A Phase 2 proof-of-concept trial evaluating an investigational antibody met its primary endpoint after significantly reducing loss of asthma control and improving lung function compared to a placebo.
The trial, which was undertaken by Sanofi and Regeneron Pharmaceuticals, also met a key secondary endpoint.
In this endpoint, the REGN3500 monotherapy significantly improved lung function compared to a placebo.
REGN3500 is a fully-human monoclonal antibody that inhibits interleukin-33 (IL-33), a protein that is believed to play a key role in type 1 and type 2 inflammation.
Preclinical research showed REGN3500 blocked several markers of both types of inflammation.
In moderate-to-severe asthma, there can be multiple sources of underlying inflammation that new therapies may help address.
In the trial, the greatest improvement was observed in patients with blood eosinophil levels ≥300 cells/microliter.
Patients treated with Dupixent (dupilumab) monotherapy did numerically better than REGN3500 across all endpoints, although the trial was not powered to show differences between active treatment arms.
The combination of REGN3500 and Dupixent also did not demonstrate increased benefit compared to Dupixent monotherapy in this trial.