Daewoong Pharmaceutical: "Inflammatory Bowel Disease Drug Candidate Enters Phase 1 Trial"
About six months after the technology licensing agreement
Daewoong Pharmaceutical said on November 12 that its inflammatory bowel disease drug candidate, DWP309008, had received approval from the Ministry of Food and Drug Safety for a Phase 1 clinical trial plan (IND). The Phase 1a trial will involve 88 healthy adults, with Lee Seunghwan, a professor in the Department of Clinical Pharmacology at Seoul National University Hospital, serving as the principal investigator (PI).
DWP309008 is a drug candidate that Daewoong Pharmaceutical licensed from Innobo Therapeutics in May. Inflammatory bowel disease is a hard-to-treat condition in which chronic inflammation in the intestines alternates between improvement and flare-ups. Although various treatments, including biologics and immunomodulators, are currently available, some patients do not respond adequately to initial treatment, while others experience a decline in efficacy over time.
DWP309008 is an oral drug candidate with a novel mechanism of action that inhibits 15-PGDH, an enzyme that breaks down PGE2, a substance involved in protecting and repairing the intestinal mucosa. By inhibiting 15-PGDH, the drug reduces the breakdown of PGE2 in the body, potentially maintaining its protective and restorative effects on the intestinal mucosa. DWP309008 was designed to use this mechanism to promote the regeneration of damaged intestinal mucosa.
Daewoong Pharmaceutical is considering advancing the candidate into a global Phase 1b trial involving patients with inflammatory bowel disease overseas. The company plans to explore various commercialization strategies, including later-stage clinical development led by Daewoong Pharmaceutical and global technology licensing deals.
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Park Seongsu, CEO of Daewoong Pharmaceutical, said, "We will do our utmost to help address the unmet medical needs of patients with inflammatory bowel disease and develop this into a globally innovative drug through differentiated drug development that goes beyond treatments focused on suppressing inflammation and also aims to repair damaged intestinal mucosa."
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