Ark Biopharmaceutical Receives the FDA IND Clearance to Initiate P-II Trial of AK3280 in Idiopathic Pulmonary Fibrosis

Shots:

• The US FDA has granted IND Clearance to initiate P-II PoC trial of AK3280 in the US for the treatment of idiopathic pulmonary fibrosis (IPF)
• The P-II PoC trial will evaluate AK3280 (PO) vs PBO & an active comparator in IPF pts, aiming to generate key clinical data to support future regulatory filings & potential commercialization in the US & other major markets
• AK3280 showed favorable P-II PoC results in China, demonstrating a statistically significant, dose-dependent increase in FVC at Wk. 24, with improvements across additional lung function measures indicating meaningful clinical benefit

Ref: PRnewswire |  Image: ArkBio  | Press Release

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