Research & Development
Daewoong Pharmaceutical's DWP213388 receives US FDA clinical trial approval
16 August 2022 -

Daewoong Pharmaceutical (069620.KS), a South Korea-based pharmaceutical company, announced on Monday that it has received US FDA approval for its Investigational New Drug (IND) application to commence a phase one clinical trial of DWP213388, a new drug candidate being developed for autoimmune diseases.

The product, a first-in-class dual-target inhibitor, simultaneously inhibits pathogenic T cells and B cells across a range of autoimmune disease.

The proposed Phase one clinical trial, a double-blind, randomised, placebo-controlled, single and multiple doses escalation study, is being conducted in 80 healthy participants. It is to evaluate the safety, pharmacokinetics and pharmacodynamic responses of DWP213388 as a first-in-class strategy to treat autoimmune disease. The trial is expected to commence in the USA in the second half of 2022.