The LIBERTY-CUPID pivotal program was initiated in 2020 with an accelerated direct-to-Phase 3 strategy. The previously reported Phase 3 trial, which evaluated a different group of patients who were biologic-naïve, met its primary and all key secondary endpoints at 24 weeks showing that adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives compared to antihistamines alone.
"The companies remain committed to advancing Dupixent for patients with CSU uncontrolled on antihistamines and are evaluating next steps," the release stated.
John Reed, M.D., Ph.D. Executive Vice President, Global Head of Research and Development at Sanofi "Although we are disappointed in these latest results, this interim analysis contributes to furthering our understanding of the role of type 2 inflammation in this subset of CSU patients who are refractory to all other approved therapies. Based on the results seen in our first Phase 3 trial, and the numerical trends observed in this interim analysis, we remain committed to advancing Dupixent as an option for patients suffering from CSU who are uncontrolled on antihistamines. We look forward to discussing next steps with regulators."
Detailed results from the first trial will be presented at the AAAAI Annual Meeting later this month and the companies expect to share results from the second trial in a scientific forum.
The companies also recently announced positive Phase 3 results in eosinophilic esophagitis (EoE) and prurigo nodularis (PN), and additional results are also expected later this year in pediatric EoE, chronic inducible urticaria-cold (CindU), and hand and foot atopic dermatitis.
The potential use of Dupixent in CSU, EoE, PN, CindU and hand and foot atopic dermatitis are currently under clinical development and the safety and efficacy have not been fully evaluated by any regulatory authority.
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