Immunovant Announces Positive IMVT-1402 Initial 600 mg MAD Results that Confirm Best-in-Class Potential

• Results from the 600 mg MAD cohort for IMVT-1402 similar to previously disclosed results from the 300 mg MAD cohort for IMVT-1402
  
• IMVT-1402 was observed to deliver dose dependent and deep IgG reductions similar to batoclimab in its Phase 1 study
• IMVT-1402 600 mg was observed to deliver placebo-like impact on albumin and low-density lipoprotein cholesterol (LDL-C), similar to the previously disclosed 300 mg MAD cohort data
• Potential best-in-class profile enables broad and exciting portfolio of indications, taking advantage of IgG reduction we expect will reach 80% with continued weekly dosing of 600 mg delivered by simple subcutaneous injection

NEW YORK, Nov. 28, 2023 (GLOBE NEWSWIRE) --  Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today 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.

“We are energized by this potential best-in-class profile, which opens the door to a unique portfolio of first-in-class and best-in-class indications for IMVT-1402, with an emphasis on those indications where potency matters most,” said Pete Salzmann, M.D., chief executive officer at Immunovant. “FcRn inhibition is a proven mechanism with broad applicability, and we believe that a growing body of evidence supports a consistent correlation between deeper IgG reduction and greater efficacy. This translates to the potential to build a class-leading anti-FcRn franchise with IMVT-1402.”

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. We believe steady state IgG reduction with IMVT-1402 will match this result and timing.