Sanofi SA (SNY) on Friday reported positive results from two additional global phase 3 trials—SHORE and COAST-2 — for amlitelimab for the treatment of patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD).
The company had previously reported positive results from COAST-1 phase 3 study of amlitelimab in AD.
In the SHORE phase 3 study, amlitelimab in combination with topical therapies met all primary and key secondary endpoints at Week 24, with efficacy increasing throughout the treatment period. Some patients showed clinical improvement as early as Week 2.
In the COAST-2 phase 3 study, amlitelimab demonstrated statistically significant efficacy on vIGA-AD 0/1, a measure of atopic dermatitis severity, which served as the primary endpoint for the U.S. and U.S. reference countries. However, the drug did not achieve statistical significance for the co-primary endpoints in the EU and EU reference countries.
Based on these data, the company said it plans to move ahead with global regulatory submissions for amlitelimab.
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