The U.S. FDA Approves ARKAY Therapeutics’ IND Application for Evaluating RK-01, a First-in Class ‘Beta-cell-centric’ Drug Combination Product in Type 2 Diabetes Patients
Human Proof-of-Concept (PoC) Trial to Evaluate the Superiority of RK-01 Over Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control.
ARKAY Therapeutics, LLC, a privately held biopharmaceutical company focused on developing innovative, orally-active combination products for the treatment of type 2 diabetes and related disorders, announced today that the U.S. FDA has approved its IND application and the clinical study “may proceed.” ARKAY Therapeutics plans to evaluate the safety, tolerability, and superiority of RK-01 over metformin in newly diagnosed drug-naïve as well as obese type 2 diabetes patients with inadequate glycemic control with metformin monotherapy. RK-01 is a proprietary formulation of valsartan plus celecoxib dual add-on to metformin-HCl XR. Metformin is the current first-line of therapy. “The approval of the IND application is an important milestone for the company. We expect RK-01 to prevent metformin failure by maintaining a state of insulin sufficiency and reduce the risk of insulin dependence in type 2 diabetes patients” said Ravi Kumar, Ph.D., founder and CEO of ARKAY Therapeutics. “On behalf of the company, I would like to thank our scientific advisors for contributing to ARKAY’s responses to the FDA’s requests for additional information during the 30-day safety period. We are excited that this novel approach — which represents a new paradigm of treating type 2 diabetes in the context of comorbidities and coexisting conditions — has the potential to prevent or delay initiation of insulin therapy,” Dr. Kumar added. ARKAY’s patent, 9,839,644, that protects the formulations and the method used for RK-01 was issued by the U.S. Patent and Trademark Office in December 2017. A continuation patent application, publication number US-2018-0042945-A1, that protects additional formulations and methods has also been filed.
About Type 2 diabetes
Type 2 diabetes is a global epidemic, and it continues to be an unmet medical need. According to a recent publication, 48% of patients experience primary failure with metformin, the current first-line of therapy, and 52% of patients experience secondary failure with second and third add-on drugs in the United States (Montvida, O. et al. 2018, Diabetes Care). This occurs because the modalities used for current treatment options primarily treat the symptoms, but do not mitigate the underlying complex pathophysiology. RK-01 is custom-designed and formulated to block several distinct and overlapping mechanisms that contribute to the progressive deterioration of pancreatic beta-cell function, which is central to the complex pathophysiology of type 2 diabetes. Based on the results obtained from the controlled clinical and animal studies with individual component drugs, as well as combinations that contained at least one component drug in RK-01, RK-01 is expected to provide durable glycemic control by maintaining or restoring beta-cell function and more importantly, delaying or preventing insulin dependence.
About ARKAY Therapeutics
ARKAY Therapeutics is a clinical stage biopharmaceutical company located in East Windsor, NJ. ARKAY was founded on a mission to provide durable glycemic control to type 2 diabetes patients. We are dedicated to developing and commercializing personalized medicines for type 2 diabetes, prediabetes, and metabolic disease-related disorders, such as NASH (Non-alcoholic Steatohepatitis). Type 2 diabetes is characterized by the progressive deterioration of pancreatic beta-cell function and insulin resistance. In spite of intense therapies with the modalities used for currently marketed therapies, patients experience deterioration of metabolic control of glucose homeostasis, which is indicative of progressive deterioration of pancreatic beta-cell function. In a therapeutic area crowded with “me too” drugs, ARKAY’s think-outside-the-box approach treats the underlying multidimensional, complex pathophysiology, by targeting the maximum number of clinically relevant cellular defects and pathways with a minimum number of orally-active drugs in a patient-centric manner to provide durable glycemic control. ARKAY is currently raising capital for the clinical studies. For more information on how RK-01 differentiates clinically and mechanistically from currently marketed drugs and for bios of management, the board of directors, and scientific advisors, please visit www.arkaytherapeutics.com.
Ravi Kumar, Ph.D. CEO