New Delhi: Citing that the rationale for conduct of the proposed trial of COPD (Chronic obstructive pulmonary disease) drug Tozorakimab is not adequate, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has directed the drug maker AstraZeneca to submit proof of concept data for the proposed indication and published data on prevalence of proposed disease i.e. viral lungs infections/viral Pneumonia vis a vis number of patients hospitalized for viral lung infection requiring supplement oxygen or requiring ventilation in India.
This came after the drug major AstraZeneca presented their proposal for Phase III clinical trial protocol number D9185C00001 version 1.0 15-Sept2022(TILIA) and Local CSP Addendum IND-1 version 1.0 dated 14-10-2022 before the committee.
Tozorakimab is an IL-33 (interleukin-33) monoclonal antibody being developed by AstraZeneca for the treatment of chronic obstructive pulmonary disease, diabetic nephropathies, COVID-2019 infections and atopic dermatitis.
Tozorakimab inhibits the binding of IL-33 to the ST2 receptor and helps to control inflammation by blocking IL-33/ ST2 signaling. IL-33/ ST2 signaling plays immune regulatory functions in many diseases.
At the recent SEC meeting for pulmonary held on 7th December 2022, the expert panel reviewed the Phase III clinical protocol of the COPD drug Tozorakimab (protocol number D9185C00001 version 1.0 15-Sept2022(TILIA)) and Local CSP Addendum IND-1 version 1.0 dated 14-10-2022.
After detailed deliberation, the committee recommended that the rationale for conduct of the proposed trial is not adequate and the applicant should submit the following for further consideration by the committee.
1. Proof of concept data for the proposed indication.
2. Published data on prevalence of proposed disease i.e. viral lungs infections/viral Pneumonia vis a vis number of patients hospitalized for viral lung infection requiring supplement oxygen or requiring ventilation in India.