New Drug Proves to Ease the Itch for Chronic Spontaneous Urticaria
Topline results from a late-stage trial announced Thursday show Regeneron Pharmaceuticals and Sanofi's Dupixent (dupilumab) significantly reduced itch and hives better than antihistamines alone in biologic-naiïve patients with moderate-to-severe chronic spontaneous urticaria.
The 24-week study enrolled 138 patients with inflammatory skin disease and compared Dupixent with standard-of-care alone in terms of itch severity and urticaria activity (hives and itch). At 24 weeks, the active therapy group had a 63% reduction in itch severity compared with 35% in the placebo group (10.24- vs. 6.01-point reductions, respectively; p<0.001).
Additionally, those who received Dupixent had a 65% reduction in urticaria activity severity, while only 37% of patients who received standard of care alone had such reduction (20.53- vs. 12.00-point reduction, respectively; p<0.001). Safety was similar to the therapy’s known profile in its currently approved indications. No difference was found between the active therapy group and the control group in regard to the incidence of treatment emergent adverse events (50% vs. 59%).
John Reed, M.D., Ph.D., Sanofi’s Global Head of Research and Development, said in a statement that the chronic nature of chronic spontaneous urticaria exerts an emotional and physical burden on patients who do not have the condition adequately controlled.
“This is the fifth inflammatory disease in which Dupixent has demonstrated a significant improvement in symptoms and disease manifestations in Phase III pivotal studies,” added Dr. Reed. “The success of this trial underscores the agility of our clinical operations team considering the pandemic conditions and underscores our ability to deliver on an aggressive timeline for addressing a significant unmet need for this patient population.”
Regeneron’s president and chief scientific officer, George D. Yancopoulos, M.D., Ph.D., stated that this most recent study represents the first late-stage trial to demonstrate that Dupixent’s action of targeting of IL-4 and IL-13 can address debilitating symptoms of the condition better than standard-of-care antihistamines.
“These data add to the increasing body of evidence that using Dupixent can reduce the disease burden of a diverse range of dermatologic, respiratory and gastrointestinal diseases,” explained Dr. Yancopoulos. “By early 2022, we look forward to reporting results from a second trial in patients who were unable to control their chronic spontaneous urticaria with another biologic medicine, as well other trial results in additional dermatologic diseases.”
AstraZeneca, who was developing rival atopic dermatitis drug tezepelumab, recently removed its candidate from the company’s clinical development pipeline. This move follows the news that its partner, Amgen, had discontinued a Phase II trial last year in atopic dermatitis due to the therapy’s disappointing efficacy.
In addition to its research efforts on Dupixent with Sanofi, Regeneron is concurrently in the works with AstraZeneca to research, develop and commercialize novel small molecules for obesity. These small molecules will target GPR75 to address obesity and its associated comorbidities. The new collaboration between Regeneron and AstraZeneca follows recent research showing that rare genetic mutations in the GPR75 gene are associated with protection from obesity.