Daewoong Pharmaceutical announced that it has received approval from the Ministry of Food and Drug Safety for its Phase 1 clinical trial plan (IND) for the inflammatory bowel disease treatment candidate 'DWP309008' on November 12. This marks a significant milestone just six months after the company entered into a contract with Innovo Therapeutics worth 662.5 billion won in May.
Inflammatory bowel disease is a chronic condition characterized by recurring inflammation in the intestines, with ulcerative colitis and Crohn's disease being the most common forms. Some patients do not respond adequately to initial treatments, or the effectiveness diminishes over time. Maintaining a long-term symptom-free state and repairing damaged intestinal mucosa remain unmet medical needs.
DWP309008 is an oral drug candidate that operates through a different mechanism than existing treatments. It inhibits the enzyme '15-PGDH,' which breaks down PGE2, a substance involved in protecting and repairing the intestinal mucosa. By inhibiting this enzyme, the breakdown of PGE2 is reduced, helping to maintain protective and restorative functions of the intestinal mucosa and promoting the regeneration of damaged tissue. The drug is designed to ensure sufficient delivery to the affected areas. Preclinical studies have shown high drug exposure in colon tissues and healing effects on the intestinal mucosa. Daewoong Pharmaceutical plans to develop it as a best-in-class oral medication within the same class.
The Phase 1a trial will involve 88 healthy adults, with Professor Lee Seung-hwan from Seoul National University Hospital serving as the principal investigator to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD). The study will also include participants from diverse ethnic backgrounds to facilitate global clinical applications.
Based on the results of Phase 1a, Daewoong Pharmaceutical is considering entering Phase 1b trials targeting patients with inflammatory bowel disease overseas. The company plans to explore commercialization strategies, including its own late-stage clinical development and global technology exports.
Daewoong Pharmaceutical CEO Park Sung-soo stated, "The approval of this Phase 1 trial is significant as it demonstrates that our collaboration with Innovo Therapeutics has led to tangible clinical development outcomes. We will strive to contribute to addressing the unmet medical needs of patients with inflammatory bowel disease through the development of differentiated new drugs aimed at repairing damaged intestinal mucosa and to grow as a global innovative pharmaceutical company."
Meanwhile, Daewoong Pharmaceutical reported a standalone revenue of 415.8 billion won for the third quarter, a 17.1% increase compared to the same period last year. Operating profit rose by 43.5% to 76.8 billion won, with an operating profit margin of 18.5%.
The key growth driver was 'Nabota.' In the third quarter, Nabota sales reached a record high of 116.3 billion won, combining domestic and international markets. Of this, export sales amounted to 106.8 billion won, a 127.9% increase compared to the previous year.
* This article has been translated by AI.
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