Sanofi has unveiled promising new data from its respiratory pipeline, highlighting significant progress in addressing unmet needs in asthma and other respiratory conditions. The pharmaceutical giant today released preliminary phase 2 results for amlitelimab in adults with moderate-to-severe asthma, demonstrating the drug's potential as a breakthrough treatment for patients with heterogeneous inflammatory asthma.
The TIDE-Asthma phase 2 study (NCT05421598) evaluated amlitelimab as an add-on therapy in 437 adults with moderate-to-severe asthma. While the primary endpoint of annualized exacerbation rate at week 48 was not met at the highest dose level, the drug showed nominally significant and clinically meaningful reductions in asthma exacerbations at the medium dose tested, with a numerically greater reduction at the high dose by week 60.
Particularly noteworthy were the results in a specific patient subgroup defined by biomarkers (eosinophils ≥300 cells/ml and elevated neutrophils), where amlitelimab demonstrated nominally significant improvements in exacerbations with a reduction exceeding 70%, along with improved lung function and asthma control at week 60.
"We are pleased by the significant progress we have made with our pipeline across respiratory indications," said Houman Ashrafian, Executive Vice President and Head of Research & Development at Sanofi. "In asthma, amlitelimab shows potential as an effective, long-acting medicine, including in patients with moderate-to-severe heterogenous inflammation. If the preliminary effect we have seen is confirmed in phase 3 studies, amlitelimab could become a differentiated treatment option in asthma."
Amlitelimab: A Novel Approach to Immune Regulation
Amlitelimab represents a novel therapeutic approach with its unique non-depleting mechanism of action targeting OX40-Ligand, a key immune regulator. This mechanism aims to durably restore immune balance with sustained effect and infrequent dosing.
In the TIDE-Asthma study, patients received treatment every four weeks for the first 24 weeks, followed by every 12 weeks for the remaining 36 weeks. The durable efficacy demonstrated through 60 weeks of treatment supports a quarterly maintenance dosing schedule, which could significantly improve treatment adherence compared to more frequently dosed medications.
The safety profile was consistent with previous studies across indications, with no new safety signals identified throughout the 60-week treatment period. The incidence of treatment emergent adverse effects (TEAEs) and treatment discontinuation rates were similar between the amlitelimab and placebo groups. The most frequent TEAEs (≥5% in any arm) more common (≥1%) than placebo were COVID-19, bronchitis, acute sinusitis, and headache, all of which were mild-to-moderate in severity and non-serious.
Expanding Respiratory Portfolio
Beyond amlitelimab, Sanofi is advancing several other promising candidates in its respiratory pipeline:
Lunsekimig, a novel Nanobody VHH® that simultaneously targets IL13 and TSLP, is being explored in a broad population of asthma patients regardless of their inflammation and severity status. The readout of the AIRCULES phase 2 study (NCT06102005) in moderate to severe asthma is anticipated in 2026, while the AIRLYMPUS phase 2 study (NCT06676319) in high-risk asthma was initiated in Q4 2024.
Sanofi is also expanding lunsekimig's potential applications, with a phase 2 study in patients with chronic rhinosinusitis with nasal polyps (NCT06454240) expected to read out in 2026, and a phase 2/3 study in COPD anticipated to begin in 2025.
Itepekimab, developed in partnership with Regeneron, is a fully human monoclonal antibody that binds to and inhibits IL33, an initiator and amplifier of broad inflammation in respiratory diseases. The drug is currently being evaluated in COPD through two phase 3 studies, AERIFY-1 (NCT04701983) and AERIFY-2 (NCT04751487), with readouts anticipated in H2 2025.
The itepekimab clinical program is expanding beyond COPD into chronic rhinosinusitis, with two phase 3 studies in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), CEREN 1 (NCT06834347) and CEREN 2 (NCT06834360), and one phase 2 study in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) (NCT06691113) initiated in Q1 2025. Additionally, a phase 2 study (NCT06280391) in bronchiectasis is underway, with results expected in 2026.
Addressing Significant Unmet Needs
Respiratory diseases represent a substantial global health burden. Asthma affects approximately 262 million people worldwide and causes 455,000 deaths annually, according to the World Health Organization. COPD is the third leading cause of death globally, affecting more than 300 million people.
Despite available treatments, many patients with moderate-to-severe asthma continue to experience symptoms and exacerbations that significantly impact their quality of life. Patients with heterogeneous inflammatory asthma, in particular, represent an underserved population with limited effective treatment options.
The promising results from Sanofi's respiratory pipeline, particularly the amlitelimab data in heterogeneous inflammatory asthma, suggest potential new options for these difficult-to-treat patient populations. If confirmed in phase 3 studies, these therapies could represent significant advances in the management of respiratory diseases.
Full and final results from the TIDE-Asthma study will be presented at a forthcoming medical meeting, providing the scientific community with a more comprehensive understanding of amlitelimab's potential in asthma treatment.
