Sanofi received approval from the Subject Expert Committee (SEC), operating under the Central Drugs Standard Control Organization (CDSCO), for the clinical trial numbered CT/24/000005. This approval was granted for the investigational drug REGN3500 (Itepekimab), a solution containing 300 mg (150 mg/mL).
Chronic respiratory disorders affect an estimated 545 million individuals worldwide, resulting in significant morbidity and mortality. The most common conditions are chronic obstructive pulmonary disease (COPD) and asthma, with latest projections of 3.9% and 3.6%, respectively.
Itepekimab, formerly known as REGN3500 and SAR440340, is a fully human monoclonal antibody produced using VelocImmune technology. Itepekimab is under development for the treatment of chronic obstructive pulmonary disease. It is administered intravenously and subcutaneously. It acts by targeting the interleukin-33 (IL-33). Airway epithelial and endothelial cells release IL-33 in response to stress or damage caused by allergens, viruses, cigarette smoke, or air pollution.
Sanofi presented phase III clinical study protocol No. LTS18133 version No. 1 dated October 24, 2023. Following in-depth deliberation, the committee recommended granting permission for Sanofi to conduct the trial as presented by the firm.
Sanofi and Regeneron aim to revolutionize COPD treatment by investigating the impact of inflammation types using biologics Dupixent and Itepekimab. Dupixent targets IL-4 and IL-13 pathways, focusing on those with type 2 inflammation. Itepekimab inhibits IL-33, addressing broad inflammation.