Sanofi Leader Says Phase 2 Findings Support Lunsekimig’s Potential As A New Treatment Option For Chronic Respiratory Conditions

Recent Phase 2 studies of lunsekimig, an investigational treatment for chronic respiratory diseases, have produced encouraging results. In two separate trials, the medicine achieved both its main and key secondary goals when compared with placebo. Lunsekimig is a novel bispecific Nanobody VHH composed of five linked antibody fragments. 

It is specifically engineered to block TSLP and IL-13 at the same time, two important inflammatory drivers known to cause tissue damage in asthma and other related conditions. Across the clinical studies, the treatment showed good tolerability and maintained an acceptable safety profile.

According to Houman Ashrafian, Executive Vice President and Head of Research and Development at Sanofi, the results reinforce the belief that lunsekimig’s dual-targeting mechanism may offer a new therapeutic option for people living with respiratory illnesses, including asthma. He also noted that the findings highlight the medicine’s potential to address multiple aspects of disease management through its unique mode of action.

In the AIRCULES phase 2b study (clinical study identifier NCT06102005), lunsekimig demonstrated statistically significant and clinically meaningful results in adult patients with moderate-to-severe asthma. This form of asthma is characterized by persistent symptoms and frequent flare-ups despite standard therapy. 

The treatment achieved its primary and key secondary endpoints, showing a clear reduction in asthma exacerbations and an improvement in lung function. Lung function was measured using pre-bronchodilator forced expiratory volume in one second (pre-BD FEV1), and the improvements observed indicate a meaningful benefit for patients struggling with reduced airflow.

The DUET phase 2a proof-of-concept study (clinical study identifier NCT06454240) evaluated lunsekimig in individuals with chronic rhinosinusitis with nasal polyps. In this study, the treatment reached its primary endpoint of reducing the nasal polyp score from baseline. It also met key secondary endpoints, including improvements in patient-reported nasal congestion or obstruction as well as changes in the Lund-Mackay CT score. All improvements were evaluated against placebo at Week 24 and point to the potential of lunsekimig to reduce polyp burden and relieve related symptoms.

A separate exploratory study, the VELVET phase 2b trial (clinical study identifier NCT06790121), examined lunsekimig in patients with moderate-to-severe atopic dermatitis. This study did not meet its primary endpoint, which was based on the percentage change from baseline in the eczema area and severity index (EASI) score. However, there were noticeable improvements in key secondary endpoints related to skin clearance. 

These included the proportion of patients achieving a 75 percent improvement in the EASI score (EASI-75) and the proportion achieving a score of 0 or 1 on the validated investigator global assessment scale for atopic dermatitis, indicating clearer or almost clear skin. While the main target was not achieved, these secondary findings suggest potential benefits for certain patients.

Across all three studies, lunsekimig was generally well tolerated. In the AIRCULES study, the most common treatment-emergent adverse events reported in five percent or more of participants who received at least one dose included nasopharyngitis, upper respiratory tract infection, headache, and dose-scheduling errors. 

In the DUET study, the most common adverse events occurring in five percent or more of treated participants included injection-site reactions or redness, viral upper respiratory tract infection, nasopharyngitis, nosebleeds, ear pain, and increased creatine phosphokinase levels. Importantly, in both AIRCULES and DUET, the rates of serious adverse events and discontinuations due to side effects were similar between the lunsekimig and placebo groups. In the VELVET study, the treatment continued to show a safety profile consistent with the earlier trials.

Full data from the AIRCULES, DUET, and VELVET studies are expected to be presented at forthcoming medical congresses, where more detailed analyses will be shared with the scientific community. Lunsekimig continues to advance through clinical development. It is currently being studied in the AIRLYMPUS phase 2 trial in individuals with high-risk asthma (clinical study identifier NCT06676319). 

The medicine is also being evaluated in two phase 3 trials, named PERSEPHONE (clinical study identifier NCT07190209) and THESEUS (clinical study identifier NCT07190222). As lunsekimig is still under investigation, neither its safety nor its effectiveness has been reviewed or approved by any regulatory authority.