CDSCO Panel Approves AstraZeneca's Protocol Amendment Proposal for Tozorakimab Study

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved AstraZeneca's proposal for protocol amendment of the clinical trial titled "Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease with a History of Exacerbation."

This came after the firm presented protocol no. D9180C00012, amendment version 2.0 dated 12 Jun 2024.

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the 12 months prior to enrolment.

Tozorakimab (MEDI3506), developed by AstraZeneca, was investigated in multiple clinical trials to evaluate its safety, tolerability, efficacy, and pharmacokinetics across various conditions.

Tozorakimab is a human monoclonal antibody that neutralizes interleukin (IL)-33. IL-33 is a broad-acting epithelial "alarmin" cytokine upregulated in the lung tissue of patients with chronic obstructive pulmonary disease (COPD).

Tozorakimab (MEDI3506) is a high-affinity anti-IL-33 monoclonal antibody. It inhibits IL-33-induced signaling to produce an anti-inflammatory effect. Tozorakimab blocks the actions of both reduced IL-33 (IL-33red) and oxidized IL-33 (IL-33ox) metabolites through their respective downstream pathways (ST2 for IL-33red, RAGE/EGFR complex for IL-33ox)

At the recent SEC meeting for pulmonary held on 3rd October 2024, the expert panel reviewed protocol no. D9180C00012, amendment version 2.0 dated 12 Jun 2024.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

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