Allergan PLC issued the following announcement on May 17.
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. 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.
Diabetes is the leading cause of gastroparesis and affects millions of diabetic patients. 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. This delay can worsen a patient's diabetes by making it more difficult to manage blood sugar, which is of paramount importance to patients with diabetes.
"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.
"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. Relamorelin is administered via subcutaneous injection. 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 3bopen-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. Moderate to severe diabetic gastroparesis results in significant debility and hospitalizations and can interfere with nutrition and the absorption of medications. Up to 50 percent of patients with type 1 and type 2 diabetes have been found to have delayed gastric emptying. 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. There is high unmet need in this patient population as available therapies to treat this disorder are limited and may exhibit significant side effects.
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