DUBLIN, May 17, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced the expansion of the PLEDGE program with a fifth study now evaluating relamorelin, an investigational, ghrelin agonist being studied for the treatment of diabetic gastroparesis (DG). Recruitment remains underway for the pivotal Phase 3 studies RLM-MD-01 and RLM-MD-02. Patients who complete 52 weeks of the Phase 3 program will now be eligible for the RLM 3071-305-020 open-label study to evaluate the long-term safety of the investigational drug.
This new study (RLM 3071-305-020) will follow participants for up to five years to provide additional information on the long-term safety profile of relamorelin.1 It also enables eligible patients to potentially have access to relamorelin until it is commercially available. The clinical goal of this study is to collect additional information on the long-term safety of relamorelin in this highly challenging patient population.1
Diabetes is the leading cause of gastroparesis and affects millions of diabetic patients.2 It is a disorder in which there is a substantial delay in stomach emptying and is characterized by nausea, vomiting, bloating, and other gastrointestinal complications.3 This delay can worsen a patient's diabetes by making it more difficult to manage blood sugar,3 which is of paramount importance to patients with diabetes.4
"The goal of managing diabetes is to keep blood sugar levels within a safe range. This is problematic in people with diabetic gastroparesis, or DG, because they cannot predict when the food or medicine will be absorbed and what impact this delay will have on their blood sugar levels," said Dr. Brian E. Lacy, MD, PhD, Gastroenterologist at Mayo Clinic Jacksonville. "New research, as done through the current PLEDGE program, is greatly needed as there are currently limited therapeutic options for patients living with DG."
PLEDGE is a multi-study, patient-centric program designed to evaluate the safety and efficacy of relamorelin in people with DG. Allergan initiated the PLEDGE program following the results of a Phase 2b study that showed improvements in many of the core symptoms of DG compared to placebo.5
"The PLEDGE program is one of Allergan's many commitments to patients that could change treatment paradigms across gastroenterology," said David Nicholson, Chief R&D Officer, Allergan. "We're eager to continue enrolling additional patients and remain dedicated to helping the millions of people suffering from the debilitating effects of DG."
For more information on the PLEDGE program, or to participate, visit www.AllerganDG.com.
More About Relamorelin
Relamorelin is a potent ghrelin agonist in development for the treatment of diabetic gastroparesis.6 Relamorelin is administered via subcutaneous injection.7 The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to relamorelin for the treatment of diabetic gastroparesis.
More About the PLEDGE Clinical Research Program
PLEDGE consists of five studies with up to a five-year commitment.:
- RLM-MD-01 and RLM-MD-02 are two identical, pivotal, 12-week, randomized, double-blind, placebo-controlled studies evaluating the safety and efficacy of relamorelin compared to placebo;7,8 Currently enrolling;
- RLM-MD-03 is a long-term extension roll-over (from -01 and -02) placebo-controlled trial that evaluates the safety and efficacy of relamorelin treatment for up to one year;9
- RLM-MD-04 is a non-pivotal 12-month study in less severe DG patients evaluating the safety and efficacy of relamorelin treatment;10
- RLM 3071-305-020 is a Phase 3b open-label extension trial which will enroll patients who complete either -03 or -04.5
More About Diabetic Gastroparesis
Diabetic gastroparesis is a disorder in patients with diabetes in which there is a substantial delay in stomach emptying with characteristic signs and symptoms of vomiting, nausea, abdominal pain, early satiety, postprandial fullness, and bloating.3 Moderate to severe diabetic gastroparesis results in significant debility and hospitalizations and can interfere with nutrition and the absorption of medications.11 Up to 50 percent of patients with type 1 and type 2 diabetes have been found to have delayed gastric emptying.12 However, diagnosed prevalence of symptomatic diabetic gastroparesis has been estimated to be as low as five percent of patients with type 1 diabetes and one percent of patients with type 2 diabetes, possibly reflecting under-recognition in clinical practice.2 There is high unmet need in this patient population as available therapies to treat this disorder are limited and may exhibit significant side effects.13
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.
With colleagues and commercial operations located 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 every day.
For more information, visit Allergan's website at www.Allergan.com.
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 on existing trends and information as of the date of this release. 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, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; 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, 2018 and Allergan's Quarterly Report on Form 10-Q for the period ended March 31, 2019. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
Manisha Narasimhan, PhD
Allergan. (2018). Diabetic Gastroparesis Study 05. (ClinicalTrials.gov Identifier: NCT03786380). Retrieved from https://clinicaltrials.gov/ct2/show/NCT03786380
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Allergan. (2018). A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis. (ClinicalTrials.gov Identifier: NCT03285308). Retrieved from https://clinicaltrials.gov/ct2/show/NCT03285308
Allergan. (2018). Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis Study 02. (ClinicalTrials.gov Identifier: NCT03426345). Retrieved from https://clinicaltrials.gov/ct2/show/NCT03426345
Allergan. (2018). A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03. (ClinicalTrials.gov Identifier: NCT03420781). Retrieved from https://clinicaltrials.gov/ct2/show/NCT03420781
Allergan. (2017). A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04. (ClinicalTrials.gov Identifier: NCT03383146). Retrieved from https://clinicaltrials.gov/ct2/show/NCT03383146
Krishnasamy, S., & Abell, T. L. (2018). Diabetic Gastroparesis: Principles and Current Trends in Management. Diabetes therapy : research, treatment and education of diabetes and related disorders, 9(Suppl 1), 1-42.
Gastroparesis. (2012). Retrieved from https://rarediseases.org/rare-diseases/gastroparesis/
Parkman HP, Fass R, Foxx-Orenstein AE. Treatment of patients with diabetic gastroparesis. Gastroenterol Hepatol (N Y). 2010;6(6):1-16.
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