RK-01: A Think-Outside-The-Box Approach To Sustained Glycemic Control
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 and decrease insulin resistance. Results from the translational animal studies suggest that it can prevent failure of Metformin treatment.
Results obtained from the animal studies as well as controlled clinical studies support the scientific rationale and the product concept.
Type 2 diabetes patients with high blood pressure (>85%) as well as arthritis as a coexisting condition (>47% of the adults with diabetes) are underserved by the currently marketed drugs.
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.