Dupixent pushes towards a big new use

Success in the Boreas study is a big step forward for Sanofi/Regeneron’s Dupixent in a potentially large new setting: chronic obstructive pulmonary disease. The statistically significant 30% reduction in exacerbations, versus placebo, easily beat the mid-teens range that analysts at Wolfe Research said would be required for a clinically meaningful result. With Sanofi trading 5% higher in a down market, and Regeneron opening up 7%, the topline data were clearly stronger than many expected. Hopes were low because biologicals have previously failed in the progressive lung condition. Selecting for patients with an eosinophilic phenotype was presumably the key here, though it is as yet unknown whether the result was driven by former or current smokers; the study recruited both patient types. Either way, Dupixent probably needs to hit in a second identical trial before approvals can be sought; Notus reports in 2024. Past COPD disappointments mean a similar result is far from guaranteed, though the strength of the signals in Boreas will raise hopes. But it will be some years before the door to this potentially multibillion-dollar market is fully opened, and by then other biologicals could also be knocking.

Dupixent in COPD: the Boreas data so far
Primary endpoint: annualised exacerbation rate  30% reduction vs placebo (p=0.0005)
Key secondary endpoints:  
Lung function (FEV1) improvement from baseline at 12 weeks 160ml at 12 weeks compared to 77ml for placebo (p<0.0001)
Lung function (FEV1) improvement from baseline at 52 weeks  Improvements sustained (p=0.0003)
Note: Dupixent met all endpoints tested in the hierarchy, including improvement in patient-reported health-related quality of life scales. Source: company press release. 

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