Anji Pharmaceuticals, Inc. today announced the acquisition of global development rights for a novel delayed-release formulation of metformin. Originally developed by Elcelyx Therapeutics, Metformin DR is an investigational product designed to target metformin delivery to the lower small intestine. In a recent Phase 2b study with 571 enrolled subjects, Metformin DR afforded robust glucose lowering with significantly reduced systemic exposure, demonstrating a tolerability profile potentially suitable for type 2 diabetes patients who are currently restricted or contraindicated to metformin use (due to impaired renal function) or those with poor tolerance to other metformin regimens. Having received input from the FDA on its clinical development plan, Anji plans to initiate a pivotal Phase 3 study in patients with Chronic Kidney Disease (Stage 3b/4) later this year.
“We are extremely excited to add Metformin DR to our late-stage clinical pipeline,” noted Dr. Dan Meyers, Chief Medical Officer of Anji. “We recognize the importance of new treatment options for patients with type 2 diabetes with advanced kidney disease who cannot take metformin due to risk of lactic acidosis. Metformin DR has the potential to give CKD patients access to a first-line therapy that has been the mainstay for decades.”
“We are very pleased to see the continued progression of Metformin DR through our partnership with Anji,” comments Alain Baron, MD, president and Chief Executive Officer of Elcelyx. “Finding a science-driven organization that recognized the tremendous potential of gut-specific delivery of metformin was crucial to our program strategy. We are excited to work with Anji on the Ph3 global program of Metformin DR and accelerate its availability to patients in need of better glycemic control.”
Date: June 03, 2019
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Source: Yahoo Finance
