- Sanofi SA and Regeneron Pharmaceuticals Inc. said Monday their jointly developed inflammation blocker Dupixent reduced severe asthma attacks and improved lung function in a late-stage study, a clinical result that should advance the drugmakers' plans to build a blockbuster franchise around the treatment.
- When added to standard therapies, Dupixent lowered so-called asthma exacerbations by 46% across all patients, and by as much as 67% in higher-risk patients over the course of the year-long trial.
- Sanofi and Regeneron expect Dupixent — already approved in the U.S. for atopic dermatitis — to become a major driver of future revenue growth. Yet, the inflammation blocker could face stiffer competition in asthma, where treatments from GlaxoSmithKline plc and Teva Pharmaceutical Industries Ltd. are already on market.
Sanofi and development partner Regeneron believe the cellular pathway targeted by Dupixent plays a role in several conditions characterized by type 2 inflammation, from atopic dermatitis to nasal polyps.
Success in asthma further validates that approach, opening up an opportunity for the drugmakers to quickly expand the addressable market for Dupixent.
"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," said George Yancopoulos, chief scientific officer at Regeneron in a statement.
Sanofi and Regeneron tested Dupixent in patients with uncontrolled, persistent asthma who were already on medium- or high-dose inhaled corticosteroids and up to two additional controller medicines.
Dupixent was particularly effective in reducing asthma attacks among patients with elevated levels of eosinophilic cells, which are thought to be correlated with poorer control of asthma symptoms and higher attack rates.
For patients with 150 eosinophilic cells/microliter or greater, 300 mg of Dupixent added to standard therapy reduced asthma exacerbations by 60%. That rate reduction ticked higher to 67% among patients with 300 eosinophilic cells/microliter or greater.
After 12 weeks on therapy, lung function as measured by mean change in forced expiratory volume over one second (FEV1) also improved.
Sanofi and Regeneon plan to submit Dupixent for regulatory approval in asthma by the end of the year, moving quickly to capitalize on the clinical success.
Approval would put Dupixent in competition with GlaxoSmithKline's biologic drug Nucala (mepolizumab) and Teva's Cinqair (reslizumab). Sanofi and Regeneron could also face a new rival in AstraZeneca and Amgen's experimental tezepelumab, which notched a similarly impressive reduction in annual attack rates among patients with severe asthma still uncontrolled by standard therapy.
Unlike other asthma drugs, tezepelumab blocks an "upstream" target known as thymic stromal lymphopoietin, or TSLP. Inhibiting this cytokine could block the release of other inflammatory markers such as IL-4, IL-5 and IL-13 — potentially making tezepelumab effective in a broader range of patients.
Tezepelumab's results, however, were from a Phase 2b study, and it's unclear how quickly further development will move forward.