ARKAY Therapeutics

ARKAY is a privately-held clinical stage pharmaceutical company located in East Windsor, NJ. ARKAY is developing an innovative, proprietary, orally active 'first-in-class' pancreatic 'Beta-cell-centric'​ dual combination product, TriGlytza for providing sustained glycemic control for patients with Type 2 diabetes. Unlike the currently marketed treatment options, TriGlytza is custom-designed and formulated to prevent or delay pancreatic beta cell failure, maintain a state of insulin sufficiency and decrease insulin resistance. It fills the most important clinical gap that exists in the modalities by blocking multiple distinct yet overlapping cell signaling pathways along the immune dysregulation-inflammation-insulin resistance axis. Results from the preclinical study performed with C57BL/6J DIO mice with insulin resistance and pancreatic beta cell dysfunction were presented at the 76th Scientific Sessions of the American Diabetes Association, June 10-14, 2016, New Orleans, LA. Almost 50% of Type 2 diabetes patients experience primary failure with Metformin, the current first line of therapy in the United States. Component drugs in TriGlytza have restored blood glucose levels in patients with inadequate blood glycemic control with Metformin. ARKAY's scientific rationale and the product concept has endorsed by leading endocrinologists. We are on track to bring TriGlytza to the market by 2026. The U.S. FDA approved ARKAY's IND application in May 2018. COVID-19 is an acute inflammatory disease. TriGlytza can counter-regulate mechanisms along the RAS and Cox2-PGE2 axis. Results from the clinical PoC study suggest that TriGlytza can be used for for treating or mitigating ARDS. It can also be used as an adjunctive therapy. ARKAY is currently raising capital for developing the formulation and the clinical trials. Our business plan is to partner or merge with a pharmaceutical company in the Type 2 diabetes space after a successful Phase 2 clinical trial.