ARKAY Therapeutics’ Announces Notice Of Allowance Of Patent Application For First-In Class “Beta-Cell-Centric” Drug, RK-01 For Type 2 Diabetes From The United States Patent Office

Published: Oct 02, 2017

East Windsor, NJ – ARKAY Therapeutics, LLC, a privately held pre-IND stage biopharmaceutical company developing innovative pancreatic “Beta-cell-centric” products for Type 2 diabetes has announced that it has received Notice of Allowance from the U.S. Patent Office for its patent application USSN 15/063,000. The claims are directed at methods and formulations used for its innovative first-in-class “Beta-cell-centric” combination product, RK-01. RK-01 is a combination of Valsartan plus Celecoxib dual add-on to Metformin. Metformin is the current first line of therapy for Type 2 diabetes patients. The component drugs in RK-01 block complementary inflammatory and hyperglycemic mechanisms in Type 2 diabetes patients. Valsartan is an Angiotensin II receptor Type 1 blocker; it is currently approved for high blood pressure. Celecoxib is a selective Cox-2 inhibitor; it is currently approved for arthritis. Valsartan and Celecoxib are being repurposed for the Type 2 diabetes space.

“This is a major milestone for ARKAY; we plan to file additional U.S. and international patents in the next couple of years to protect the methods and proprietary formulations for our ‘Beta-cell-centric’ drug combination platform for developing personalized medicines to treat patient-specific comorbidities in Type 2 diabetes patients” said Dr. Ravi Kumar, Ph.D., founder and CEO of ARKAY Therapeutics. Dr. Kumar is the sole inventor on this patent, which is currently assigned to ARKAY Therapeutics.

Type 2 diabetes continues to be an unmet medical need. In spite of many treatment options and modalities, almost 50% of patients do not meet their target goals for the “ABCs of diabetes care.” The ABCs of diabetes care are A1c, blood pressure, and cholesterol. Unlike the currently marketed drugs that primarily treat symptoms, RK-01 is custom-designed and formulated to block several distinct and overlapping mechanisms that contribute to progressive deterioration of pancreatic beta-cell function, which is central to the complex pathophysiology of Type 2 diabetes. Based on the results from the controlled clinical studies and animal studies with combinations of component drugs, RK-01 is expected to provide long-term sustainable glycemic control by maintaining or restoring beta-cell function and more importantly, delay or prevent insulin dependence. “We’re pleased ARKAY has procured this patent approval for a combination product designed specifically to fit into our ‘Beta-cell-centric’ classification of diabetes for the potential benefit to many of our patients. Each component drug in RK-01 has unique properties to maintain or restore beta-cell function, improve glycemic parameters, and treat coexisting conditions, such as NASH and arthritis. We note, as brought out in our Unified Pathophysiologic Approach to Diabetes and its Complications (published in June this year), that RK-01 has the potential to reduce complications of diabetes in these patients as well.” said Dr. Stan Schwartz, MD. Dr. Schwartz is a renowned endocrinologist and an emeritus associate clinical professor at University of Pennsylvania. He developed the concept of the “Beta-cell-centric” approach for reclassifying diabetes, as well as for efficient clinical management of diabetes. He is currently in private practice in Ardmore, PA. Dr. Schwartz serves as the medical advisor on ARKAY’s Scientific Advisory Board.

ARKAY is collaborating with Albany Medical College in Albany, NY, to conduct an investigator-initiated proof-of-concept (PoC) clinical study to evaluate the superiority of RK-01 over Metformin in Type 2 diabetes patients with inadequate glycemic control. Dr. Robert Busch, MD., an endocrinologist and diabetes expert will serve as the principal investigator of the 26-week, four-arm, randomized, active controlled clinical study. Dr. Busch has served as the principal investigator of over 40 clinical studies. Doses of the component drugs selected for the clinical study have a track record of safety for chronic use in Type 2 diabetes patients.

ARKAY has also received Notice of Allowance for its orally-active drug combination platform “ParamAushadamTM,” USSN 86864656 from the U.S. Trademark Office. “ParamAushadamTM” is derived from the ancient Indian language, Sanskrit; it means “perfect medicine.” It is a pharmaceutical methods and formulations platform that combines therapeutically efficacious doses of drugs with predetermined modified drug release formulations – to achieve optimal therapeutic synergies by sparing dose-limiting adverse side effects and potential drug-drug interactions for the treatment of obesity-triggered diseases, such as diabetes.

About ARKAY Therapeutics

ARKAY Therapeutics is a privately-held pre-IND stage biopharmaceutical company located in East Windsor, NJ. 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 progressive deterioration of pancreatic beta-cell dysfunction and insulin resistance. In spite of intense therapies with the modalities used for the currently marketed therapies, patients experience deterioration of metabolic control of glucose homeostasis, which is indicative of progressive deterioration of pancreatic beta-cell dysfunction. Lack of adequate glycemic control prevents almost 50% of the patients from reaching their target goals for blood glucose (HbA1c), blood pressure, and cholesterol levels. Inflammation-mediated pancreatic beta-cell dysfunction triggers insulin resistance. ARKAY was founded with a mission to develop orally-active combination products that would target the maximum number of clinically relevant pathways that contribute to deterioration of pancreatic beta-cell function with a minimum number of drugs in order to provide long-term sustainable glycemic control, treat patient-specific comorbidities, and more importantly, prevent or reduce the severity of diabetes-related complications. ARKAY is currently raising capital to advance an orally-active combination product, RK-01, to the clinic. RK-01 fills clinically the most important gap that exists in the modalities by blocking multiple distinct and overlapping signaling pathways along the immune dysregulation-inflammation-insulin resistance axis. For more information on how RK-01 differentiates clinically and mechanistically from currently marketed drugs, and for bios of the management, the board of directors, and the scientific advisors, please visit www.arkaytherapeutics.com.

Media Contact:
Ravi Kumar, Ph.D.
CEO
(609) 977-1857
ravi.kumar@arkaytherapeutics.com

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