Sanofi Advances Mid- to Late-Stage Respiratory Pipeline, Targeting Unmet Need in Asthma, COPD

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Sanofi announced significant progress across its mid- to late-stage respiratory pipeline, including promising Phase II data for amlitelimab in moderate-to-severe asthma, as well as upcoming clinical plans in chronic obstructive pulmonary disease (COPD) and bronchiectasis. In a press release, the company highlighted the promise of multiple assets for different disease states.

“We are pleased by the significant progress we have made with our pipeline across respiratory indications,” said Houman Ashrafian, EVP, head of research & development, Sanofi, in a press release.

In the randomized, double-blind, placebo-controlled, dose-ranging TIDE-Asthma study, investigators evaluated amlitelimab as an add-on therapy in 437 adults with moderate-to-severe asthma. All patients were treated with standard-of-care therapy, including medium-to-high doses of inhaled corticosteroids and up to two additional controller medications. Patients were randomly assigned in a 2:1:2:2 ratio to receive one of three dose levels of amlitelimab or placebo for the first 24 weeks, followed by dosing once every 12 weeks until week 60. The primary endpoint of the study was the annualized rate of severe asthma exacerbations, with key secondary endpoints that included lung function and asthma control.

While amlitelimab did not meet the primary endpoint at the highest dose, the medium dose achieved nominal statistical significance and clinically meaningful reductions in exacerbations, with the high dose showing numerically greater improvements by week 60. By that time point, the treatment also demonstrated strong results in patients with both high eosinophil and neutrophil levels, with exacerbations dropping by more than 70%.

Amlitelimab’s safety profile was consistent with findings from previous studies across multiple indications. Treatment-emergent adverse events (TEAEs) and treatment discontinuation rates were similar between treatment groups. The most common TEAEs in the amlitelimab groups were COVID-19, bronchitis, acute sinusitis, and headache, all of which were considered mild-to-moderate in severity.

Sanofi also provided updates on its broader respiratory portfolio. Lunsekimig, a candidate for asthma and COPD across inflammation phenotypes, is currently being evaluated in the Phase II AIRCULES and AIRLYMPUS studies, with readouts expected beginning in 2026. A Phase II/III study in patients with COPD is expected to launch later this year.

In collaboration with Regeneron, Sanofi announced the initiation of the Phase III CEREN 1 and CEREN 2 studies in patients with chronic rhinosinusitis with nasal polyps, along with a Phase II study in those without nasal polyps, all of which began in the first quarter of 2025. Additionally, the treatment is currently being evaluated in patients with COPD as part of the Phase III AERIFY-1 and AERIFY-2 studies, as well as the Phase II AERIFY-3. Data for all three trials are expected in the second half of 2025.¹

According to a study published by the National Center for Biotechnology Information, an estimated 545 million people were living with a respiratory condition globally, representing 7.4% of the total population, with the highest rates and premature mortality occurring in South Asia. Notably, the lowest mortality rates in both males and females were found in lowest in sub-Saharan Africa. Overall, global rates declined significantly between 1990 and 2017.²

“In asthma, amlitelimab shows potential as an effective, long-acting medicine, including in patients with moderate-to-severe heterogenous inflammation,” Ashrafian said. “If the preliminary effect we have seen is confirmed in Phase III studies, amlitelimab could become a differentiated treatment option in asthma. These data validate our strategy to advance innovative science and provide new solutions for patients with challenging-to-treat respiratory diseases.”

References

1. Press Release: Sanofi’s respiratory pipeline advances with new data in asthma and plans for new clinical studies in COPD. Sanofi. April 15, 2025. Accessed April 18, 2025. https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-15-05-00-00-3061368

2. Prevalence and attributable health burden of chronic respiratory diseases, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. PubMed. Accessed April 18, 2025. https://pmc.ncbi.nlm.nih.gov/articles/PMC7284317/#:~:text=Our%20finding%20that%20nearly%20545,to%20premature%20morbidity%20and%20mortality.