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.
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