- We confirmed the safety of 'DWN12088' and secured grounds for establishing treatment dosage
- Confirming the potential as a treatment for IPF and planning to apply for Ph.2 within 2021
- 2nd ODD granted as treatment for systemic sclerosis from the US FDA
SEOUL, South Korea, May 24, 2021 /PRNewswire/ -- Daewoong Pharmaceutical of South Korea has announced the promising clinical results of DWN12088, which is being developed as a first-in-class Prolyl-tRNA Synthetase (PRS) inhibitor for idiopathic pulmonary fibrosis (IPF) .
Daewoong Pharmaceutical (CEO Sengho Jeon) presented the results of Phase I clinical trial of DWN12088 at American Thoracic Society (ATS2021) which was held online from May 14 to 19 (local time).
In this study, 72 healthy adults of various ethnical backgrounds were tested for single-ascending dose test (SAD) and multiple- ascending dose test (MAD) in Australia to evaluate safety, tolerability and pharmacokinetic properties of DWN12088.
The clinical results confirmed the safety and tolerability of DWN12088, and the blood concentration after drug administration to provide a basis for further clinical development. In particular, Daewoong has confirmed DWN12088-specific pharmacodynamic markers, which provides promising possibility as a treatment for idiopathic pulmonary fibrosis.
Daewoong is expected to file Ph. 2 IND to include multi-national studies, including US and Korea, by end of this year.
DWN12088 has also been recently granted with Orphan Drug Designation (ODD) for systemic sclerosis by the US FDA. This is the second time that DWN12088 has been granted with ODD status, followed by ODD for IPF in 2019.
"We have established the basis for Ph. 2 trials by confirming safety, tolerability and pharmacokinetic profile of DWN12088," said Mr. Jeon, CEO Sengho Jeon at Daewoong, "In addition to lung fibrosis, we will expand our research on fibrosis in other organs such as heart, liver, kidney and skin."
Fibrosis is characterized by an abnormal increase of collagen in the body, and IPF is a type of lung disease that results in hardening/stiffness (fibrosis) in the lung and leads to loss of lung function with an unknown cause. It is a progressive, fatal rare disease with a 5-year survival rate of less than 40%.
Daewoong Pharmaceutical is developing 'DWN12088' as a first-in-class PRS inhibitor for IPF treatment. DWN12088 inhibits PRS activity to reduce collagen production, which is a pathological hallmark of fibrosis. DWN12088 was supported by Korea Drug Development Fund.
About Daewoong Pharmaceutical. Co., Ltd.
Daewoong Pharmaceutical. is a global healthcare corporation founded in 1945 with the belief to 'create good medicine to protect the health of the people and create a healthy society.' Major business areas are hospital prescription drug (ETC) sector, over-the-counter medicine (OTC) sector, exportation of finished products and raw material medicine sector, and consignment production sector. Daewoong continues to invest more than 10% of its sales in R&D every year, focusing on developing gastrointestinal (GI), endocrine, orphan and stemcell based therapeutics.
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