TYK2 inhibitor miss pushes Alumis toward precision strategy for lupus
Subgroup signal suggests IFN enrichment could rescue envudeucitinib’s Phase II all-comers miss — a strategy lupus trials have pursued in the past
Despite a Phase IIb miss in SLE all-comers that sent Alumis shares falling on Tuesday, the company believes that a robust response in the interferon-high prespecified subgroup for the TYK2 inhibitor is enough signal to overcome the all-comers noise and support a Phase III trial. Patient stratification could save the program, but Alumis hasn’t determined whether to restrict enrollment in Phase III.
Despite strong biological rationale, systemic lupus erythematosus (SLE) therapies have been held back by difficulties in clinical trial design, primarily a high placebo effect and inconsistencies in standard of care. In a top-line readout on Tuesday, Alumis Inc. (NASDAQ:ALMS) announced that its oral TYK2 inhibitor envudeucitinib did not meet its primary and secondary endpoints at 48 weeks in the 408-patient Phase IIb LUMUS trial for moderate-to-severe SLE...