Immunovant’s IMVT-1402 shows Phase 1 efficacy

Immunovant announced that subcutaneously administered doses of IMVT-1402 produced dose-dependent reductions in IgG in initial data from a Phase 1 clinical trial in healthy adults, with no dose-related changes in serum albumin or LDL-C, bolstering IMVT-1402 as a potential best-in-class neonatal fragment crystallizable receptor inhibitor. In the single-ascending dose portion of the study, subcutaneously administered IMVT-1402 demonstrated a consistent reduction in IgG with potency that was similar to or greater than that of batoclimab. The safety data were generally favorable, with all adverse events (AEs) mild or moderate, and no significant reduction from baseline in serum albumin or increase in LDL-C observed at any timepoint measured. Initial MAD study results for the 300 mg cohort were released. After four weekly 300 mg SC doses of IMVT-1402, the mean total IgG reduction from baseline in this MAD cohort was 63%, with no decrease in serum albumin below baseline and no increase in LDL-C above baseline observed. Treatment-emergent adverse events were observed to be mild or moderate in severity. IMVT-1402 was delivered subcutaneously in seconds to participants in this cohort as a simple 2 mL injection at a concentration of 150 mg/mL.