Include more Govt sites: CDSCO panel to Sanofi on clinical trial of pulmonary disease drug
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has granted permission to Sanofi to conduct the Clinical Trial of SAR440340/REGN3500.
However, permission has been granted based on the condition that the firm should include more government sites across India.
To reach the medical need of providing treatment in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD); the firm presented the proposed global Phase III clinical trial before the committee at the 50th SEC meeting ((Pulmonary) held on 26.02.2021& 01.03.2021 at CDSCO HQ New Delhi.
Further, it was stated that in terms of assessment of risk vs. benefit to the patients, the safety profile of the study drugs from preclinical toxicology studies including Single-Dose Toxicity, repeat dose toxicity, Phase I and III clinical study justify the conduct of the trial.
The purpose of the study is to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (antiIL-33mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
COPD is a condition of obstructive pulmonary disease (COPD) characterized by chronic, partially reversible inadequate airflow (airflow limitation) and the inability to fully exhale (air trapping). The airflow restriction is typically progressive and associated with an irregular inflammatory response of the lungs to noxious particles or gases, which is most generally triggered by tobacco smoking.
SAR440340 is a human IgG4P monoclonal antibody (mAb) against IL-33. IL-33 is an epithelial cytokine that initiates and amplifies innate and adaptive type 2 and 1 inflammatory pathways in response to epithelial insults due to exposure to allergens, viruses, cigarette smoke and pollutants. By targeting both type-2 and type-1 inflammation, SAR440340 may be efficacious in a broader asthma population.
After detailed deliberation and discussion, the committee recommended for the grant of permission to conduct the Clinical Trial subject to the condition that the firm should include more government sites across India.