Sanofi, Regeneron to move dupilumab into late-stage asthma studies on positive data

Sanofi and Regeneron Pharmaceuticals announced Tuesday that a Phase IIb study of the experimental drug dupilumab in adults with uncontrolled moderate-to-severe asthma met its primary endpoint. Elias Zerhouni, president of global R&D at Sanofi, said "based on these results, we plan to move dupilumab into Phase III clinical development in patients with moderate-to-severe uncontrolled asthma."

The trial randomised 776 adults with moderate-to-severe uncontrolled asthma to receive one of four doses of dupilumab or placebo, with subjects continuing to use a stable medium- or high-dose inhaled corticosteroid and long-acting beta agonist combination product. The companies noted that approximately 40 percent of patients had high eosinophils across the dose groups.

A pre-specified interim analysis showed that the three highest doses of dupilumab significantly improved FEV1 from baseline to week 12 in patients with high blood eosinophils, compared to placebo, meeting the study's main goal. Sanofi and Regeneron said that two doses of dupilumab also showed a significant improvement in mean percent change in FEV1, as well as a reduction in severe exacerbations, in both the high eosinophils and overall study population. Results demonstrated that in both the high eosinophils patient group and overall patient group, dupilumab reduced the adjusted annualised rate of severe exacerbations by between 64 percent and 75 percent, versus placebo.

Zerhouni remarked "many have thought that targeting the Th2 pathway in asthma would limit benefit to a subset of asthmatics, such as those with high eosinophils. In this study, blocking IL-4/IL-13 signalling with dupilumab improved lung function and reduced severe exacerbations in the broader study population." The drugmakers noted that the final analyses on exacerbations and safety will occur at 24 weeks, with patients being followed for 16 weeks after treatment. Full results from the trial will be presented at a future medical meeting.

Dupilumab, a fully-human monoclonal antibody that blocks signalling from both IL-4 and IL-13, is also being developed by Sanofi and Regeneron for atopic dermatitis and chronic sinusitis with nasal polyps. Last month, the companies initiated a Phase III trial of the therapy in atopic dermatitis and announced in September that the drug met all of the primary and secondary endpoints of a Phase IIa study in patients with moderate-to-severe chronic sinusitis with nasal polyps.

Analysts predict that dupilumab could be launched in 2019, with Berenberg Bank analyst Alistair Campbell estimating that the drug could garner annual sales of $1.5 billion by 2025, if mid-stage data are replicated in Phase III studies. For related analysis, see ViewPoints: Sanofi, Regeneron throw their respiratory hat into a competitive race.

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