Approval secured approximately six months after a 662.5 billion won licensing deal; safety to be evaluated in 88 healthy adults.
Preclinical studies demonstrate mucosal healing effects; company considers Phase 1b trials for international patients.
Daewoong Pharmaceutical announced on the 12th that it has received approval from the Ministry of Food and Drug Safety for its Investigational New Drug (IND) application for DWP309008, a candidate for inflammatory bowel disease (IBD) aimed at regenerating intestinal mucosa.
DWP309008, originally known as INV-008, was licensed from InnoTherapy in May. The company secured clinical development approval just six months after signing the licensing agreement, valued at a total of 662.5 billion won.
The Phase 1a clinical trial will involve 88 healthy adults, with Professor Lee Seung-hwan of the Department of Clinical Pharmacology at Seoul National University Hospital serving as the principal investigator. The study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DWP309008. To support future global development, the trial will include participants from diverse ethnic backgrounds.
IBD, which includes conditions such as ulcerative colitis and Crohn's disease, is a chronic, intractable disease characterized by recurring inflammation. While biologics and immunomodulators are currently used, some patients experience insufficient initial responses or diminishing efficacy over time. There remains a significant unmet medical need for long-term remission and the healing of damaged intestinal mucosa.
DWP309008 is an oral drug candidate that inhibits the enzyme 15-PGDH, which breaks down PGE2—a substance involved in the protection and recovery of the intestinal lining. By inhibiting this enzyme, the drug reduces the degradation of PGE2, thereby maintaining the protective and restorative functions of the intestinal mucosa.
Daewoong Pharmaceutical stated that preclinical studies showed high drug exposure in colon tissue and significant mucosal healing effects. The company aims to develop the drug as a best-in-class oral treatment by focusing on maximizing mucosal regeneration through sufficient drug exposure at the lesion site.
The company noted that the global IBD market is increasingly focusing on therapeutic strategies that go beyond immune and inflammatory regulation to target the recovery of damaged mucosa and the improvement of barrier function. Major global pharmaceutical companies are also actively investing in candidates that prioritize mucosal healing.
Daewoong Pharmaceutical plans to leverage the Phase 1a results to drive subsequent clinical development and global commercialization. The company is currently reviewing entry into global Phase 1b trials targeting IBD patients abroad and is exploring various commercialization paths, including company-led late-stage clinical development and global out-licensing.
Park Seong-soo, CEO of Daewoong Pharmaceutical, stated, "This Phase 1 approval is significant as it demonstrates that our licensing collaboration with InnoTherapy has successfully translated into clinical development milestones. We are committed to addressing the unmet needs of IBD patients by developing a differentiated drug that goes beyond traditional inflammation suppression to target the recovery of damaged intestinal mucosa, and we will do our utmost to ensure it grows into a global innovative medicine."
