Immunovant Announces Positive Topline Results from Multi-Center, Placebo-Controlled Phase 2a Trial of IMVT-1401, A Novel Investigational Anti-FcRn Antibody Delivered by Subcutaneous Injection, in Myasthenia Gravis

Company to Host Conference Call on August 25, 2020 at 8:30am EDT

• 3.8-point mean improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale was statistically significant vs. placebo (p = 0.029)
• 8.0-point mean improvement on Myasthenia Gravis Composite (MGC) scale was highly statistically significant vs. placebo (p = 0.006)
• Mean reductions in total IgG from baseline for the 340 mg and 680 mg cohorts were 59% and 76%, respectively
• IMVT-1401 was observed to be generally safe and well-tolerated with no serious adverse events (SAEs) and no withdrawals due to adverse events (AEs)
• Registration-enabling Phase 3 MG trial is expected to initiate in the first half of 2021

NEW YORK, Aug. 25, 2020 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases, today announced positive topline results from ASCEND MG, a Phase 2a study of IMVT-1401 in patients with myasthenia gravis (MG).

The multi-center, randomized, placebo-controlled trial was designed to evaluate the safety, tolerability, pharmacodynamics, and efficacy of IMVT-1401 in patients with moderate-to-severe generalized MG. Results from the six-week treatment period included three arms: 340 mg IMVT-1401 weekly (N=5), 680 mg IMVT-1401 weekly (N=5), and placebo (N=5).

As evaluated in a pre-specified, pooled analysis of 15 patients who completed Day 42, IMVT-1401-treated patients (N=10) showed a mean 3.8-point improvement on the MG-ADL scale vs. a mean decline of +0.6 for placebo, a result that was statistically significant (p = 0.029). IMVT-1401-treated patients also showed a highly statistically significant improvement on the MGC scale, with an average improvement of 8.0 points vs. a mean decline of +1.4 for placebo (p = 0.006).

MG-ADL responder rates, defined as the percentage of patients showing a > 2-point improvement, were 60% for IMVT-1401-treated patients vs. 20% for placebo. MG-ADL deep responder rates, defined in the study as the percentage of patients showing a > 6-point improvement, were 40% for IMVT-1401-treated patients vs. 0% for placebo.  MGC deep responder rates, defined in the study as the percentage of patients showing a > 10-point improvement, were 40% for IMVT-1401-treated patients vs. 0% for placebo.