Sanofi Highlights Potential of Lunsekimig as New Treatment Option Following Strong Phase 2 Study Outcomes

(IN BRIEF) Sanofi has announced positive phase 2 clinical results for lunsekimig, a novel bispecific therapy targeting key inflammatory pathways in respiratory diseases. The treatment successfully met primary and key secondary endpoints in studies involving moderate-to-severe asthma and chronic rhinosinusitis with nasal polyps, demonstrating improved lung function and reduced disease symptoms. While the therapy did not meet its primary endpoint in an atopic dermatitis study, it showed promising results in secondary measures of skin improvement. Lunsekimig was generally well tolerated across all trials, with a safety profile comparable to placebo. The findings support further development of the therapy, with additional clinical trials underway, highlighting its potential as a new treatment option for patients with complex inflammatory conditions.

(PRESS RELEASE) PARIS, 7-Apr-2026 — /EuropaWire/ — Sanofi has reported positive results from multiple phase 2 clinical studies evaluating lunsekimig, a novel investigational therapy targeting inflammatory pathways in respiratory diseases. The treatment met primary and key secondary endpoints in studies focused on asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), while showing mixed results in atopic dermatitis.

Lunsekimig is a bispecific Nanobody® VHH composed of five linked antibody fragments, engineered to simultaneously inhibit thymic stromal lymphopoietin (TSLP) and interleukin-13 (IL-13), both of which play critical roles in driving inflammation and tissue damage in respiratory conditions. Across all trials, the therapy demonstrated an acceptable safety profile and was generally well tolerated.

Houman Ashrafian, Executive Vice President and Head of Research and Development at Sanofi, highlighted the significance of the findings, noting that the dual-targeting approach of lunsekimig could represent a new therapeutic option for patients with respiratory diseases, particularly asthma. He emphasized that the results support the potential of the treatment to address multiple aspects of disease pathology through its unique mechanism.

In the AIRCULES phase 2b study, lunsekimig achieved both its primary and key secondary endpoints in patients with moderate-to-severe asthma, regardless of biomarker status. The therapy delivered statistically significant reductions in exacerbations and improved lung function, as measured by pre-bronchodilator forced expiratory volume in one second (FEV1). The study included adult patients experiencing persistent symptoms and frequent flare-ups despite existing treatments.

Similarly, the DUET phase 2a proof-of-concept study demonstrated positive outcomes in patients with CRSwNP. The treatment met its primary endpoint, showing a reduction in nasal polyp size, and also achieved key secondary endpoints related to nasal congestion and imaging-based assessments, including improvements in Lund-Mackay CT scores at 24 weeks.

In contrast, the exploratory VELVET phase 2b study, which evaluated lunsekimig in moderate-to-severe atopic dermatitis, did not meet its primary endpoint related to overall disease severity reduction. However, the study did report improvements in secondary measures, including skin clearance indicators such as EASI-75 and validated investigator global assessment scores.

Safety findings across all three studies were consistent, with lunsekimig generally well tolerated. The most frequently reported treatment-emergent adverse events included nasopharyngitis, upper respiratory tract infections, headaches, and injection site reactions. Rates of serious adverse events and discontinuations were comparable between treatment and placebo groups.

Sanofi plans to present detailed data from the AIRCULES, DUET, and VELVET studies at upcoming medical conferences. The company is continuing the clinical development of lunsekimig, with ongoing studies including the AIRLYMPUS phase 2 trial in high-risk asthma and the PERSEPHONE and THESEUS phase 3 trials. The therapy remains investigational and has not yet been evaluated by regulatory authorities for approval.

About asthma
Asthma is one of the most common chronic diseases worldwide, with an estimated 262 million patients diagnosed globally as of 2019. However, despite several available therapies, more than 50% of patients have asthma that is not well controlled. A significant unmet need persists for treatments that prevent and reduce asthma exacerbations, which profoundly diminish patients’ quality of life, disrupt daily activities, and contribute substantially to healthcare resource utilization.

