Regeneron-Sanofi stopping phase 3 trial of Dupixent to treat hives due to futility
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Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) are stopping a phase 3 trial (CUPID STUDY B) of Dupixent (dupilumab) in patients with chronic spontaneous urticaria (CSU) due to futility following an interim analysis.
CSU a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin and/or swelling deep under the skin.
The trial, which evaluated Dupixent added to antihistamines in patients refractory to omalizumab at 24 weeks, showed positive trends in reducing itch and hives (the main goals) but did not meet statistical significance.
The companies said the safety data were generally consistent with the known safety profile of Dupixent in its approved indications.
A previous phase 3 trial, which evaluated a different group of patients who were not previously treated with omalizumab, met its primary and all key secondary goals at 24 weeks, showing that adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives compared to antihistamines alone.
"While Dupixent did not show a significant benefit in the most difficult-to-treat patients who remain refractory to all approved medicines, we are carefully assessing the potential role of Dupixent in CSU based on the success of the first Phase 3 trial in biologic-naÃ¯ve patients, where Dupixent nearly doubled the reduction in itch and urticaria activity," said Regeneron's (REGN) President and Chief Scientific Officer George Yancopoulos.
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