Core Viewpoint - Sanofi announced preliminary data from the phase II TIDE-Asthma study for its anti-OX40L mAb, amlitelimab, which showed mixed results in treating moderate-to-severe asthma, alongside updates on other respiratory pipeline candidates [1][2][3]. Group 1: Amlitelimab Study Results - The highest dose of amlitelimab did not meet the primary endpoint of annualized exacerbation rate at week 48, while the medium dose showed nominal significance [2]. - At week 60, the medium dose demonstrated clinically meaningful reductions in asthma exacerbations, with a greater reduction observed at the high dose level [3]. - Amlitelimab also led to significant improvements in lung function and asthma control, which were secondary endpoints of the study [3]. Group 2: Other Respiratory Pipeline Developments - Sanofi is developing itepekimab in partnership with Regeneron Pharmaceuticals, currently in two phase III studies for chronic rhinosinusitis with nasal polyps [5]. - Itepekimab is also being evaluated for chronic obstructive pulmonary disease (COPD), with data expected in the second half of 2025 [6]. - Additional studies are ongoing for itepekimab in bronchiectasis and for lunsekimig in high-risk asthma and moderate-to-severe asthma, with data from these studies anticipated in 2026 [8][9]. Group 3: Market Performance - Year to date, Sanofi's shares have increased by 4.9%, contrasting with a 4.9% decline in the industry [4].

Core Insights - Sanofi has made significant advancements in its respiratory pipeline, particularly with the drug amlitelimab for asthma, showing promising preliminary phase 2 results [1][2][3] Group 1: Amlitelimab in Asthma - The TIDE-Asthma phase 2 study revealed that while the primary endpoint of annualized exacerbation rate at week 48 was not met at the highest dose, there were nominally significant reductions in asthma exacerbations at medium and low doses [2] - Amlitelimab demonstrated a more than 70% reduction in exacerbations in a biomarker-defined patient subgroup, indicating its potential to address unmet needs in asthma treatment [2][3] - The treatment regimen involved administration every four weeks for the first 24 weeks, followed by every 12 weeks, supporting a quarterly maintenance dosing schedule [3][11] Group 2: Future Clinical Studies - A phase 3 program for amlitelimab is currently being planned, with full results from the TIDE-Asthma study to be presented at an upcoming medical meeting [2][4] - Sanofi is also exploring lunsekimig in chronic obstructive pulmonary disease (COPD) and chronic rhinosinusitis, with phase 2 study results anticipated in 2026 [5][6] - Itepekimab is expanding its clinical studies into chronic rhinosinusitis and bronchiectasis, with phase 3 readouts expected in H2 2025 [7][9][8] Group 3: Mechanism of Action and Safety Profile - Amlitelimab operates through a unique non-depleting mechanism targeting OX40-Ligand, aiming to restore immune balance with infrequent dosing [3][10] - The safety profile of amlitelimab was consistent with previous studies, with no new safety signals identified, and treatment emergent adverse effects were similar between amlitelimab and placebo groups [3][11]

Sanofi’s respiratory pipeline advances with new data in asthma and plans for new clinical studies in COPD New phase 2 data for amlitelimab show efficacy in heterogeneous inflammatory asthmaLunsekimig now targeting chronic rhinosinusitis and COPD in addition to asthmaItepekimab expanding into chronic rhinosinusitis along with COPD and bronchiectasis; phase 3 readouts in COPD in H2 2025 and bronchiectasis in 2026 Paris, April 15, 2025. Sanofi today shared new progress from its mid- to late-stage respiratory ...