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TriGlytza™: A Patient-Centric Think-Outside-The-Box Approach For Treating Type 2 Diabetes and COVID-19
The scientific rationale and the product concept for RK-01 or TriGlytza™ for treating Type 2 diabetes are based on the pancreatic ‘beta-cell-centric’ concept developed by the founder, Ravi Kumar, Ph.D. and Chief Medical Advisor, Stan Schwartz, MD, a renowned endocrinologist and an Emeritus Associate Clinical Professor of Medicine, University of Pennsylvania. Dr. Schwartz proposed treating patients by stratifying them based on the defects and the mechanisms that contribute to hyperglycemia and beta cell dysfunction, the core defect (Schwartz, S.S. et al. Diabetes Care 2016; 39: 179-186). TriGlytza™ targets the self-reinforcing cascade of multidimensional and unifying inflammatory pathways that originate from several clinically relevant cell types. As supported by the PoC clinical studies with small patient populations, it is expected to restore beta cell function and/or prevent beta cell failure, and maintain a state of insulin sufficiency.
Type 2 diabetes is a complex metabolic disorder characterized by pancreatic beta cell failure in the setting of insulin resistance. 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.
Type 2 diabetes continues to be an unmet medical need because almost 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).
TriGlytza™ is an innovative, patient-centric drug. Unlike the currently marketed drugs which treat Type 2 diabetes in isolation, it treats the disease in the context of comorbidities and coexisting conditions by targeting the multidimensional pathophysiology. 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 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 as a comorbidity 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 or TriGlytza™ in adult obese type 2 diabetes patients with high blood pressure and arthritis (ClinicalTrials.gov Identifier: NCT03686657).
COVID-19 is an acute inflammatory disease. ARDS (Acute Respiratory Distress Syndrome) is the hallmark of the disease. The shift in the balance between ACE2 and ACE/Angiotensin II/PGE2 is fundamental to the clinical pathophysiology of ARDS. There's a direct correlation between the levels of PGE2 and the severity of ARDS as shown by recent publications. Therefore, the drug combination product, TriGlytza™ custom-designed to counter-regulate RAS-Ang II-PGE2 axis makes perfect sense for not only treating but more importantly for mitigating the severity of ARDS as well as MODS (Multi Organ Dysfunction Syndrome). The component drugs in TriGlytza™ have clinical proof-of-concept (PoC) for treating ARDS.
Currently raising capital for the human clinical trials.