Sanofi and Regeneron are putting their investigational monoclonal antibody dupilumab into late-stage trials for moderate to severe asthma on the back of positive Phase IIb data.
In the study, which enrolled 776 adults with moderate-to-severe uncontrolled asthma, dupilumab showed a reduction in the annual rate rate of severe exacerbations compared to placebo by 64% to 75%. The drug is an interleukin 4 receptor which modulates signalling of both the IL-4 and IL-13 proteins, which are linked to inflammation.
George Yancopoulos, Regheneron chief scientific officer, said that patients with moderate-to-severe asthma “have a high unmet medical need, often struggling with daily symptoms and recurring asthma attacks, despite the use of inhaled steroids, long-acting beta agonists and rescue medications”. He added that the trial is encouraging “given the positive results observed on the most clinically meaningful endpoints – FEV1, a key measure of lung function, and asthma exacerbations – were seen on top of ongoing background therapy”.
Sanofi R&D chief Elias Zerhouni noted that many have thought this approach would limit benefit to a subset of asthmatics, such as those with high eosinophils but the data revealed dupilumab’s effectiveness in the broader study population. “Based on these results, we plan to move dupilumab into Phase III”, he added.
As well as asthma, dupilumab is also being investigated for atopic dermatitis and chronic sinusitis with nasal polyposis. It is seen as a key drug in Sanofi’s portfolio.
