Sanofi and Regeneron release positive interim results of Phase IIb dupilumab trial

French drug major Sanofi (Euronext: SAN) and US biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN) have shared additional positive results from an interim analysis of a pivotal Phase IIb study of dupilumab in adult patients with moderate-to-severe asthma who are uncontrolled despite treatment with inhaled corticosteroids and long-acting beta agonists (ICS/LABA).

They had previously reported that the study met its primary endpointof improving lung function in asthma patients with high blood eosinophils counts (greater than or equal to 300 eosinophilic cells/microliter). Such high counts are thought to be a marker for patients more likely to have ‘atopic’ or ‘allergic’ asthma. Now new data on secondary endpoints presented at the American Thoracic Society 2015 International Conference included positive results in study patients with low blood eosinophils (less than 300 eosinophilic cells/microliter) who are thought to be less likely to suffer from ‘allergic’ asthma and therefore less likely to respond to Th2 targeted therapies. Dupilumab is an investigational therapy in clinical development that inhibits signaling of IL-4 and IL-13, two cytokines required for the Th2 (or Type 2) immune response.

Could be used for FDA filing