DUBLIN and BOSTON, Oct. 27, 2016 /PRNewswire/ -- Allergan plc. (NYSE: AGN), 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.
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 of Allergan's acquisition of Motus Therapeutics is expected to occur by the end of 2016 subject to customary closing conditions.
About Relamorelin (RM-131)
Relamorelin is a potent ghrelin agonist in development for the treatment of diabetic gastroparesis. Derived from the natural ghrelin sequence, relamorelin has been optimized to stimulate gastrointestinal (GI) motility, with greater potency and enhanced stability and pharmacokinetics. The U.S. Food and Drug Administration (FDA) has granted Fast Track review status to relamorelin for the treatment of diabetic gastroparesis.
About Diabetic Gastroparesis
Diabetic gastroparesis is a disorder in which there is a substantial delay in stomach emptying with characteristic symptoms of vomiting, nausea, abdominal pain, early satiety, and bloating. Moderate to severe diabetic gastroparesis results in significant debility and hospitalizations and can interfere with nutrition and the absorption of medications. Gastroparesis affects between 11 and 21 percent of the 29 million diabetics in the U.S; an estimated 2.3 million type 1 and type 2 diabetic patients with moderate or severe gastroparesis symptoms are seeking treatment. Available therapies to treat this disorder are limited and exhibit significant side effects. No new therapies have been approved in the U.S. for the treatment of gastroparesis in more than 30 years.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. Allergan is an industry leader in Open Science, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 65+ mid-to-late stage pipeline programs in development. Our Company's success is powered by our more than 16,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives. For more information, visit Allergan's website at www.Allergan.com.
About Motus and Rhythm Holding
Motus ( www.motustx.com ) is a biopharmaceutical company focused on developing peptide therapeutics for the treatment of gastrointestinal (GI) diseases. Motus, formerly Rhythm Health, Inc., is a subsidiary of Rhythm Holding Company, LLC. Motus is developing the ghrelin peptide agonist, relamorelin (RM-131. Rhythm Pharmaceuticals, Inc. (www.rhythmtx.com) is another subsidiary of Rhythm Holding Company, LLC, focusing on developing peptide therapeutics for the treatment of rare genetic deficiencies that result in life-threatening metabolic disorders. Rhythm's lead peptide product candidate is setmelanotide, a first-in-class melanocortin 4 receptor (MC4R) agonist for the treatment of rare genetic disorders of obesity. The companies are based in Boston, Massachusetts.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, successful consummation and integration of the acquisition of Motus Therapeutics and the ability to recognize the anticipated benefits of the acquisition of Motus Therapeutics; the anticipated size of the markets and anticipated demand for Motus Therapeutics' products; the impact of competitive products and pricing; the inherent uncertainty associated with financial projections; periodic dependence on a small number of products for a significant source of net revenue or income; variability of trade-buying patterns; changes in generally accepted accounting principles; the risks and uncertainties normally incident to the pharmaceutical industry; risks that the carrying values of assets may be negatively impacted by future events and circumstances; the timing and success of product launches; the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals or actions, if any; market acceptance of and continued demand for Allergan's and Motus Therapeutics' products; costs and efforts to defend or enforce intellectual property rights; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with governmental regulations applicable to Allergan's and Motus Therapeutics' facilities, products and/or businesses; changes in the laws and regulations affecting, among other things, pricing and reimbursement of pharmaceutical products; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016 (certain of such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.