Shanghai,, May 7, 2025 / Prnewswire / – Shanghai Ark Biopharmaceutical Co., Ltd. (“Arkbio”) announced today the positive results of phase II study of phase II for its new anti-fibrotic drug AK3280 in the treatment of idiopathic pulmonary fibrosis (IPF). The study, led by the professor Huaping Dai of the Department of Pulmonary Medicine and Intensive Care at the China-Japan Friendship hospital, Beijingwas carried out on 31 clinical sites in China.
Global clinical challenge: Non -resolved IPF processing needs
Idiopathic pulmonary fibrosis (IPF) is a progressive, irreversible and fatal interstitial pulmonary disease characterized by fibrotic remodeling of pulmonary tissue, ultimately leading to respiratory failure, with a median survival period of only 2 to 5 years after the diagnosis. Current therapies, including pirfenidone and nintedanib, have been available for years, however, with limited efficiency, significant undesirable effects and poor long -term tolerability, highlighting the urgent need for new and more effective therapies.
Study of proof of phase 2 concept of AK3280, a largely active anifibrotic drug
AK3280 is a largely active anifibrotic drug of the new generation which is optimized for pharmacological and pharmacokinetic properties based on current IPF drugs. Preclinical data indicate that it has improved anti-fibrotic activity and improved pharmacokinetic properties, without the problems of gastrointestinal tous and other toxicities associated with current therapies. Previous studies of phase I have demonstrated its favorable security, its tolerability and its human pharmacokinetic profile.
The study of randomized randomized concept, double -blind and controlled by placebo, has evaluated the safety, tolerability and clinical efficiency of the AK3280 China IPF patients. Participants were randomized to receive AK3280 (100/200/300/400 mg of offer) or a placebo for 24 weeks. The clinical efficiency evaluation criteria included the forced vital capacity of lungs (FVC and% PFVC), the dissemination capacity of the lung for carbon monoxide (DLCO), the 6 -minute walking test (6MWT) and the patient reported the scores of the respiratory questionnaire of St. George (SGRQ). The high -dose groups have shown an improvement in the FVC compared to the basic line, in particular the 400 mg group which increased the absolute FVC of 209.4 ml and an improvement of adjusted PFVC of 6.4% compared to the base line, which is statistically significant compared to placebo (p = 0.002 and 0.004, respectively). Other pulmonary and respiratory functions have also improved. The drug had a good safety and tolerability profile without the problems of gastrointestinal intolerability associated with current IPF therapy.
Implications for future IPF therapies
This study with a rigorous, randomized and double blind multicentric study conception for 24 weeks, followed by another 24 -week open study, represents the first study of proof of phase 2 concept of AK3280 in the populations of fibrotic patients. These results not only demonstrate the potential of AK3280 to improve both lung function and respiratory results, but also highlight its unique safety profile which could support long -term use, by positioning it as a future potential stand therapy for IPF treatment.
Doctor Huaping DaiThe main investigator of the phase 2 study and professor at the China-Japan Friendship hospital, said: “In the IPF therapeutic landscape, the development of safer and more effective anti-fibrotic agents remains urgent. An absolute absolute increase in the FVC over 24 weeks.
About AK3280
AK3280 is an anti-fibrotic molecule with broad-spectrum of new potential generation optimized from the drug marketed. It modulates several ways and biomarkers closely associated with the fibrotic process, in particular the expression of genes and proteins linked to fibrosis induced by the transformation of the growth factor-Bêta (TGF-β) and lysophosphatidic (LPA) acid. AK3280 works by reducing cell proliferation of fibroblasts and inhibiting the synthesis and accumulation of extracellular matrix. Compared to current therapies, AK3280 offers safety and tolerability advantages, with potentially improved clinical efficiency. The clinical study of randomized phase II randomized confirmation confirmation, in double blind and controlled by placebo has been completed, and preparations are underway to initiate the Phase III clinical study.
About Arkbio
Arkbio is a global biotechnology company focused on the development of innovative therapies for respiratory, infectious and pediatric diseases. Founded in 2014, it built basic technological platforms and a differentiated R&D pipeline thanks to internal R&D efforts and external collaboration. Key drug assets include ZiresovirThe first RSV antiviral with direct action with positive results of Pivot III phase, and AK0901A therapeutic drug of pediatric ADHD approved by the FDA. Arkbio has established strategic partnerships with several multinational pharmaceutical companies and university institutes, notably Roche, Genentech, the Scripps research instituteThe Institute of Microbiology of the Chinese Academy of Sciences, national and international biotechnology societies, as well as venture capital institutions.
For more business information, please visit our website: www.arkbiosciences.com
Investor requests: Ir@arkbiosciences.com
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