Sanofi SA (NASDAQ:SNY) on Tuesday reported Phase 2 data for its experimental therapy lunsekimig in chronic respiratory diseases, highlighting meaningful improvements in asthma and nasal polyp patients, while showing mixed outcomes in a separate skin disorder study.

Strong Outcomes In Asthma Study

In the Phase 2b AIRCULES trial, lunsekimig met both its primary and key secondary endpoints, demonstrating statistically significant reductions in exacerbations and improved lung function.

The trial assessed lung performance using pre-bronchodilator forced expiratory volume (FEV1).

The study included adults with moderate-to-severe asthma, a population characterized by persistent symptoms and frequent flare-ups despite standard treatments.

The results suggest the drug may address underlying inflammatory pathways driving disease severity.

Positive Results In Nasal Polyp Study

Sanofi also reported encouraging findings from the Phase 2a DUET study in chronic rhinosinusitis with nasal polyps.

Lunsekimig achieved its primary endpoint, showing a reduction in nasal polyp size.

Key secondary measures also improved, including nasal congestion scores and imaging-based assessments using the Lund-Mackay CT scale at Week 24, reinforcing the therapy's potential across related inflammatory conditions.

Atopic Dermatitis Study Misses Goal

However, results from the exploratory Phase 2b VELVET study in atopic dermatitis were mixed.

The trial did not meet its primary endpoint, measuring percentage improvement in eczema severity scores.

Despite this, patients showed gains in secondary measures, including higher rates of skin clearance and improvements in investigator-assessed disease severity, indicating some clinical activity.

Sanofi Safety Profile

Across all studies, lunsekimig demonstrated a generally favorable safety profile.

Common adverse events included respiratory infections, headaches, and injection site reactions, with serious events occurring at similar rates as placebo.

Lunsekimig is a bispecific Nanobody designed to simultaneously inhibit TSLP and IL-13, two key inflammatory drivers linked to asthma and related diseases.

Sanofi Ongoing Development

The drug continues to advance through clinical development, with ongoing studies including the Phase 2 AIRLYMPUS trial in high-risk asthma and Phase 3 PERSEPHONE and THESEUS trials.

Competitive Landscape

In May 2025, Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi reported mixed data from two COPD trials evaluating itepekimab.

Regeneron and Sanofi's Dupixent gained FDA approval for COPD in November 2024, marking its sixth U.S. indication since its first use for atopic dermatitis seven years ago.

In January, Upstream Bio Inc. (NASDAQ:UPB) shared positive results from the Phase 2 VALIANT trial of verekitug, a treatment for severe asthma.

The VALIANT trial demonstrated statistically significant reductions in the annualized asthma exacerbation rate (AAER) of 56% for the 100 mg every 12 weeks (quarterly) dosing and 39% for the 400 mg every 24 weeks (six months) dosing compared to placebo.

In December 2025, the U.S. Food and Drug Administration approved GSK plc's (NYSE:GSK) Exdensur (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma.

SNY Stock Price Activity: Sanofi shares were up 0.95% at $48.05 during premarket trading on Tuesday, according to Benzinga Pro data.

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