CDSCO Panel Approves AstraZeneca's Phase III CT proposal For COPD Drug Tozorakimab
New Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase III clinical trial of the Chronic Obstructive Pulmonary Disease (COPD) drug Tozorakimab.
However, the approval is based upon the following condition: "Data and Safety Monitoring Board (DSMB) shall actively and frequently monitor each subject enrolled in the study for adverse events, especially in non-viral groups."
This came after the firm presented their proposal of Phase –III clinical trials vide protocol No: D9185C00001, version 1.0, dated 15 Sep 2022, and local addendum IND-1 version: 1.01 dated 14 Oct 2022.
Tozorakimab 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 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.
As previously reported by the Medical Dialogues Team, AstraZeneca received approval from the Subject Expert Committee (SEC) functioning under the Central Drug Standard Control Organisation (CDSCO) to carry out the Phase II clinical trial of the Chronic Obstructive Pulmonary Disease (COPD) drug Tozorakimab.
At the recent SEC meeting for Pulmonary held on 8th August 2023, the expert panel reviewed the proposal of Phase-III clinical trials vide protocol No: D9185C00001, version 1.0, dated 15 Sep 2022, and local addendum IND-1 version: 1.01 dated 14 Oct 2022, presented by AstraZeneca.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial subject to the condition that DSMB shall actively and frequently monitor each subject enrolled in the study for adverse events, especially in non-viral groups.
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