Daewoong Pharmaceutical Co., Ltd. enters Phase 1 trial for inflammatory bowel disease drug candidate; pursues global trials and technology out-licensing

[Financial News] Daewoong Pharmaceutical Co., Ltd. is moving ahead in earnest with clinical development of a drug candidate for inflammatory bowel disease. The drug candidate, licensed in from a domestic biotech company last May, has entered the clinical stage in about six months, accelerating the expansion of the company’s drug pipeline through open innovation.
Daewoong Pharmaceutical Co., Ltd. said on the 12th that its inflammatory bowel disease drug candidate DWP309008 had received approval from the Ministry of Food and Drug Safety (MFDS) for its Phase 1 investigational new drug (IND) application.
DWP309008 is the candidate INV-008, which Daewoong Pharmaceutical Co., Ltd. licensed in from Inovo Therapeutics last May. At the time, the two companies signed a technology licensing-in agreement worth a total of 662.5 billion won. Daewoong secured approval to advance the candidate into clinical trials about six months after licensing it in.
DWP309008 works by inhibiting the breakdown of prostaglandin E2 (PGE2), a substance involved in protecting and restoring the intestinal mucosa. It is designed to maintain PGE2 levels in the body and promote the regeneration of damaged intestinal mucosa by inhibiting 15-PGDH, the enzyme that breaks down PGE2.
Inflammatory bowel disease is a chronic condition, with ulcerative colitis and Crohn’s disease among its main forms. Existing treatments have largely focused on suppressing inflammation using biologics and immunomodulators. However, some patients do not respond sufficiently to initial treatment, or the drugs’ effectiveness wanes over time. Maintaining long-term remission and restoring damaged mucosa are also considered major unmet needs.
Daewoong Pharmaceutical Co., Ltd. aims to differentiate the drug from existing treatments through a mechanism for regenerating the intestinal mucosa, distinct from suppressing inflammation. Preclinical studies confirmed high drug exposure in colon tissue and an intestinal mucosal healing effect. A key focus of development is ensuring that enough of the drug reaches affected areas to enhance mucosal recovery.
This Phase 1a trial will be conducted at Seoul National University Hospital (SNUH) with 88 healthy adults. Seung Hwan Lee, a professor in SNUH’s Department of Clinical Pharmacology, will serve as the principal investigator. The trial will assess the drug’s safety and tolerability, as well as its pharmacokinetic (PK) and pharmacodynamic (PD) properties. The company also plans to include participants of various ethnicities to gather data for future global trials.
Daewoong Pharmaceutical Co., Ltd. will pursue further development based on the Phase 1a results. It is considering moving into a global Phase 1b trial involving inflammatory bowel disease patients overseas, and plans to explore various commercialization options, including later-stage clinical development and global technology out-licensing.
Park Sung-su, CEO of Daewoong Pharmaceutical Co., Ltd., said, “This Phase 1 approval is significant because our technology licensing-in collaboration with Inovo Therapeutics has translated into tangible clinical development results,” adding, “We will work to address the unmet needs of patients with inflammatory bowel disease by developing a new drug that also aims to restore the intestinal mucosa.”

[email protected] Jung Sang-hee Reporter