At a Glance
- FDA cleared IND for AK3280, enabling U.S. Phase 2 PoC trial in IPF patients.
- Multi-center, randomized trial evaluates efficacy, safety, and PK of oral AK3280 vs. placebo/active controls.
- China Phase 2 showed dose-dependent FVC gains at Week 24 with favorable GI tolerability.
- Addresses IPF unmet needs beyond pirfenidone, nintedanib, nerandomilast limitations
Written By: Pharmacally Medical News Desk
Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for AK3280, a novel anti-fibrotic therapy being developed for idiopathic pulmonary fibrosis (IPF). The clearance enables ArkBio to initiate a Phase 2 proof-of-concept (PoC) clinical trial in the United States.
The Phase 2 study will be conducted as a multi-center, randomized, partially double-blind, placebo- and active-controlled trial designed to evaluate the efficacy, safety, and pharmacokinetics of oral AK3280 in patients with IPF. The authorization represents an important step in the global clinical development of the investigational therapy.
Idiopathic pulmonary fibrosis is a progressive, irreversible interstitial lung disease characterized by fibrotic remodeling of lung tissue that can lead to respiratory failure.
ArkBio noted that currently approved therapies, including pirfenidone, nintedanib, and nerandomilast, are intended to slow disease progression, although treatment responses may vary among patients.
The company also stated that these therapies are commonly associated with adverse events, particularly gastrointestinal effects such as diarrhea and nausea, which may affect tolerability and long-term adherence in some individuals.
According to ArkBio, these limitations highlight the ongoing need for additional treatment options in IPF.
AK3280 is described as an optimized small-molecule, broad-spectrum anti-fibrotic agent. In a Phase 2 PoC study conducted in China, AK3280 demonstrated encouraging clinical activity, including a statistically significant, dose-dependent absolute increase from baseline in forced vital capacity (FVC) at Week 24.
Improvements were also observed across additional lung function measures. Notably, the therapy exhibited a favourable safety and tolerability profile, with no apparent increase in the gastrointestinal adverse effects commonly associated with existing IPF treatments.
With IND clearance, ArkBio will generate data from this international Phase 2 PoC study to support regulatory submissions and commercialization in the U.S. and global markets.
Reference
Novel Anti-Fibrotic Drug AK3280 Cleared by FDA to Initiate Phase 2 Proof-of-Concept Clinical Trial in IPF, 12 February 2026, https://arkbiosciences.com/80/115