French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) on Tuesday reported new clinical data and announced expanded development plans across its respiratory pipeline, including asthma, chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis and bronchiectasis.
Preliminary phase 2 results from the TIDE-Asthma study show that amlitelimab demonstrated clinically meaningful efficacy in adults with heterogeneous inflammatory asthma, with reductions in exacerbation rates and improved lung function and asthma control, including in biomarker-defined subgroups.
Amlitelimab's durable effect and favourable safety profile support a quarterly maintenance dosing schedule. A phase 3 programme is currently being planned.
Lunsekimig, also in Sanofi's pipeline, is advancing in asthma and chronic rhinosinusitis, with data readouts expected in 2026 and a phase 2/3 COPD study set to begin in 2025.
Itepekimab, developed in partnership with US biotechnology company Regeneron Pharmaceuticals Inc (Nasdaq:REGN), is progressing through multiple phase 3 and phase 2 studies in chronic rhinosinusitis, COPD and bronchiectasis.
Readouts for itepekimab's COPD trials AERIFY-1, AERIFY-2 and AERIFY-3 are expected in the second half of 2025, while results from its bronchiectasis study are anticipated in 2026.
These developments highlight Sanofi's strategy to broaden its respiratory portfolio through targeted immunomodulation and data-driven expansion into high-need indications.
Mabwell's B7-H3-targeting ADC clinical trial application receives Chinese regulatory approval
Dupixent receives approval in Japan as first biologic for COPD treatment
Vast Therapeutics' ALX1 drug candidate granted QIDP designation by US FDA
Actinium Pharmaceuticals signs Ac-225 radioisotope agreement with Eckert & Ziegler
GSK's Nucala (Mepolizumab) COPD application accepted by EMA
Everest Medicines' EVM14 IND application receives US FDA approval
Clover Biopharmaceuticals' SCB-1019 IND application receives US FDA approval
CStone Pharmaceuticals submits Type II variation application to EMA for sugemalimab
Hikma announces Health Canada approval of KLOXXADO Nasal Spray for opioid overdose treatment
Johnson & Johnson reports breakthrough overall survival data for EGFR-mutated lung cancer treatment
Altesa BioSciences granted US regulatory approval for vapendavir clinical trials
Black Diamond Therapeutics and Servier agree global licensing deal for BDTX-4933
AstraZeneca secures EU approval for Imfinzi in limited-stage small cell lung cancer