Immunovant Ditches Seeking FDA Approval For Batoclimab For Two Autoimmune Disorders Despite Positive Phase 3 Data

Wednesday, Immunovant, Inc. IMVT released topline results from its Phase 3 study of batoclimab in myasthenia gravis (MG) and initial results from Period 1 of its Phase 2b study in chronic inflammatory demyelinating polyneuropathy (CIDP).

Immunovant is a member of the Roivant Sciences Ltd. ROIV family of companies.

In the Phase 3 MG study, batoclimab met its primary endpoint of mean change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in acetylcholine receptor antibody positive (AChR+) participants.

Participants entering the study and randomized to 680mg of batoclimab given weekly by subcutaneous injection achieved a 5.6-point improvement (with 74% mean IgG reduction) in MG-ADL at Week 12.
In comparison, those randomized to 340mg of batoclimab given weekly by subcutaneous injection achieved a 4.7-point improvement (with 64% mean IgG reduction).
Those randomized to placebo experienced a 3.6-point improvement in MG-ADL at Week 12.

Initial batoclimab data in 73 patients pooled across all cohorts for the run-in Period 1 of the Phase 2b CIDP study demonstrated a 1.8 point improvement in aINCAT (compared to Period 1 baseline) at Week 12.

An 84% responder rate (with response defined as an aINCAT improvement ≥ 1) was observed among all patients whose IgG was reduced by ≥ 70%.
Other CIDP scales also demonstrated meaningful improvements for pooled batoclimab cohorts, with an improvement in I-RODS of 15.3, an improvement in MRC-SS of 5.6, and an improvement in grip strength of 15.1.

Safety and tolerability were observed to be consistent with prior batoclimab studies.

Immunovant does not intend to seek regulatory approval for batoclimab in MG or CIDP and is focused on leveraging data and learnings from the batoclimab studies to accelerate programs with IMVT-1402.

Immunovant plans to initiate potentially registrational studies in MG and CIDP with lead asset IMVT-1402 and has received clearance for its Investigational New Drug applications.

Immunovant will wait to decide on regulatory submissions for batoclimab until the results of the ongoing Phase 3 studies of batoclimab in thyroid eye disease are available.

Price Action: IMVT stock is down 0.40% at $18.72 at the last check Wednesday.

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