- U.S. Food and Drug Administration (FDA) approved the IND for the phase 2 clinical trial for patients with idiopathic pulmonary fibrosis

- Daewoong Pharmaceutical to start a multinational phase 2 clinical trial for DWN12088 in September

SEOUL, South Korea, June 24, 2022 /PRNewswire/ -- Daewoong announced that the U.S. Food and Drug Administration (FDA) had approved the IND for the phase 2 clinical trial of DWN12088, a PRS (Prolyl-tRNA Synthetase) inhibitor for patients with idiopathic pulmonary fibrosis. Daewoong plans to start the clinical trial this September, and with this enters its global phase 2 clinical trial for a new drug for idiopathic pulmonary fibrosis.

This phase 2 clinical trial will be conducted as a multinational clinical study simultaneously in the United States and South Korea to evaluate the safety and efficacy of DWN12088. The improvement in the deteriorated forced vital capacity (FVC) will be evaluated after oral administration of the study drug or placebo for 24 weeks in 102 patients with idiopathic pulmonary fibrosis (IPF). The foundation for a phase 2 clinical trial of DWN12088 has been laid by confirming the safety and pharmacokinetic properties of 162 healthy subjects in multiple phase 1 clinical trials conducted in Australia and South Korea.

Idiopathic pulmonary fibrosis is a lung disease in which the lungs gradually harden and lose their function due to excessively produced fibrous tissue. It is a rare disease with a 5-year survival rate of less than 40% after diagnosis, as it is challenging to treat. Current commercialized drugs for idiopathic pulmonary fibrosis from several multinational pharmaceutical companies currently do not completely stop the disease progression itself, and there are still have a high unmet medical needs as the treatment abandonment rate is high due to the side effects.

DWN12088 is the world's first PRS inhibitory anti-fibrotic agent developed by Daewoong. PRS is an enzyme that plays an important role in collagen synthesis, and DWN12088 has a mechanism to suppress enzymatic activity of PRS to reduce excessive production of collagen.

Daewoong has demonstrated excellent anti-fibrotic and pulmonary function improvement effects by co-administering DWN12088 and existing drugs in an animal model presented at the annual academic conference of the American Thoracic Society (ATS2021) in May of last year. It has been designated as an orphan drug for idiopathic pulmonary fibrosis by the U.S. FDA in 2019.

If Daewoong proves the anti-fibrotic effect with the PRS inhibitor in humans (human proof of concept) through this clinical trial, DWN12088 is expected to leap into a new global blockbuster drug that surpasses existing drugs. In addition to pulmonary fibrosis, Daewoong also plans to expand the indications of DWN12088 for skin, kidney, liver and other rare fibrotic diseases.

"The existing treatments of Idiopathic pulmonary fibrosis still have high unmet medical needs," said Sengho Jeon, CEO of Daewoong Pharmaceutical. "We will strive to carry out our corporate mission to fulfill the unmet medical needs and lead the improvement of quality of human life by providing innovative new drugs to the patients with idiopathic pulmonary fibrosis through DWN12088."

Meanwhile, according to ResearchAndMarkets, a global market research firm, the annual growth rate of idiopathic pulmonary fibrosis treatment is showing 7% growth annually, and they predicted the market will reach $6.1 billion by 2030.