About CRSwNP
CRSwNP is a persistent inflammatory disease of the nose and sinuses characterized by the presence of soft, noncancerous growths, called nasal polyps, in the nasal passages. Individuals with CRSwNP often experience symptoms such as nasal congestion, facial pressure, and a reduced sense of smell, which can significantly impact their quality of life. The majority of patients with CRSwNP have comorbid asthma, which increases in frequency with severity of the disease.

About the AIRCULES study
AIRCULES was a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b study to evaluate the efficacy, safety, and tolerability of subcutaneous lunsekimig added to standard of care in adult patients with moderate-to-severe asthma across the range of FeNO (fractional exhaled nitric oxide) and eosinophil values. Lunsekimig was administered in multiple dosing regimens, and the primary endpoint was the annualized rate of asthma exacerbation events over 48 weeks. The key secondary endpoint evaluated lung function improvement, as measured by pre-BD FEV1 at Week 48. Lung function was assessed indirectly by measuring the volume of air a patient can exhale forcefully in one second. The study included sites across the US, Canada, Argentina, Brazil, Chile, China, India, Israel, Japan, Mexico, South Africa, South Korea, Turkey, and the UK.

About the DUET study
DUET was a randomized, double-blind, placebo-controlled, parallel-group phase 2a study designed to evaluate the efficacy, safety, and tolerability of subcutaneous lunsekimig in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Key objectives include measuring the efficacy and safety of lunsekimig compared to placebo over 24 weeks. The primary endpoint was change in nasal polyps score from baseline at Week 24 through bilateral endoscopy and the key secondary endpoints were change from baseline in patient-reported nasal congestion/obstruction score and change from baseline in LMK-CT score, both at Week 24. The study included sites across the US, Argentina, Belgium, Bulgaria, Poland, and the UK.

About the VELVET study
VELVET was a randomized, double-blind, placebo-controlled, multicenter exploratory study to assess the efficacy and safety of three subcutaneous dose regimens of lunsekimig in adult patients with moderate-to-severe atopic dermatitis. Key objectives include measuring the efficacy and safety of subcutaneous lunsekimig compared to placebo over 24 weeks. Lunsekimig was administered in three dosing regimens, and the primary endpoint was the percent change in EASI score from baseline at week 24. The study included sites across the United States, Czechia, Japan, and Poland.

About lunsekimig
Lunsekimig is a novel, pentavalent Nanobody® VHH that combines bispecific targeting of TSLP, an upstream initiator of inflammation and IL-13, a downstream cytokine causing tissue organ damage in respiratory diseases. As a pentavalent Nanobody® VHH (variable heavy-chain domains of a heavy-chain antibody), lunsekimig is made of five linked antibody fragments designed to simultaneously block TSLP and IL-13, which drive airway inflammation and can contribute to tissue damage in certain diseases and bind albumin for longer half-life. Pre-clinical research suggests that the combination of these targets simultaneously can potentially lead to additive and synergistic benefits in immune-mediated diseases such as asthma.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Sanofi forward-looking statements

This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future events and economic performance. Words such as “expect,” “anticipate,” “believe,” “intend,” “estimate,” “plan,” “can,” “contemplate,” “could,” “is designed to,” “may,” “might,” “potential,” “objective,” “attempt,” “target,” “project,” “strategy,” “strive,” “desire,” “predict,” “forecast,” “ambition,” “guideline,” “seek,” “should,” “will,” “goal,” or the negative of these, and similar expressions are intended to identify forward-looking statements. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the U.S Food and Drug Administration or the European Medicines Agency, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates; the fact that product candidates if approved may not be commercially successful; unexpected regulatory actions or delays, or government regulation generally; authorities’ decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug prices including “most favored nation” pricing for State Medicaid programs; the future approval and commercial success of therapeutic alternatives; Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general; risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation; trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the French Markets Authority (AMF) made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2025 or contained in our periodic reports on Form 6-K. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties and assumptions, you should not place undue reliance on any forward-looking statements contained herein.

Sanofi Highlights Potential of Lunsekimig as New Treatment Option Following Strong Phase 2 Study Outcomes

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