[Asia Economy Reporter Cho Hyun-ui] Dong-A ST announced on the 22nd that Redenvia has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application to conduct a Phase 2b/3a clinical trial in the United States to develop the diabetes treatment drug ‘Sugannon’ (active ingredient Evogliptin) as a treatment for aortic valve calcification.
Redenvia is a joint venture established by licensing the substance patent of Sugannon, a diabetes treatment developed by Dong-A ST, and the use patent for aortic valve calcification treatment from Seoul Asan Medical Center.
The clinical trial will involve top U.S. hospitals, including the Mayo Clinic, selected as the best hospital in the U.S. from 2020 to 2021, and Massachusetts General Hospital, affiliated with Harvard Medical School.
Redenvia plans to accelerate product commercialization through close collaboration with these researchers and by receiving clinical research funding from the U.S. National Institutes of Health (NIH).
Previously, Redenvia received approval for a domestic Phase 2 clinical trial for aortic valve calcification in June last year and has been conducting the trial with 225 patients. In July, it applied to the FDA for a Phase 2b/3a clinical trial.
Um Dae-sik, Chairman of Dong-A ST, stated, "This Sugannon clinical trial is being conducted through drug repositioning of a successfully developed new drug, aiming for early commercialization to help patients suffering from aortic valve calcification, for which there is no treatment. We will closely cooperate to ensure Redenvia successfully completes the development of the treatment."
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