Pfizer Gets CDSCO Panel Nod to Study PF-06823859
New Delhi:The drug major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the trial for the drug PF-06823859
This came after the firm presented phase 3 clinical study protocol no. C0251010 version original, dated 08 April 2024.
Dazukibart (PF-06823859) is under development for the treatment of moderate to severe dermatomyositis, cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus (SCLE), chronic cutaneous lupus erythematosus (CCLE), systemic lupus erythematosus.
PF-06823859 is a potent, selective, humanised immunoglobulin 1-neutralising monoclonal antibody (mAb) directed against human IFNβ. Dazukibart is a monoclonal antibody, a type of biologic drug specifically designed to target and inhibit certain proteins associated with autoimmune diseases.
Dazukibart targets the IL-23 cytokine, a protein that is heavily involved in the body's immune response. IL-23 plays a pivotal role in the development and maintenance of chronic inflammation, a hallmark of many autoimmune conditions.
At the recent SEC meeting for Analgesic and Rheumatology held on October 3, 2024, the expert panel reviewed phase 3 clinical study protocol no. C0251010 version original dated 08 April 2024.
After detailed deliberation, the committee recommended granting permission to conduct the trial as presented by the firm.
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