NIH to Fund Clinical Trials

Dong-A ST announced on Sept. 22 that the U.S. Food and Drug Administration (FDA) has approved phase 2b/3a clinical trials for repositioning of its diabetes treatment Suganon (component name: Evogliptin) as a medication for calcific aortic valve disease (CAVD), which currently has no other remedy.

The clinical trials will be carried out by REDNVIA, a pharmaceutical company jointly set up by Dong-A ST and Seoul Asan Hospital, at U.S. hospitals including Mayo Clinic and Massachusetts General Hospital, an hospital affiliated with Harvard Medical School.

REDNVIA plans to receive funds for clinical research from the National Institutes of Health (NIH) and closely cooperate with researchers of these institutions to expedite product commercialization.

REDNVIA filed an investigational new drug (IND) application with the Korean Ministry of Food and Drug Safety in June 2019 and has been conducting a phase 2 clinical trial on 225 patients in Korea, and filed a phase 2b/3a IND application with the U.S. FDA in July.

In January 2019, Dong-A ST transferred its Suganon technology to REDNVIA to reposition the already approved and widely used anti-diabetes drug as a treatment for CAVD.

Meanwhile, REDNVIA is considering discovering a candidate material for a composite drug to develop Suganon as a treatment for nonalcoholic steatohepatitis (NASH) as well as CAVD.

Copyright © BusinessKorea. Prohibited from unauthorized reproduction and redistribution