Sanofi’s plans to submit itepekimab to regulators for approval this year have been put on hold after a recent phase 3 trial failed to meet expectations. The drug, in collaboration with Regeneron, was designed to reduce exacerbations of chronic obstructive pulmonary disease (COPD) in patients. However, the results from the AERIFY-2 trial showed only a 2% reduction in moderate or severe exacerbations.
Sanofi cited lower-than-anticipated total number of exacerbations as one reason for the underwhelming results. The company also noted that enrollment occurred during the COVID pandemic, which may have contributed to lower rates. Adverse events were “generally comparable” between itepekimab and placebo cohorts.
The failure of AERIFY-2 is a significant setback for itepekimab, which was previously expected to launch in 2026. Sanofi’s head of R&D stated that while the results from one trial were encouraging, more exploration is needed to fully understand the data and its role in COPD treatment.
Sanofi will continue evaluating itepekimab in ongoing phase 2 and 3 trials for other indications, including rhinosinusitis with nasal polyps and bronchiectasis. Regeneron remains committed to its broader development program, citing potential learnings from AERIFY-2 as a way forward.
Source: https://www.fiercebiotech.com/biotech/sanofi-regenerons-il-33-drug-fails-1-2-copd-studies-derailing-approval-plans