ANJ900 offers improved glycemic control with reduced systemic exposure to metformin.
ANJ900 controls blood sugar through a novel gut-targeted mechanism.
ANJ900 leverages recent insight that the primary site-of-action of metformin, a mainstay of oral Type 2 diabetes therapy, is the region of cells lining the gut wall.
With this discovery, the dissolution of ANJ900 has been optimized to deliver metformin only where it’s needed. Gut-targeted therapy avoids unnecessary metformin absorption – a major safety risk for millions of Type 2 diabetes patients with chronic kidney disease.
Two Phase 3 clinical trials are planned to support the New Drug Application (NDA) for ANJ900. The first trial (“DREAM-T2D”) is designed to show HbA1c lowering in T2D patients with moderate CKD (1-3B), and will utilize a 505(b)(2) pathway for FDA approval. The second trial (“DREAM-CKD”) will expand access of ANJ900 to patients with advanced CKD (3B and 4), getting this critical therapy to patients who need it most.
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