Rhythm Initiates Phase 2b Clinical Trial of Relamorelin for Diabetic Gastroparesis

BOSTON and DUBLIN, April 8, 2015 /PRNewswire/ -- Rhythm, a biopharmaceutical company, and Actavis plc (NYSE: ACT), a leading global pharmaceutical company, announced today the initiation of a Phase 2b clinical trial assessing the efficacy and safety of relamorelin (RM-131), Rhythm's ghrelin agonist, for the treatment of gastroparesis in patients with type 1 and type 2 diabetes. Ghrelin is a peptide hormone produced in the stomach that stimulates gastrointestinal (GI) motility. Actavis has an exclusive option to acquire Rhythm's wholly owned subsidiary, Rhythm Pharmaceuticals, Inc., upon the completion of the Phase 2b study.

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"This is the second of two studies assessing the efficacy and safety of relamorelin for the treatment of diabetic gastroparesis," said Fred Fiedorek, MD, Chief Medical Officer of Rhythm. "This Phase 2b study is designed to expand our understanding of RM-131's profile for treating diabetic patients with both moderate and severe gastroparesis, prior to the initiation of Phase 3 registration studies."

The Phase 2b trial is designed to evaluate the effect of relamorelin on signs and symptoms of gastroparesis, GI motility, and safety in patients with diabetic gastroparesis. The randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of dosing regimens ranging from 10 to 100 mcg administered twice daily over three months. The trial is expected to enroll approximately 400 patients with diabetic gastroparesis at clinical sites in the U.S. and Europe.

Rhythm previously completed two successful Phase 2 clinical trials with relamorelin:

• In a Phase 2 trial for diabetic gastroparesis, patients treated with relamorelin 10 mcg twice daily demonstrated statistically significant improvements in gastric emptying and vomiting symptoms, and in a pre-specified subgroup also showed statistically significant improvements in the other symptoms of gastroparesis.
• In a separate Phase 2a study for chronic constipation, patients treated with relamorelin 100 mcg once daily for two weeks demonstrated statistically significant improvements in spontaneous bowel movements and in lower GI transit. Relamorelin demonstrated a potent prokinetic effect on GI transit in both studies, as well as in Phase 1 studies, and was generally well tolerated.

"The need for better treatments for diabetic gastroparesis is pressing," said Keith Gottesdiener, MD, CEO of Rhythm. "This is a debilitating condition that affects several million people in the U.S., with only one drug approved by the FDA in the past 30 years. Thus far, relamorelin has been shown to directly improve impaired gastric function in our clinical trials, and we are excited about its potential to significantly improve the health of people suffering from this disorder."

"The clinical results with relamorelin in the initial Phase 2 trial in diabetic gastroparesis were precedent-setting," said David Nicholson, Executive Vice President of Global Brands Research and Development for Actavis. "Both Rhythm and Actavis are looking forward to the results from this important trial, and to the positive impact this drug may have on the lives of people with GI functional disorders."

About Relamorelin (RM-131)
Relamorelin is a Phase 2 ghrelin agonist in development for the treatment of diabetic gastroparesis and GI functional disorders. Derived from the natural ghrelin sequence, relamorelin has been optimized to stimulate gastrointestinal (GI) motility, with greater potency and enhanced stability and pharmacokinetics. Relamorelin has completed a Phase 2 trial in diabetic gastroparesis and a Phase 2a study in chronic constipation, and additional Phase 2 trials are under way in lower GI functional disorders and diabetic gastroparesis. The U.S. Food and Drug Administration (FDA) has granted Fast Track review status to relamorelin for the treatment of diabetic gastroparesis.

About 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 a significant number of the 24 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 Actavis
Actavis plc (NYSE: ACT), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model—Growth Pharma. Actavis is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world. 

Actavis markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Actavis is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

With commercial operations in approximately 100 countries, Actavis 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.

Actavis intends to adopt a new global name – Allergan – pending shareholder approval in 2015.

For more information, visit Actavis' website at www.actavis.com.

About Rhythm (www.rhythmtx.com)
Rhythm is a biopharmaceutical company developing peptide therapeutics that address unmet needs in gastrointestinal diseases and obesity caused by genetic deficiencies in the MC4 pathway. Rhythm is developing the ghrelin peptide agonist, relamorelin (RM-131), for the treatment of diabetic gastroparesis and other gastrointestinal functional disorders; and the MC4R peptide agonist, RM-493, for Prader-Willi syndrome and other MC4 pathway genetic disorders. Rhythm investors include MPM Capital, New Enterprise Associates, Third Rock Ventures, Ipsen, and Pfizer Ventures. The company is based in Boston, Massachusetts.

Actavis Forward-Looking Statement
Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing trends and information as of the date of this release. For instance, any statements in this press release concerning prospects related to Actavis' strategic initiatives, including the option to acquire Rhythm Pharmaceuticals, are forward-looking statements. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' business. These factors include, among others, successful consummation and integration of the potential Rhythm Pharmaceuticals acquisition and the ability to recognize the anticipated benefits of the potential Rhythm Pharmaceuticals acquisition; the anticipated size of the markets and anticipated demand for Rhythm Pharmaceuticals' 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 Actavis' and Rhythm Pharmaceuticals' 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 Actavis' and Rhythm Pharmaceuticals' 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 Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis plc's Annual Report on Form 10-K for the year ended December 31, 2014. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.

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