Sanofi tempers its OX40 expectations in asthma after mid-stage miss

Title

Sanofi Adjusts OX40 Asthma Hopes After Phase 2 Amlitelimab Miss, Cites Promise in Select Patients

Keywords

Sanofi
amlitelimab
OX40-ligand
asthma
phase 2 clinical trial
TIDE-Asthma
moderate-to-severe asthma
asthma exacerbations
biomarker subgroup
respiratory pipeline
clinical development
immune modulation

Key Facts

Sanofi's amlitelimab, an anti-OX40-ligand monoclonal antibody acquired via the Kymab deal, failed to meet the primary endpoint of reducing severe asthma exacerbations at the highest dose in its phase 2 TIDE-Asthma trial for moderate-to-severe asthma1 2 3 4 7 8.
At medium dose, amlitelimab showed “nominally significant and clinically meaningful” reductions in asthma exacerbations, with improved lung function and asthma control in the broader study population1 2 7 8.
In a biomarker-defined subgroup (patients with eosinophils ≥300 cells/μl and elevated neutrophils), the drug achieved a >70% reduction in exacerbations at week 60, along with improvements in lung function and asthma control1 2 7 8.
The missed primary endpoint at the highest dose has led Sanofi to temper broad expectations for the OX40-ligand pathway in asthma, pivoting focus to the notable efficacy signals in specific patient populations3.
Amlitelimab demonstrated a favorable safety profile, with adverse events similar to placebo and generally mild-to-moderate in severity1 8.
Despite the setback, Sanofi plans to initiate a phase 3 program for amlitelimab in asthma, based on efficacy in targeted patient subgroups and secondary endpoints1 2 7 8.
This outcome mirrors Sanofi's approach with other immunology assets, leveraging differentiated mechanisms for broad and niche indications, as seen with its expansion of Dupixent beyond eczema and asthma2.
Amlitelimab remains in development for other immune-mediated diseases including atopic dermatitis, with promising phase 2 and 2b results supporting its potential as a best-in-class therapy for chronic inflammatory conditions5 6 9.

Sanofi’s recalibration of its OX40 targeting asthma ambitions follows the mixed phase 2 readout, sharpening its focus on defined subgroups and continued clinical investigation for potential breakthrough indications within challenging-to-treat respiratory populations1 2 3 7 8.