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Clinical PoC in COVID-19 patients

Cox-2 activation Image in human T2D islets

Human proof-of-concept (PoC): Immunofluorescence with Cox-2 (red) and DAPI (blue). Cox-2 is elevated in pancreatic islets of Type 2 diabetes (T2DM) patients compared to human islets isolated from patients without T2DM (ND). 


Mission Statement

Change The Current Type 2 Diabetes Disease Trajectory of Failure Of First, Second And Third Line of Therapies, Clinical Inertia, Insulin Dependence and Diabetes Complications

Develop TriGlytza™ For Treating Acute Repiratory Distress Syndrome (ARDS) associated with COVID-19 



Care Award Finalist
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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 RAAS-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.


"Get Real and Get It Right" with Type 2 Diabetes and Human PoC

"It is now time for a paradigm shift in the treatment of Type 2 diabetes by assessing the individual patient’s risk by determining the inflammatory status and develop drugs that not only sustain the beta cell function but can also be evaluated as a prophylactic therapy."

Ravi Kumar, Ph.D. Founder and CEO
Articles were shared on LinkedIn, March 27 and September 10, 2019

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Value, Mitigation of Risk & Competitive Edge

In spite of the development of drugs for newer modalities such as GLP-1s, DPP4 inhibitors, and SGLT2 inhibitors, Metformin continues to be the "Gold Standard" and the foundation medicine for Type 2 diabetes patients. TriGlytza™ adds value by preventing the primary failure with Metformin therapy and the  clinical inertia that occurs after Metformin failure. ARKAY has mitigated the risk to a great extent because the component add-on drugs in TriGlytza™ have already shown efficacy in preserving beta cell function in the setting of insulin resistance in controlled clinical studies. They also have a track record of safety for chronic use in Type 2 diabetes patients.TriGlytza™ is expected to have a competitive edge based on clinical differentiation and pricing.

Counter-Regulation of RAAS-AngII-PGE2 Axis for Treatment of COVID-19

"This science based approach with clinical PoC makes perfect sense in light of limited therapeutic options for treatment and mitigation of  ARDS and MODS associated with COVID-19."

Ravi Kumar, Founder and CEO Article shared on Linkedin on October 5, 2021.

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Striving to End the Epidemic of Type 2 Diabetes

Medicine Tablets

Right now, there are no anti-inflammatory 'Beta-cell-centric' therapies on the market for Type 2 diabetes. Our novel & innovative beta-cell centric product, RK-01 or TriGlytza™ restored the  efficacy of Metformin in C57BL/6J DIO mice with insulin resistance and pancreatic beta-cell dysfunction. We are on track to bring TriGlytza™ to market by 2026.

MEDICINE
Medicine

ARKAY is advancing the ParamAushadam® (derived from Sanskrit, it means "Perfect Medicine" in English) platform by combining drugs at the appropriate doses along with predetermined modified drug release to achieve optimal therapeutic as well as kinetic synergies.

PARAMAUSHADAM®
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Discover why now is the best time to partner and collaborate with our biopharmaceutical company. ARKAY Therapeutics is focused on setting the standard for medicine and treatment of Type 2 diabetes and related disorders such as NASH by advancing an innovative 'Beta-cell-centric' platform.

FOR INVESTORS

Invest in a healthier future by becoming a key stakeholder today at ARKAY Therapeutics

Call (609) 362-6818


About Us

With the numbers and cases of diabetes always on the rise with no end in sight, our biopharmaceutical company in East Windsor, New Jersey, decided to take action and do something about this global epidemic. Today, ARKAY Therapeutics is dedicated to developing and commercializing innovative medicines for Type 2 diabetes.

More than 370 million people worldwide and 26 million people in the U.S. alone suffer from Type 2 diabetes. The disease is not successfully controlled in almost 50% of patients, according to the American Diabetes Association.

The potential impact of our diabetes medicine has enormous medical and financial implications. This is an avenue that investors can’t afford to miss.

Learn More About ARKAY Therapeutics


More Than 30 Years of BioMedical Experience


Contact

Thank you for your interest. For questions or comments, please use the information listed here. We look forward to hearing from you soon.

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