Pfizer's Anti-Interferon Beta Monoclonal Antibody PF-06823859 Receives IND Approval in China for Dermatomyositis

By | Pharma Insights

The latest public notice from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) indicates that Pfizer's Class 1 new drug, PF-06823859 injection, has been granted tacit approval for a clinical trial, intended for the treatment of dermatomyositis. Public records show that PF-06823859 is an investigational anti-interferon-beta monoclonal antibody that has globally advanced to Phase II clinical trials.

Source: CDE Official Website

PF-06823859 is a humanized interferon-β antibody developed by Pfizer that blocks interferon beta-1 (IFNB1). It is being developed for the treatment of dermatomyositis and lupus. Recently in China, PF-06823859 has been approved to initiate clinical trials for dermatomyositis. Dermatomyositis is an autoimmune disease that causes cutaneous changes and muscle weakness. Symptoms include a red rash around the eyelids, red nodules around the joints, and muscle weakness in the arms and legs. Over time, muscle weakness may progressively worsen, potentially leading to joint stiffness and muscle atrophy.

According to the information posted on the ClinicalTrials.gov website, Pfizer has currently registered multiple clinical trials for PF-06823859, including two Phase I randomized, double-blind, open-label, placebo-controlled studies in healthy subjects, and a Phase II randomized, double-blind, placebo-controlled study in adult patients with dermatomyositis.

In December 2020, Pfizer announced the results of a Phase 1 clinical trial of PF-06823859. This was a randomized, double-blind, placebo-controlled, dose-escalation first-in-human study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PF-06823859. Healthy subjects were randomized to different cohorts to receive single and multiple intravenous and subcutaneous doses of PF-06823859.

The results showed that in the single ascending dose cohort, all treatment-emergent adverse events (AEs) were mild; in the multiple ascending dose cohort, four adverse events of moderate severity were identified. No dose-limiting AEs, serious AEs, treatment-related discontinuations, dose reductions, or deaths occurred. Additionally, the study demonstrated that PF-06823859 exposure increased proportionally with dose, with a half-life ranging from 23 to 35 days, an estimated subcutaneous bioavailability of 43% to 44%, a low incidence of immunogenicity, and no immunogenicity-related clinical responses were observed.

The study indicates: PF-06823859 demonstrated an acceptable safety, tolerability, and pharmacokinetic profile, supporting its clinical development for the treatment of diseases associated with elevated interferon-β levels (such as dermatomyositis or systemic lupus erythematosus).

References:

[1] Center for Drug Evaluation, National Medical Products Administration. Retrieved Oct 14, 2021, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2]Clinicaltrials.gov. Retrieved Oct 14, 2021, from https://clinicaltrials.gov/ct2/results?cond=&term=PF-06823859&cntry=&state=&city=&dist=

[3]Neelakantan S, Oemar B, et al. (2020). Safety, Tolerability, and Pharmacokinetics of PF-06823859, an Anti-Interferon β Monoclonal Antibody: A Randomized, Phase I, Single- and Multiple-Ascending-Dose Study. Clin Pharmacol Drug Dev. doi: 10.1002/cpdd.887.

▽Follow 【WuXi AppTecGermany】WeChat Official Account