endpoint), similar to the effect seen in the 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.
"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 Phase 2b trial was designed to evaluate the effect of relamorelin on the key signs and symptoms of gastroparesis identified in the draft FDA guidance for gastroparesis, as well as gastric emptying and safety in patients with moderate to severe diabetic gastroparesis and with symptoms of vomiting at baseline. The randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of dosing regimens ranging from 10 to 100 mcg administered twice daily over three months. The trial enrolled 393 patients with diabetic gastroparesis at clinical sites in the U.S. and Europe.
"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."
"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."
Overall, relamorelin was safe and well-tolerated in the phase 2b study with high compliance and completion rates over the course of the study. There was some evidence of dose-related adverse events related to worsening of glycemic control in some patients.
Motus Therapeutics previously completed a successful 4-week Phase 2 clinical trial of relamorelin in diabetic gastroparesis, in which patients treated with relamorelin 10 mcg twice daily demonstrated statistically significant improvements in gastric emptying and vomiting frequency and in a pre-specified subgroup also showed statistically significant improvements in the other symptoms of gastroparesis.
"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."
"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 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."
Rhythm Holding and Allergan plan to submit the data for presentation at a major gastrointestinal medical conference in 2017.
Source : allergan.com