Sanofi has released preliminary results from its Phase 2 TIDE-Asthma study evaluating Amlitelimab, an investigational monoclonal antibody, in adults with moderate-to-severe asthma. While the study did not meet its primary endpoint at the highest dose level, Amlitelimab demonstrated clinically meaningful efficacy in certain patient subgroups.
Sanofi has released preliminary results from its Phase 2 TIDE-Asthma study evaluating Amlitelimab, an investigational monoclonal antibody, in adults with moderate-to-severe asthma. While the study did not meet its primary endpoint at the highest dose level, Amlitelimab demonstrated clinically meaningful efficacy in certain patient subgroups.
The primary goal of the study was to assess the annualized rate of asthma exacerbations at week 48. This endpoint was not achieved at the highest dose, leading to nominal significance at medium and low doses.
However, treatment with Amlitelimab resulted in nominally significant and clinically meaningful reductions in asthma exacerbations at the medium dose and a numerically greater reduction at the high dose by week 60.
Additionally, improvements in lung function and asthma control were observed. Notably, in a biomarker-defined subgroup of patients with elevated eosinophils (≥300 cells/μL) and neutrophils, Amlitelimab led to a reduction of more than 70% in exacerbations, along with improvements in lung function and asthma control at week 60.
These findings suggest that Amlitelimab may offer a new treatment avenue for patients with heterogeneous inflammatory asthma. Sanofi is planning a Phase 3 program to further investigate Amlitelimab’s potential in this patient population.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. For personal health concerns or treatment options, please consult a qualified healthcare professional.
