A few days ago, ARKAY Therapeutics announced that the US FDA has accepted a new drug clinical trial (IND) application for its new diabetes drug RK-01. RK-01 is a “first-in-class” “beta-cell-centered” oral drug combination for the treatment of type 2 diabetes. It contains three components, namely metformin, valsartan and celecoxib. This clinical trial will assess the safety, tolerability, and efficacy of RK-01 in newly diagnosed patients, as well as in type 2 diabetic patients who are obese and cannot be effectively controlled by metformin alone.

Type 2 diabetes is a global epidemic, which occurs after the age of 35 to 40, accounting for more than 90% of diabetic patients, affecting more than 400 million people worldwide. Diabetes is the leading cause of blindness, kidney failure, heart attack, stroke and lower extremity amputation. In 2015, there were 1.6 million deaths directly caused by diabetes. Current treatments are primarily focused on the control of symptoms, but not targeted at curing at the potential root causes. There is still a huge unmet medical need in this area.

The unique formulation of RK-01, by adding valsartan and celecoxib to metformin, blocks several complementary mechanisms of inflammation and hyperglycemia, which lead to a gradual deterioration of islet beta cell function, which is exactly the core of complex pathophysiology of type 2 diabetes. Valsartan is an angiotensin II receptor type 1 blocker that has been approved for the treatment of hypertension. Celecoxib is a selective cyclooxygenase-2 (Cox-2) inhibitor that has been approved for the treatment of arthritis. Activation of the renin-angiotensin system (RAS) and Cox-2 in beta cells is associated with the complex pathophysiology of type 2 diabetes. Cox-2 derived pro-inflammatory prostaglandin PGE2 inhibits GLP-1 agonist-mediated glucose-dependent insulin secretion (GDIS) from beta cells. Currently, some commercially available drugs are GLP-1 agonists, but the existing treatments cannot block the damage of β-cell function caused by inflammation. While RK-01 can maintain or restore beta cells, it provides long-lasting glycemic control and even delays and prevents the use of insulin.

According to Dr. Ravi Kumar, founder and CEO of ARKAY, the approval of the RK-01 IND is an important milestone in the history of ARKAY research. RK-01 is expected to prevent metformin failure, maintain insulin sufficiency and reduce the risk of insulin dependence in patients with type 2 diabetes. This new treatment may marks the beginning of preventing or delaying insulin therapy for type 2 diabetes. At the same time, the general public also expect this innovative therapy to be validated in clinical trials will bring new relief to patients with type 2 diabetes as soon as possible.

Author's Bio: 

This article is written by scientists at Creative Peptides, a company that offers various peptides for diabetes research, including: Amylins Fragments (IAPP), Chromogranin A / Pancreastatin, Exendins Fragments, Insulin C-Peptides, Insulin-Like Growth Factors Fragments (IGF), Glucagons and Glucagon-Like Peptides (GLP-1 / GLP-2), Gastric Inhibitory Polypeptide and Fragments, Ghrelin Peptides, γ Secretase Inhibitors, β Secretase Inhibitors, etc.