23:18 ETNovel Anti-Fibrotic Drug AK3280 Cleared by FDA to Initiate Phase 2 Proof-of-Concept Clinical Trial in IPF

, /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today 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 for the treatment of idiopathic pulmonary fibrosis (IPF). This clearance enables ArkBio to initiate a Phase 2 proof-of-concept (PoC) clinical trial of AK3280 in the United States. The Phase 2 study is 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. Authorization to proceed with a U.S. Phase 2 study represents a significant milestone in the global clinical development of AK3280. IPF is a progressive, irreversible, and ultimately fatal interstitial lung disease characterized by fibrotic remodeling of lung tissue that leads to respiratory failure. The median survival following diagnosis is approximately 2–5 years. Currently approved therapies, including pirfenidone, nintedanib, and nerandomilast, can slow disease progression; however, their clinical benefit remains limited and they are frequently associated with gastrointestinal adverse events such as diarrhea and nausea. These tolerability challenges contribute to poor long-term adherence in a substantial proportion of patients. There remains a significant unmet need for therapies that provide improved efficacy with enhanced safety and tolerability profiles. AK3280 is an optimized, small-molecule, broad-spectrum anti-fibrotic agent. In a Phase 2 proof-of-concept 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 parameters, suggesting meaningful clinical benefit. Importantly, AK3280 exhibited a favorable safety and tolerability profile, with no apparent increase in the gastrointestinal adverse effects commonly associated with currently available IPF therapies. FDA clearance of the IND marks a pivotal step in the global development of AK3280. The upcoming international Phase 2 PoC trial is expected to generate critical clinical data to support future regulatory submissions and potential commercialization in the United States and other major markets. ArkBio remains committed to advancing AK3280 globally and to delivering more effective and better-tolerated treatment options for patients living with IPF. About ArkBio ArkBio is a commercial-stage biotechnology company focused on the discovery and development of innovative therapeutics for respiratory and pediatric diseases. Founded in 2014, the company has established proprietary technology platforms and a differentiated R&D pipeline through internal innovation and strategic collaborations. Key pipeline assets include: Ziresovir (AK0529), the first direct-acting antiviral for RSV with positive pivotal Phase 3 results; AK3280, a potentially best-in-class anti-fibrotic agent with positive Phase 2 results in idiopathic pulmonary fibrosis; AK0901, approved in China for the treatment of ADHD and currently commercialized. ArkBio has established strategic partnerships with multinational pharmaceutical companies and leading academic institutions, including Roche, Genentech, The Scripps Research Institute, and the Institute of Microbiology of the Chinese Academy of Sciences, as well as domestic and international biotech companies and venture capital partners. For more information, please visit: www.arkbiosciences.comInvestor Inquiries: [email protected] SOURCE Arkbio