AstraZeneca Gets CDSCO Panel Nod To study COPD Drug Tozorakimab

This came after the firm presented a study for acute viral infection respiratory failure (ARDS) except for COVID-19 and proposed conducting Phase II study vide protocol no: D9185C00001 version 1.0, 15-sep-2022 and local CSP Addendum IND-1: version 1.0, dated 14-Oct-2022 before the committee.

Tozorakimab (MEDI-3506) is under development for the treatment of diabetic kidney disease, Coronavirus disease (COVID-19), chronic bronchitis, asthma, acute respiratory failure, and chronic obstructive pulmonary disease (COPD). The drug candidate is administered through a subcutaneous or intravenous route in the form of a solution. It is a monoclonal antibody that acts by targeting the interleukin-33 (IL-33). The drug candidate is a new molecular entity. It was also under development for the treatment of atopic dermatitis

Tozorakimab is a novel therapeutic agent with a dual mechanism of action that blocks IL-33red and IL-33ox signaling, offering the potential to reduce inflammation and epithelial dysfunction in human disease. It develops products related to therapy areas such as respiratory, cardiovascular, renal, and metabolic diseases, cancer, autoimmune, infection, and neurological diseases.

At the recent SEC meeting for Pulmonary held on 10th May 2023, the expert panel reviewed the proposal presented by AstraZeneca for conducting Phase II study vide protocol no: D9185C00001 version 1.0, 15-sep-2022 and local CSP Addendum IND-1: version 1.0, dated 14-Oct-2022 before the committee.

After detailed deliberation, the committee recommended the grant of permission for the conduct of Phase II clinical trial as presented by the firm.

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