CDSCO Panel Approves AstraZeneca's Protocol Amendment Proposal For COPD Drug Study

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal presented by the drug major AstraZeneca for the drug MEDI3506 (Tozorakimab), an anti-IL-33 antibody.

This came after AstraZeneca presented protocol amendment No. 2.0 (version 3.0) dated 23 Jun 2023, protocol No. D9180C00003. This is a phase III, multicentre, randomized, double-blind, chronic-dosing, parallel-group, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of tozorakimab in participants with symptomatic chronic obstructive pulmonary disease (COPD) with a history of COPD exacerbations.

The study aims to assess the efficacy, safety, and tolerability of tozorakimab in patients with symptomatic chronic obstructive pulmonary disease (COPD) with a history of exacerbations.

Tozorakimab (MEDI3506) is an anti-IL-33 antibody that inhibits IL-33 signaling via ST2 and RAGE/EGFR to reduce inflammation and epithelial dysfunction. 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.

At the recent SEC meeting for Pulmonary meeting held on 5th March 2024, the expert panel reviewed the proposal for protocol amendment No. 2.0 (version 3.0) dated 23 Jun 2023, protocol No. D9180C00003.

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

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