South Korea’s Daewoong Pharm said on Thursday that Australia`s Therapeutic Goods Administration has given the green light to its phase 1 clinical trial of DWN12088, an idiopathic pulmonary fibrosis (IPF) drug, which will begin next month.

IPF is an interstitial lung disease characterized by the lung’s gradual hardening and loss of its function. The disease is difficult to treat with a five-year survival rate of less than 40 percent.

DWN12088 is the first-in-class oral IPF therapy that selectively inhibits Prolyl-tRNA Synthetase (PRS) protein activity and excessive production of collagen, the main cause of pulmonary fibrosis. Data from preclinical studies confirmed the efficacy and safety of the treatment compared to existing drugs.

DWN12088 was named one of the national novel drug projects eligible for state research funds and granted an orphan drug designation (ODD) from the U.S. Food and Drug Administration ahead of the trial approval in Australia.

The FDA ODD certification facilitates the development and approval of drugs for rare or refractory diseases by exempting the manufacturer from license review fees and enabling an option for priority review as well as seven-year monopoly after marketing authorization.

Daewoong Pharm has focused its R&D resources with a robust portfolio of investigational therapies such as gastroesophageal reflux drug DWP14012, SGLT-2 inhibitor DWP16001 and dry eye drug HL036.

By Kim Byung-ho and Minu Kim

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