Alumis said it plans to pursue a Phase III lupus program for envudeucitinib despite the Phase IIb LUMUS trial missing its primary and key secondary endpoints in the overall population.
The 408-patient trial evaluated adults with moderate-to-severe systemic lupus erythematosus over 48 weeks. The primary endpoint was the BICLA measure of disease improvement.
The company highlighted a prespecified subgroup with a high interferon gene signature, or IFNGS-high, that showed robust responses on the primary and secondary measures. Alumis may restrict future enrollment to this biomarker-defined group or limit IFNGS-low patients.
Alumis plans End-of-Phase II discussions with the FDA and EMA to determine the Phase III design, enrollment criteria, dose, and trial size. Progression is therefore not yet guaranteed and depends on regulatory feedback.
No new safety signals were reported. Alumis shares fell sharply after the announcement, reflecting investor concern over the overall trial failure.
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