Batoclimab Phase III Results

(Chronic Inflammatory Demyelinating Polyneuropathy ).

“We are excited to share positive results from our MG and CIDP studies. While neurologists and patients are very enthusiastic about currently approved FcRn inhibitors, they tell us that they also see a lot of potential for a next-generation FcRn inhibitor that can offer deeper and more durable responses for patients whose disease is still affecting their daily function. Today’s results show that deeper IgG reduction leads to deeper responses in MG and CIDP. Beyond the results in MG and CIDP, we believe that our core thesis - that deeper IgG reduction, at the levels achieved by high dose batoclimab and high dose IMVT-1402, leads to improved clinical outcomes - will apply to a wide range of auto-antibody mediated conditions,” said Pete Salzmann, M.D., chief executive officer of Immunovant.

About the Phase 3 Study in MG; The Phase III study in MG is a randomized, quadruple-blind, placebo-controlled study designed to assess the efficacy and safety of batoclimab in adults with MG. Following screening, participants with moderate to severe MG were randomized into Period 1 where they received high dose batoclimab (680mg weekly) or lower dose batoclimab (340mg weekly) or placebo for 12 weeks. Responders to batoclimab in Period 1, defined as ≥2-point improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline, were re-randomized 1:1:1 to batoclimab (340mg weekly or 340mg every other week) or placebo for 12 weeks (Period 2). The primary endpoint of the study was mean change from baseline in MG-ADL in acetylcholine receptor antibody positive (AChR+) participants at Week 12 (end of Period 1).

About the Phase 2b Study in CIDP; The Phase IIb study in CIDP is a randomized, quadruple-blind, placebo-controlled study designed to assess the efficacy and safety of batoclimab in adult participants with active CIDP. Similar to other recent studies, this Phase IIb study in CIDP begins with a non-placebo controlled run-in (Period 1), during which participants whose disease had worsened during standard of care washout then receive either 340 mg or 680 mg batoclimab weekly by subcutaneous injection. Participants who respond to batoclimab therapy in Period 1 (responders are defined as those achieving a ≥1 point improvement from Period 1 baseline in adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT) disability score), are then randomized 1:1 to receive either 340 mg batoclimab or placebo weekly in a 24-week withdrawal period (Period 2). The primary endpoint will assess the percentage of participants who remain relapse-free at Week 36, at the end of Period 2. The study is ongoing and has not yet been unblinded. Therefore, pooled data are currently available from Period 1 and no data are available for the primary endpoint at the end of Period 2.

Phase III MG Study Results Highlights: In the Phase III MG study, batoclimab met its primary endpoint of mean change from baseline in MG-ADL in AChR+ participants. Participants entering the study and randomized to 680mg of batoclimab given weekly by subcutaneous injection achieved a 5.6 point improvement in MG-ADL at Week 12, while those randomized to 340mg of batoclimab given weekly by subcutaneous injection achieved a 4.7 point improvement in MG-ADL at Week 12 and those randomized to placebo experienced a 3.6 point improvement in MG-ADL at Week 12. Large differences between the dosing arms were observed, especially for deeper response thresholds. Results in Period 2 (Weeks 12-24) were as expected, with patients re-randomized to 340mg weekly outperforming those whose dose was reduced.

Phase IIb CIDP Study Results Highlights; Initial batoclimab data in 73 patients pooled across all cohorts for the run-in Period 1 of the Phase IIb 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 all at Week 12. Safety and tolerability were observed to be consistent with prior batoclimab studies.

Path Forward in MG and CIDP: Immunovant plans to initiate potentially registrational studies in both MG and CIDP with lead asset IMVT-1402 and has received clearance for its Investigational New Drug (IND) applications for both indications as previously disclosed. Despite meaningful improvement for patients with MG and CIDP to date with the anti-FcRn class, there continues to be significant unmet need. IMVT-1402 is a potentially best-in-class anti-FcRn that may deliver deeper and more durable clinical responses for patients with MG, CIDP, and many other challenging autoimmune conditions.

At present, 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 inform and accelerate its programs with IMVT 1402. Immunovant will wait to make a final decision about regulatory submissions for batoclimab until the results of the ongoing Phase III studies of batoclimab in thyroid eye disease are available.