2024-07-30 10:03:29
Clinical Safety Verification at IDMC 2nd Meeting
Innovative new drug Versiforosin, mechanism of inhibition of collagen synthesis that causes pulmonary fibrosis
Versiforosin safety confirmed by IDMC
Domestic Phase 2 clinical trial patient recruitment in progress… Target for completion of Phase 2 clinical trial next year
Daewoong Pharmaceutical announced on the 29th that its idiopathic pulmonary fibrosis treatment drug ‘Versifolocin (DWN12088),’ which is being developed as the world’s first new drug (first-in-class), has been verified for safety in global phase 2 clinical trials. This is considered to be one step closer to the development and commercialization of a new drug for pulmonary fibrosis.
Versiforosin received a recommendation to continue the clinical trial at the second meeting held on the 26th of this month, following the first Independent Data Monitoring Committee (IDMC) meeting held in March. It is said that this second IDMC meeting focused on in-depth review of safety data for a total of 59 patients, including 51 patients with idiopathic pulmonary fibrosis who completed the clinical trial. As a result, no significant problems were found. The IDMC plans to conduct a final safety review of the phase 2 clinical trial of Versiforosin at the third meeting early next year. The goal is to complete the phase 2 clinical trial by next year.
Idiopathic pulmonary fibrosis (IPF) is an incurable disease in which collagen is abnormally accumulated in the lungs, causing loss of lung function. It can be understood as the lungs hardening. It is considered a fatal disease with a poor prognosis, with a 5-year survival rate of only 40% after diagnosis. Representative existing treatments include Esbriet (ingredient: pirfenidone) developed by Roche in Switzerland and Ofev (ingredient: nintendanib) by Boehringer Ingelheim in Germany. However, it is known that the efficacy is limited to slowing down the progression of fibrosis, and the incidence of adverse reactions is also high. It can still be seen as an area with high unmet needs.
Daewoong Pharmaceutical’s Versiforosin is characterized by a new mechanism that directly inhibits collagen synthesis. It is expected to have safety and efficacy differentiated from existing treatments. In phase 1 clinical trials, safety and pharmacodynamic characteristics were confirmed in healthy subjects. Phase 2 clinical trials will be conducted on patients with idiopathic pulmonary fibrosis aged 40 years or older. Patients who are currently taking or have stopped taking approved treatments are participating as clinically registered patients. The clinical trial will be conducted for 24 weeks. The goal is to evaluate the safety, tolerability, and efficacy of Versiforosin alone and combination therapy with existing treatments. Phase 2 clinical trials, which began in the US and Korea in January of last year, have recruited 61 patients so far. Approximately 60% of the target number of patients (102) has been achieved. Domestic clinical trials are being conducted at 10 locations: Seoul Asan Medical Center, 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 recommendation is an important milestone that proves the safety of versiphorosin,” and added, “We will do our best to provide a new treatment option for patients with idiopathic pulmonary fibrosis through the development of versiphorosin, an innovative new drug candidate.”
Versiforosin was designated as an orphan drug by the U.S. Food and Drug Administration (FDA) in 2019, and was later selected as a fast-track development item in 2022. In January of this year, it was designated as an orphan drug by the European Medicines Agency (EMA). Last year, it signed a technology export contract with CS Pharmaceuticals of the UK to the Greater China region, and is also pursuing entry into the global market.
Kim Min-beom, Donga.com reporter [email protected]
-
- great
- 0dog
-
- I’m so sad
- 0dog
-
- I’m angry
- 0dog
-
- I recommend it
- dog
Hot news right now
2024-07-30 10:03:29