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RK-01: A Think-Outside-The-Box Approach To Sustained Glycemic Control
The scientific rationale for RK-01 is based on the pancreatic ‘beta-cell-centric’ concept developed by Stan Schwartz, MD a renowned endocrinologist and an Emeritus Associate Clinical Professor, University of Pennsylvania. Dr. Schwartz proposed reclassifying diabetes and treat patients by stratifying them based on the defects and the mechanisms that contribute to beta cell dysfunction, the core defect (Schwartz, S.S. et al. Diabetes Care 2016; 39: 179-186). RK-01 targets the self-reinforcing cascade of multidimensional and unifying inflammatory pathways that originate from several clinically relevant cell types and it is expected to maintain or restore a state of insulin sufficiency. Dr. Schwartz is the Chief Medical Advisor for ARKAY Therapeutics.
Type 2 diabetes is characterized by pancreatic beta cell failure and insulin resistance. It continues to be an unmet medical need because currently marketed "me-too" drugs are inadequate in filling one of the most important gaps in the space: sustained glycemic control, with a focus on preserving beta cell function and decreasing insulin resistance.
~50% of over 1 million newly diagnosed patients experienced primary failure with Metformin (the current first-line of therapy) and secondary failure with second and third add-on antidiabetes drugs from 2005 to 2016 in real-world clinical practice in the United States (Montvida, O. et al. Diabetes Care 2018).
RK-01 is an innovative, patient-centric drug. It is custom-designed and formulated to prevent beta cell failure, decrease insulin resistance and prevent failure of Metformin treatment. The scientific rationale and the product concept are supported by the results obtained from the animal as well as controlled clinical studies. Endorsed by the leading experts in the diabetes space.
>85% Type 2 diabetes patients have high blood pressure and >47% of the adults with diabetes also have arthritis as a coexisting condition.
The U.S. FDA has approved ARKAY's IND application for evaluating RK-01 in adult obese type 2 diabetes patients with high blood pressure and arthritis (ClinicalTrials.gov Identifier: NCT03686657).
Currently raising capital for the human clinical study.