Dazukibart (previously known as PF-06823859) is a humanized monoclonal antibody developed by Pfizer for the treatment of autoimmune diseases, particularly dermatomyositis and systemic lupus erythematosus.[1] It is classified as a potent, selective, humanized IgG1 neutralizing monoclonal antibody that specifically targets interferon beta (IFN-β).[2]
Dazukibart functions by neutralizing interferon beta-1 (IFNB1), a type I interferon that plays a critical role in autoimmune inflammation.[3] The drug targets the dysregulated type I interferon pathway that is characteristic of several autoimmune conditions, particularly dermatomyositis, where IFN-β rather than IFN-α has been identified as the predominant elevated interferon.[4]
Administration and dosing
Dazukibart is administered through intravenous infusion, though subcutaneous formulations are also being investigated.[3] The drug is currently being evaluated in ongoing clinical trials to determine optimal dosing regimens for different indications.
Clinical development
Phase I studies
Initial safety and pharmacokinetic studies of dazukibart (then known as PF-06823859) were published in 2020, demonstrating an acceptable safety and tolerability profile in healthy volunteers. These studies supported its continued development for disorders associated with increased interferon β levels.[5]
Phase II studies
A landmark phase 2 clinical trial published in The Lancet in January 2025 demonstrated significant efficacy of dazukibart in treating adults with moderate-to-severe dermatomyositis. The multicentre, double-blind, randomized, placebo-controlled study was conducted across 25 sites in Europe and the USA.[1][4] The study showed that both 150 mg and 600 mg IV doses every 4 weeks met the primary endpoint of significantly decreasing CDASI-A scores at 12 weeks compared with placebo, with dazukibart resulting in a pronounced reduction in disease activity and being generally well tolerated.[1][6]
Phase III studies
As of 2025, dazukibart has entered Phase 3 clinical trials for the treatment of myositis, indicating advancement toward potential regulatory approval.[7][8]
Therapeutic indications
Dermatomyositis
The primary indication for dazukibart is dermatomyositis, a chronic autoimmune disease characterized by distinctive cutaneous eruptions, muscle weakness, and systemic manifestations including interstitial lung disease. Clinical studies have shown rapid onset of response in adult patients with moderate-to-severe refractory dermatomyositis.[9]
Other indications
Dazukibart is also being investigated for the treatment of systemic lupus erythematosus and polymyositis, conditions that also involve dysregulated type I interferon signaling.[10]
Regulatory status
Dazukibart has received orphan drug designation from the European Medicines Agency (EMA) for the treatment of dermatomyositis (designation EU/3/20/2392), recognizing the significant medical need for effective treatments for this rare autoimmune condition.[11]
↑ Neelakantan S, Oemar B, Johnson K, Rath N, Salganik M, Berman G, etal. (1 March 2021). "Safety, Tolerability, and Pharmacokinetics of PF-06823859, an Anti-Interferon β Monoclonal Antibody: A Randomized, Phase I, Single- and Multiple-Ascending-Dose Study". Clinical Pharmacology in Drug Development. 10 (3): 307–316. doi:10.1002/cpdd.887. ISSN2160-7648. PMID33352008.
This page is based on this Wikipedia article Text is available under the CC BY-SA 4.0 license; additional terms may apply. Images, videos and audio are available under their respective licenses.
