Daewoong Pharmaceutical Announces US FDA Clearance of IND Application for DWP213388, First-in-class Irreversible Oral Dual Acting Inhibitor for Autoimmune Diseases 

DWP213388 is a first-in-class dual-target inhibitor that simultaneously inhibits 
pathogenic T cells and B cells across a range of autoimmune disease

August 15, 2022, Daewoong Pharmaceutical is a publicly traded South Korean pharmaceutical company that develops, manufactures, and commercializes pharmaceuticals globally today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to initiate a Phase 1 clinical trial of DWP213388, a new drug candidate being developed for autoimmune diseases. 
 
Daewoong Pharmaceutical CEO Seng-ho Jeon said, “Daewoong Pharmaceutical plans to lead the development of various global new drugs such as DWP213388 in collaboration with global licensees for patients with autoimmune diseases” and he added that "We will contribute to improving the quality of life of many patients around the world who are suffering from lack of a cure."

The planned Phase 1 clinical trial is a double-blind, randomized, placebo-controlled, a single and multiple doses escalation study in 80 healthy subjects.  It will assess the safety, pharmacokinetics and pharmacodynamic responses of DWP213388 as a first-in-class strategy to treat autoimmune.  The trial is projected to initiate in 2H 2022 in the USA. 
 
Unlike current treatments, which are generally limited to inhibiting only B cells or T cells, DWP213388 is a dual-target inhibitor that simultaneously inhibits B cells and T cells, thus has higher efficacy potential than conventional single-action treatments. It selectively inhibits both Bruton's Tyrosine Kinase (BTK) and Interleukin-2-inducible T-cell Kinase (ITK).  Daewoong has demonstrated that this dual activity was safe and effective at preventing or reducing autoimmune pathology in a number of preclinical models.

According to Research And Markets, a global market research institute, the global autoimmune disease treatment market is growing at an average annual rate of 4.2% and is expected to reach $153 Billion (about 200 Trillion KRW) by 2025. 
 

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Notes to editor:
The immune cells of our body interact to attract or activate other cells of the immune system, either directly or indirectly. Since most autoimmune disease patients, especially B cells and T cells are excessively activated, targeting BTK and ITK simultaneously and inhibiting the activation of B cells and T cells at the same time can effectively suppress the symptoms of autoimmune disease. 
Autoimmune disease occurs when the internal immune system recognizes and attacks normal cells inside the body as antigens, although they are not external antigens such as bacteria and viruses. Therefore, it is expected that it will help to solve the unmet medical needs of autoimmune diseases.