Daewoong Pharmaceutical Receives US FDA Approval for Phase 1 Clinical Trial of New Autoimmune Disease Drug

[Asia Economy Reporter Lee Gwanju] Daewoong Pharmaceutical announced on the 11th that it has received approval from the U.S. Food and Drug Administration (FDA) for the clinical phase 1 trial plan (IND) of the autoimmune disease new drug candidate 'DWP213388'.

In this phase 1 clinical trial, the safety, tolerability, pharmacokinetics, and pharmacodynamics characteristics of DWP213388 will be evaluated, aiming to secure the possibility of entering phase 2 clinical trials for efficacy exploration. The trial is scheduled to start in the fourth quarter of this year and will be conducted with 80 healthy adults through single and multiple dosing.

DWP213388 is an innovative new drug being developed by Daewoong Pharmaceutical as an oral treatment for autoimmune diseases. Unlike existing treatments that generally inhibit only B cells or T cells individually, it is being developed as a dual-target inhibitor that simultaneously inhibits both.

Autoimmune diseases occur when the body's immune system recognizes normal cells inside the body as antigens instead of external antigens such as bacteria or viruses and attacks them. According to the global market research firm Research and Markets, the global autoimmune disease treatment market is growing at an annual rate of 4.2% and is expected to reach $153 billion (approximately 200 trillion KRW) by 2025.

Jeon Seung-ho, CEO of Daewoong Pharmaceutical, stated, “Daewoong Pharmaceutical plans to lead the development of various global new drugs including DWP213388 for autoimmune disease patients,” adding, “We will contribute to improving the quality of life for many patients worldwide who suffer due to the lack of treatments.”