Daewoong Pharmaceutical "Safety Verification at the 2nd IDMC Meeting"
Jul 29, 2024
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Following the first Independent Data Monitoring Committee (IDMC) meeting held in March, Versiforocin was recommended to continue clinical practice at the second meeting held on July 26. In this second IDMC meeting, an in-depth review of the safety data of Versiforocin in a total of 59 enrolled patients, including 51 patients with idiopathic pulmonary fibrosis who completed clinical trials, found no significant problems.
IDMC will conduct a final inspection of the safety of phase 2 clinical trials of Versiforocin at the third meeting scheduled early next year. Phase 2 clinical trials are planned to be completed within 2025.
Idiopathic Pulmonic Fibrosis (IPF) is an incurable disease in which collagen accumulates abnormally in the lungs and loses lung function, and is a fatal disease with a poor prognosis, with a 5-year survival rate of only 40% after diagnosis.
Versiforocin is expected to show safety and efficacy differentiated from conventional treatments through a novel mechanism of action that directly inhibits collagen synthesis. Safety and pharmacokinetic characteristics were identified in healthy people in phase 1 clinical trials. Phase 2 clinical trials are conducted in patients with idiopathic pulmonary fibrosis over 40 years of age, and patients who are currently taking or discontinued the approved treatment are participating.
The 24-week clinical trial evaluates the safety, tolerability, and efficacy of verciporocin alone and combination therapy with conventional treatments. Phase 2 clinical trials, which began in the U.S. and South Korea in January 2023, are cruising, recruiting 61 patients to date, achieving approximately 60% of the target number of 102. Domestic clinical trials are being conducted in 10 locations, including Seoul Asan Hospital, Sinchon Severance Hospital, Seoul Samsung Hospital, Soonchunhyang University Bucheon Hospital, Bucheon St. Mary's Hospital, Ajou University Hospital, Myongji Hospital, Ulsan University Hospital, and Inje University Busan Paik Hospital.
Lee Chang-jae, CEO of Daewoong Pharmaceutical, said, "This IDMC's recommendation is an important milestone in the smooth development of Versiforocin. We will do our best to provide new treatment options to patients with idiopathic pulmonary fibrosis through the development of Versiforocin, a candidate for an innovative new drug." he said.
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