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RK-01: PoC in a Translational Mouse Model

Study results were presented at the 76th Scientific Sessions of the American Diabetes Association, June 10-14, 2016, New Orleans, LA.

Anti-inflammatory 'Beta-cell centric' Drug Combination Lowered Non-fasting and Fasting Blood Glucose Levels and Improved Glucose Tolerance in C57BL/6J DIO Mice With Insulin Resistance and Beta-cell Dysfunction*

* Study was performed with USP Grade, finished product-ready APIs

"Looks Promising"
Marc Donath, MD
Head of the Clinic for Endocrinology, Diabetes, and Metabolism
Department of Biomedicine
University Hospital, Basel, Switzerland
Expert in the role of pancreatic islet inflammation in Type 2 diabetes


Validation of ARKAY's Product Concept

Human PoC of Treating Type 2 Diabetes with Valsartan

Valsartan monotherapy has been shown to improve beta-cell function and insulin sensitivity in patients with impaired glucose tolerance (IGT).

Dual Combination of Valsartan and Sacubitril lowered A1c, persistently maintained lowered A1c and more importantly, 29% fewer patients initiated insulin therapy over a period of 3.2 years.

PARADIGM-HF trial

Human PoC of Treating Type 2 Diabetes with Celecoxib

Dual combination of Celecoxib and Glimepiride improved beta-cell function, glycemic, inflammatory, and lipid parameters better than Glimepiride alone in obese Type 2 diabetes patients.

"Impressive - full speed ahead!"
Stan Schwartz, MD

Renowned endocrinologist who developed the 'Beta-cell-centric' concept for reclassification and efficient treatment of diabetes 


Cardiovascular (CV) Safety of Celecoxib for Chronic Use

Results from the landmark PRECISION trials indicate that CV, GI and renal risks associated with long term use of Celecoxib is low and it is safer than other NSAIDs such as Naproxen and Ibuprofen in patients with CV risk. Clinical trial results were presented at the Scientific Sessions of the American Heart Association, November 12-16, 2016 in New Orleans, LA.

"After the withdrawal of rofecoxib, there ensued a rush to judgement about the cardiovascular safety of Cox-2 inhibitors. Fueled by the controversy and some experts commentary used observational data, small RCTs and theoretical concerns to 'confirm' what they expected. The PRECISION trial demonstrates the hazards inherent in prejudgment about the risks and benefits of therapies based upon expectations and indirect methods. These findings serve as an important warning to the medical community that we may arrive at erroneous conclusion when we fail to follow a systematic and unbiased approach to scientific and public health questions".

Steven Nissen, MD
Principal Investigator, PRECISION Trial
Chairman, Cardiovascular Medicine
The Cleveland Clinic Foundation
November 13, 2016 AHA's Scientific Sessions, New Orleans, LA

April 25, 2018: The FDA's Arthritis Advisory Committee (AAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) voted by a large margin (15:5) that the CV safety of Celecoxib is comparable to Naproxen and Ibuprofen.

PRECISION Trial Research Paper


Diabetes

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Why Now Is the Time to Partner & Collaborate

Currently, there are no anti-inflammatory 'Beta cell-centric' therapies on the market. This is why the opportunity to capitalize on this cutting-edge medicine is so great.

Our lead combination product, RK-01 was efficacious and safe in the preclinical PoC studies performed using C57BL/6J DIO (Diet-induced obesity) mice with pancreatic beta-cell dysfunction and insulin resistance*.

More importantly, ARKAY's product concept has been validated by human PoC for using combinations that contain Valsartan or Celecoxib for treating Type 2 diabetes. 

ARKAY Therapeutics has established fully protected intellectual space for advancing anti-inflammatory 'Beta-cell-centric' therapies. U.S. patent 9,839,644 "Formulations and Methods for Treatment of Metabolic Syndrome” was issued on December 12, 2017. They describe in detail over 60 formulations and methods for treating Type 2 diabetes, prediabetes and metabolic disease-related disorders. A continuation patent application (Publication Number: US-2018-0042945-A1) has  been filed  to protect several additional formulations and methods.

Gain a more in-depth view of our organization and the kinds of medication we’re creating by clicking here.

*ARKAY has been operating as a virtual company by collaborating with leading CROs


Type 2 Diabetes by the Numbers

Type 2 diabetes is a pandemic and the patient population is expected to double to over 600 million world-wide and over 40 million in the United States by 2040 (IDF, Facts & Figures). The prevalence of Prediabetes is three times that of Type 2 diabetes.  In 2012, 86 million Americans age 20 or older had prediabetes (American Diabetes Association). The global Type 2 Diabetes market will grow from $20.4 billion in 2012 to $58.7 billion in 2025 (FiercePharma). The global market for Metabolic Syndrome is estimated to be $72.4 billion by 2018 (Biovision). 

Diabetes Statistics
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Diabetes-Related Complications
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Understand Our Company

As a savvy investor, we understand that you’re not going to take a risk without knowing every past, present, and future aspect of our biopharmaceutical company. That’s why we invite you to get to know us and gain a sense of our potential.

Upon request, we provide the Executive Summary and the Business Plan that will cover all the information you need to make a smart, well-informed investment decision. Take a moment to read about our founder, president and CEO, Dr. Ravi Kumar by clicking here.

ARKAY has developed a low-to-moderate risk business plan to develop and commercialize an innovative product that differentiates clinically and mechanistically for a pandemic with an enormous market potential in 4 to 5 years with a potential exit strategy in 2 to 3 years.