Immunovant, Inc. announced initial data from 600 mg MAD cohort of a Phase 1 clinical trial of IMVT-1402 in healthy adults. The results show that four subcutaneously administered doses of 600 mg produced a mean IgG reduction similar to high dose batoclimab, but with minimal changes in albumin and LDL-C similar to those in placebo, confirming the potential of IMVT-1402 as a best-in-class neonatal fragment crystallizable receptor (FcRn) inhibitor. The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMVT-1402 in healthy adults.

Four once-weekly SC injections of 600 mg IMVT-1402 reduced total IgG level by a mean of 74%, a potency that is similar to batoclimab at 680 mg that reduced IgG by 76% after 4 weekly doses. In disease settings where batoclimab was administered continuously, a reduction of 80% was observed at steady state after about 6-8 weeks. Company believe steady state IgG reduction with IMVT-1402 will match this result and timing.

Across all doses evaluated, treatments with IMVT-1402 were generally well tolerated with only mild or moderate treatment-emergent adverse events observed. Serum albumin and LDL-C at Day 29 (peak pharmacodynamic impact) did not show a significant decrease or increase, respectively, from baseline (p-values > 0.05).