Updated data on PLEDGE program of relamorelin to treat diabetic gastroparesis

Allergan plc 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 III studies RLM-MD-01 and RLM-MD-02. Patients who complete 52 weeks of the Phase III 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 IIb study that showed improvements in many of the core symptoms of DG compared to placebo.