US biotechnology company Regeneron Pharmaceuticals Inc (Nasdaq:REGN) and French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) on Friday announced results from two Phase 3 trials evaluating itepekimab for chronic obstructive pulmonary disease (COPD) in former smokers.

The AERIFY-1 trial met its primary endpoint, showing a statistically significant 27% reduction in moderate or severe exacerbations at 52 weeks, delivering a clinically meaningful benefit.

In contrast, the AERIFY-2 trial did not meet its primary endpoint, though some early improvements were observed. Both studies were conducted during the COVID-19 pandemic, which is thought to have contributed to lower-than-expected exacerbation rates and reduced statistical power.

Itepekimab was generally well tolerated across both trials, with safety profiles consistent with prior studies and similar rates of adverse events compared to placebo. Serious infection and mortality rates were comparable between treatment and placebo groups.

Regeneron and Sanofi are analysing the full dataset and intend to engage with regulatory authorities to determine next steps for itepekimab's development. Itepekimab is currently being evaluated in other trials, including chronic rhinosinusitis with and without nasal polyps, and non-cystic fibrosis bronchiectasis.

Itepekimab remains under clinical investigation and has not yet been approved by any regulatory body.