Daewoong Pharmaceutical will enter a Phase 1 clinical trial for its inflammatory bowel disease treatment candidate, 'DWP309008.' The goal is to develop it as the best oral agent within its group.
On Thursday, the company said that DWP309008 received approval from the Ministry of Food and Drug Safety for a Phase 1 clinical trial plan (IND).
DWP309008 is the new drug candidate 'INV-008' that Daewoong Pharmaceutical introduced from InnoB Therapeutics last May. Approximately six months after signing a technology transfer contract worth 662.5 billion won, Daewoong Pharmaceutical secured approval to enter clinical trials.
Inflammatory bowel disease is a refractory condition characterized by chronic inflammation in the intestine that alternates between remission and exacerbation, with ulcerative colitis and Crohn's disease being representative examples.
Currently, various treatments such as biological agents and immunomodulators are used, but some patients face limitations where initial treatment response is insufficient or drug efficacy decreases over time. In particular, maintaining long-term remission and healing damaged intestinal mucosa remain significant unmet medical needs.
DWP309008 is a new oral drug candidate with a novel mechanism that inhibits 15-PGDH, an enzyme that breaks down PGE2, a substance involved in the protection and recovery of intestinal mucosa.
Inhibiting the action of 15-PGDH reduces the breakdown of PGE2 in the body, allowing the protective and regenerative effects on intestinal mucosa to be maintained. DWP309008 is designed to promote the regeneration of damaged intestinal mucosa by utilizing this principle.
DWP309008 is being developed with the goal of ensuring sufficient drug exposure at lesion sites to enhance mucosal regeneration effects. In preclinical studies, high drug exposure in colonic tissue and intestinal mucosal healing effects were observed.
Based on these research results, Daewoong Pharmaceutical plans to pursue the development of a global best-in-class oral new drug within its group.
This Phase 1a trial will be conducted with 88 healthy adults, with Professor Lee Seung-hwan from the Department of Clinical Pharmacology at Seoul National University Hospital serving as the principal investigator (PI).
The clinical trial is expected to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of DWP309008. To secure safety and pharmacokinetic data from diverse populations that can be utilized for global clinical development, the plan is to conduct the trial including subjects of various ethnicities.
Daewoong Pharmaceutical intends to actively push forward with subsequent clinical development and global commercialization based on the Phase 1a results.
It is considering entering a global Phase 1b trial targeting inflammatory bowel disease patients overseas. The company plans to explore various commercialization strategies, including late-stage clinical development led by Daewoong Pharmaceutical and global technology licensing.
Park Seong-su, CEO of Daewoong Pharmaceutical, said, "This Phase 1 approval is significant in that the technology transfer collaboration with InnoB Therapeutics has led to actual clinical development results."
He added, "Through the development of a differentiated new drug that goes beyond existing inflammation-suppression-focused treatments to target the recovery of damaged intestinal mucosa, we will strive our best to contribute to resolving the unmet medical needs of inflammatory bowel disease patients and grow it into a global innovative new drug."
in THEBIO
