New Delhi: Major pharmaceutical company AstraZeneca has received the green signal from the Committee of Subject Matter Experts (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the phase II clinical trial of the drug Tozorakimab for the disease chronic obstructive pulmonary disease (COPD).
This came after the company presented a study in acute viral infection respiratory failure (ARDS) excluding COVID-19 and offered to conduct a phase II study via protocol no: D9185C00001 version 1.0 , 15-Sep-2022 and Local CSP Addendum IND-1: Version 1.0, dated October 14, 2022 before the Committee.
Tozorakimab (MEDI-3506) is being developed for the treatment of diabetic nephropathy, coronavirus disease (COVID-19), chronic bronchitis, asthma, acute respiratory failure and chronic obstructive pulmonary disease (COPD). The drug candidate is administered subcutaneously or intravenously in the form of a solution. It is a monoclonal antibody that works by targeting interleukin-33 (IL-33). The drug candidate is a new molecular entity. It was also being developed 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 therapeutic areas such as respiratory, cardiovascular, renal and metabolic diseases, cancer, autoimmune, infectious and neurological diseases.
At the recent SEC meeting for Pulmonary held on May 10, 2023, the panel reviewed the proposal submitted by AstraZeneca to conduct a Phase II study under protocol no: D9185C00001 version 1.0, 15-Sep -2022 and Local CSP Addendum IND-1: Version 1.0, October 14, 2022 before the commission.
After detailed deliberation, the committee recommended granting authorization to conduct the phase II clinical trial as presented by the company.
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