Success and Setbacks in Asthma Therapy
Regeneron and Sanofi disclosed on Wednesday the outcomes of Phase 3 trials for Dupixent, a prominent asthma treatment. The results brought a blend of triumph and tribulation to the pharmaceutical giants.
Victory in the Battle Against Bullous Pemphigoid
The interleukin-targeting monoclonal antibody Dupixent emerged victorious in a Phase 3 trial aimed at treating bullous pemphigoid, a severe skin ailment marked by agonizing itch and blistering. The trial, comprising 106 subjects, surpassed expectations by meeting primary and secondary endpoints for adults grappling with moderate-to-severe bullous pemphigoid.
One key highlight from the trial was the impressive remission rate observed. A staggering 20% of participants on Dupixent experienced sustained disease remission at 36 weeks, in stark contrast to a mere 4% on the placebo. Additionally, secondary measures like a drastic reduction in disease severity and notable itch relief exhibited statistically significant results.
Navigating the Safety Territory
When it comes to safety, the data revealed that 96% of subjects on Dupixent encountered adverse effects, a figure mirrored in the placebo group. Notably, there were no fatalities linked to adverse events in the Dupixent cohort, while unfortunate outcomes from two adverse events were recorded in the placebo arm.
The Road Ahead for Dupixent in Chronic Pruritus
Besides the triumph in bullous pemphigoid, Regeneron and Sanofi provided insights into the Phase 3 journey of Dupixent in chronic pruritus of unknown origin (CPUO). The program involves Study A and Study B, each having its trials at late stages.
While the preliminary results from the smaller Study A for adults struggling with severe CPUO fell short of statistical superiority in the primary itch responder endpoint, Study B is anticipated to kick start as a subsequent pivotal trial. Nevertheless, Dupixent displayed a safety profile consistent with its existing safety record in Study A.
