Regeneron, Sanofi tout topline Ph3 data for injectable asthma drug

Sanofi (NYSE:SNY) and Regeneron (NSDQ:REGN) touted data today from the pivotal Phase III trial of dupilumab in a group of patients with uncontrolled, persistent asthma.

The drug is already approved for adults with certain forms of eczema. The two companies said they plan to seek FDA approval of dupilumab in asthma by the end of the year.

The Quest trial met its two primary endpoints, which included the yearly rate of severe exacerbation events after 1 year and the absolute change from baseline in pre-bronchodilator forced expiratory volume over one second at 12 weeks.

Dupilumab, which is an injectable monoclonal antibody, reduced severe asthma attacks and boost lung function when added to standard therapies, according to the data. After 1 year, in the group receiving 300 milligrams of the drug, dupilumab cut severe asthma attacks by 46% in the overall population.

The drug worked even better in patients with higher counts of a white blood cell commonly found in patients who have a hard time controlling their asthma – eosinophils. Patients with 150 eosinophilic cells per microliter of blood experienced a 60% cut in severe asthma attacks and an 11% increase in lung function.

Study participants with 300 eosinophilic cells per microliter saw a 67% reduction in severe asthma attacks and an 18% boost in lung function, the companies touted.

“Approximately one million U.S. adults and adolescents live with uncontrolled, persistent asthma, and continue to experience serious asthma attacks, despite taking an intensive regimen of standard therapies,” Regeneron president & chief scientific officer Dr. George Yancopoulos said in prepared remarks. “Dupilumab has now demonstrated positive late-stage results in two serious allergic diseases – asthma and atopic dermatitis – with robust efficacy and an extensive safety database. These results continue to support our hypothesis that the IL4/IL13 pathway is a critical driver of allergic disease, and we remain committed to further investigating the IL-4/IL-13 pathway in other allergic diseases.”

“We believe that therapies like dupilumab, which focus on specific molecular pathways such as the Th2 pathway associated with multiple chronic allergic diseases, are important targets for further investigation,” Dr. Elias Zerhouni, Sanofi’s president of global R&D, added. “The positive data from this large second pivotal trial in uncontrolled persistent asthma, following the positive results of dupilumab in atopic dermatitis, further support this view in our opinion. We will work diligently with health authorities to bring this new application of dupilumab to the patients who most need it.”

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