Positive news for Sanofi asthma drug
pharmafile | May 23, 2013 | News story | Sales and Marketing | Dupilumab, Regeneron, Sanofi, asthma
An asthma drug being developed by Sanofi and Regeneron Pharmaceuticals has performed well in a Phase IIa trial, reducing the exacerbations that patients experience.
Dupilumab targets the interleukin 4 receptor (IL-4R alpha), which modulates the signalling of both IL-4 and IL-13, which are in turn linked to inflammation.
More than 100 patients with moderate-to-severe, persistent asthma that was not well controlled with inhaled glucocorticosteroids (ICS) and long-acting beta agonists (LABA) – and who also had elevated blood or sputum eosinophils – were given the drug subcutaneously.
Patients had either dupilumab 300mg once a week for 12 weeks or placebo – plus ICS and LABA therapy for the first four weeks of the study, after which the LABA was withdrawn and the ICS removed between weeks six and nine.
In results presented at the American Thoracic Society 2013 International Conference, 23 patients (44.2%) receiving placebo had an asthma exacerbation compared to just three patients (5.8%) receiving dupilumab – an 87% reduction for those on the Sanofi/Regeneron drug.
“These positive Phase II results are very encouraging,” said Gianluca Pirozzi, Sanofi’s global project head. “Dupilumab is the first monoclonal antibody that demonstrated clinically meaningful activity by blocking the IL-4R alpha subunit and consequently, both IL-4 and IL-13 signalling.”
As well as significantly reducing exacerbations and daily symptoms, dupilumab also improved lung function. “We are eager to move forward with the clinical development program for dupilumab,” he went on.
The results are significant because many asthma patients are not adequately controlled, which means that their chances of poor clinical outcomes are increased.
“These encouraging data support the potential role of IL-4/IL-13 blockade in an important subset of asthma patients and warrant continued clinical investigation,” suggested Sally Wenzel, director of the Asthma Institute at the University of Pittsburgh and lead investigator of the trial.
The rate of adverse events, generally mild-to-moderate, was similar for both arms in the study.
Adam Hill
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