MacroGenics Begins Phase 2/3 Study In Type 1 Diabetes Mellitus

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MacroGenics's Protege trial is actively enrolling adults and children ages 8 to 35 with recent-onset type 1 diabetes.

The global Phase 2/3 clinical trial will evaluate the safety and efficacy of three teplizumab dosing regimens administered at the start of the study and again at six months in individuals who are up to 12 weeks from their diagnosis of type 1 diabetes.

"The initiation of the pivotal Protege study is an important milestone for MacroGenics and for the type 1 diabetes research community," stated Dr. Scott Koenig, President and CEO of MacroGenics. "It is also notable that teplizumab is the first CD3 monoclonal therapy targeting type 1 diabetes to reach this stage of clinical development."

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Specifically, the Protege study will assess the ability of teplizumab to inhibit the autoimmune attack that destroys insulin-producing pancreatic beta cells in individuals with type 1 diabetes. If teplizumab is effective and has the ability to preserve or protect beta cells of the pancreas, patients may require less injected insulin and their blood glucose levels may be easier to control. Other research has shown that greater control of blood glucose levels can lead to better long-term health outcomes for patients with type 1 diabetes.

Dr. Koenig also commented, "We are pleased to announce that Dr. Kevan Herold of Yale University and Dr. Bernhard Hering of the University of Minnesota are leading additional teplizumab studies in type 1 diabetes." The AbATE and Delay studies, led by Dr. Herold, are evaluating the safety and efficacy of teplizumab in patients who have had the disease for up to one year. Dr. Hering is evaluating the use of teplizumab as an induction therapy in pancreatic islet cell transplantation.

Teplizumab, also called MGA031 and hOKT3-gamma-1 (Ala-Ala), is a humanized monoclonal antibody engineered to alter the function of the T lymphocytes that mediate the destruction of the insulin-producing beta cells of the islets of the pancreas. Teplizumab binds to an epitope of the CD3-epsilon chain expressed on mature T cells and by doing so, may modulate the immunologic response that causes disease.

Type 1 diabetes is an autoimmune disease in which the body's immune system attacks and destroys the insulin-producing beta cells of the pancreas. The symptoms associated with type 1 diabetes can appear suddenly and leave a person dependent on injected insulin for life. The disease carries the constant threat of devastating complications such as heart and kidney disease, nerve damage and blindness. Although diagnosis most often occurs in childhood and adolescence, the disease can strike adults as well. Individuals with type 1 diabetes must test their blood sugar four or more times per day and take multiple insulin injections daily or continually infuse insulin through a pump. While trying to balance insulin doses with their food intake and daily activities, people with this form of diabetes must always be prepared for serious hypoglycemic (low blood sugar) and hyperglycemic (high blood sugar) reactions, both of which impact quality of life and can be life threatening. This balance is especially difficult to achieve in children and young adults who are very active physically.

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