Shanghai Ark Biopharmaceutical (ArkBio) has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for AK3280, an investigational anti-fibrotic therapy for Idiopathic Pulmonary Fibrosis (IPF). The clearance allows the company to initiate a Phase II proof-of-concept (PoC) clinical trial in the United States.

The planned Phase II study will be a multi-centre, randomised, partially double-blind, placebo- and active-controlled trial designed to assess the efficacy, safety and pharmacokinetics of oral AK3280 in patients diagnosed with IPF. The authorisation to begin the US trial represents a step in the global clinical development programme for the candidate.

Idiopathic pulmonary fibrosis is a chronic, progressive interstitial lung disease marked by scarring of lung tissue, leading to declining lung function and eventual respiratory failure. Median survival following diagnosis is estimated at two to five years. Although currently approved treatments such as pirfenidone, nintedanib and nerandomilast can slow disease progression, their overall clinical benefit is limited and they are often associated with gastrointestinal side effects including diarrhea and nausea. These adverse events can affect long-term treatment adherence, highlighting the continued need for therapies with improved efficacy and tolerability.

AK3280 is a small-molecule, broad-spectrum anti-fibrotic agent. In a previously conducted Phase II proof-of-concept study in China, the drug demonstrated a statistically significant, dose-dependent increase in Forced Vital Capacity (FVC) from baseline at Week 24. Additional improvements were observed in other lung function parameters. The therapy was generally well tolerated, with no apparent increase in gastrointestinal adverse events commonly seen with existing IPF treatments.

With FDA IND clearance now secured, the company plans to advance AK3280 into international Phase II development. Data generated from the US trial are expected to support future regulatory discussions and potential filings in the United States and other markets.