DWN12088, Daewoong Pharmaceutical’s new drug for pulmonary fibrosis, enters global clinical studies phase 1.

DWN12088, Daewoong Pharmaceutical’s new drug for pulmonary fibrosis, enters global clinical studies phase 1 - The world’s first-in-class PRS inhibitor commences global clinical studies in coming September. - Selected for the U.S. FDA Orphan Drug Designation with priority review and exclusive rights. DWN12088, the new drug for pulmonary fibrosis being developed by Daewoong Pharmaceutical (CEO Sengho Jeon), is entering the global clinical studies. It has been announced that DWN12088, the new drug for idiopathic pulmonary fibrosis being developed by Daewoong Pharmaceutical, has been approved for the local clinical studies phase 1 by the Therapeutic Goods Administration (TGA) of Australia on the 21st.  Therefore, the clinical studies will commence in coming September. Idiopathic pulmonary fibrosis is one of the interstitial pulmonary diseases where the lungs slowly harden to lose function.  It is a rare disease that is difficult to cure with less than 40% survival rate in five years after diagnosis. ‘DWN12088’ is an oral drug for fibrosis that selective decreases the activation of PRS protein to inhibit excess generation of collagen that causes pulmonary fibrosis.  It has proven improved efficacies and safety compared to the existing drugs in the animal models with pulmonary fibrosis through pre-clinical studies.  The phase 1 clinical test will be done on healthy people to secure safety and tolerability. In prior to the approval for global clinical studies, ‘DWN12088’ was selected for Korea Drug Development Fund’s sponsorship for new drug development due to the needs to develop drugs for fibrosis diseases and for the U.S. FDA’s Orpha Drug Designation. “‘DWN12088,’ Daewoong Pharmaceutical’s world’s first PRS inhibitor, has been selected for the U.S. FDA’s Orpha Drug Designation and will commence global clinical studies,” said Director Joon Seok Park of Daewoong Pharmaceutical’s New Drug Center.  “We will expand studies in various fibrosis diseases that affect the skin, kidney, liver, and heart and strengthen our R&D department on rare diseases.” Daewoong Pharmaceutical is planning to focus capacities on the R&D of various first-in-class drug lineups, including DWP14012 for gastroesophageal reflux disease, DWP16001 for SGLT-2 inhibition, and HL036 for dry eye syndrome and prepare for the 'Next NABOTA' to grow into a global pharmaceutical company. #   #   #

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