NEW YORK, March 19, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported topline results from its Phase 3 study of batoclimab in MG and initial results from Period 1 of its Phase 2b study in CIDP..

纽约，2025年3月19日（GLOBE NEWSWIRE）-- Immunovant, Inc.（纳斯达克股票代码：IMVT），一家致力于为自身免疫性疾病患者提供正常生活的临床阶段免疫学公司，今天报告了其在重症肌无力（MG）中进行的batoclimab III期研究的初步结果，以及其在慢性炎性脱髓鞘多发性神经病（CIDP）中进行的IIb期研究第一阶段的初步结果。

“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.

“我们很高兴分享MG和CIDP研究的积极结果。虽然神经科医生和患者对目前获批的FcRn抑制剂非常热情，但他们告诉我们，他们也看到下一代FcRn抑制剂的巨大潜力，它可以为那些疾病仍在影响日常功能的患者提供更深入、更持久的反应。

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..

今天的试验结果表明，更深度的 IgG 降低会带来 MG 和 CIDP 更好的治疗效果。除了 MG 和 CIDP 的结果之外，我们相信我们的核心论点——即通过高剂量 batoclimab 和高剂量 IMVT-1402 实现的更深度 IgG 降低能够改善临床结果——将适用于广泛的自身抗体介导的疾病，

About the Phase 3 Study in MG

关于MG的第3阶段研究

The Phase 3 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.

重症肌无力（MG）的 III 期研究是一项随机、四盲、安慰剂对照的研究，旨在评估巴托利单抗在成人 MG 患者中的疗效和安全性。经过筛选后，中重度 MG 参与者被随机分配至第 1 阶段，接受高剂量巴托利单抗（每周 680 毫克）、低剂量巴托利单抗（每周 340 毫克）或安慰剂治疗，持续 12 周。

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)..

第1阶段对巴托利单抗有反应的患者定义为与基线相比，重症肌无力日常生活活动（MG-ADL）评分改善≥2分，这些患者被重新随机分配为1:1:1三组，分别接受每周340mg或每两周340mg的巴托利单抗或安慰剂治疗，持续12周（第2阶段）。研究的主要终点是乙酰胆碱受体抗体阳性（AChR+）参与者在第12周（第1阶段结束时）MG-ADL评分较基线的平均变化。

About the Phase 2b Study in CIDP

关于CIDP的2b期研究

The Phase 2b 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.

CIDP的2b期研究是一项随机、四盲、安慰剂对照的研究，旨在评估batoclimab在患有活动性CIDP的成年参与者中的有效性和安全性。

Similar to other recent studies, this Phase 2b 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.

与最近的其他研究类似，这项CIDP的2b期研究开始时为非安慰剂对照的导入期（第1阶段），在此期间，疾病在标准治疗清除期间恶化的参与者随后每周通过皮下注射接受340毫克或680毫克的巴托利单抗。

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).

在第一阶段（第1期）对巴托利单抗治疗有反应的参与者（反应者定义为调整后的炎症性神经病病因和治疗（aINCAT）残疾评分从第1期基线改善≥1分的患者），随后将以1:1的比例随机分配，在24周的停药期（第2期）中每周接受340毫克巴托利单抗或安慰剂。

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..

主要终点将评估在第36周（即第2阶段结束时）无复发的参与者百分比。研究正在进行中，尚未揭盲。因此，目前可获得第1阶段的汇总数据，而第2阶段结束时的主要终点数据尚不可用。

Phase 3 MG Study Results Highlights

第三阶段MG研究结果亮点

In the Phase 3 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.

在3期MG研究中，巴托利单抗在AChR+参与者中达到了主要终点，即MG-ADL基线的平均变化。进入研究并随机分配至每周通过皮下注射给予680mg巴托利单抗的参与者，在第12周时MG-ADL改善了5.6分；而随机分配至每周通过皮下注射给予340mg巴托利单抗的参与者，在第12周时MG-ADL改善了4.7分；而接受安慰剂的参与者在第12周时MG-ADL改善了3.6分。

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. Additional efficacy results are summarized in the table below:.

观察到剂量组之间的差异很大，尤其是对于更深的反应阈值。第2阶段（第12-24周）的结果符合预期，重新随机分配至每周340mg剂量的患者表现优于那些剂量减少的患者。其他疗效结果总结在下表中：

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

安全性与耐受性观察结果与之前的巴托利单抗研究一致。

Phase 2b CIDP Study Results Highlights

第2b阶段CIDP研究结果亮点

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%.

在2b期CIDP研究的第1阶段运行期内，汇集所有队列中的73名患者的初步batoclimab数据显示，aINCAT评分在第12周相比第一阶段基线改善了1.8分。在所有IgG减少≥70%的患者中，观察到84%的应答率（应答定义为aINCAT改善≥1）。

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..

其他CIDP量表也显示出对汇总的巴托利单抗队列有显著改善，12周时I-RODS改善15.3，MRC-SS改善5.6，握力改善15.1。

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

安全性与耐受性观察结果与之前的巴托利单抗研究一致。

Path Forward in MG and CIDP

MG和CIDP的前进路径

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.

Immunovant计划通过其主导资产IMVT-1402在重症肌无力（MG）和慢性炎性脱髓鞘性多发性神经病（CIDP）中启动可能具有注册意义的研究，并已获得针对这两种适应症的新药临床试验申请（IND）批准，正如之前所披露的。尽管迄今为止，抗FcRn类药物对MG和CIDP患者带来了显著改善，但仍然存在显著的未满足需求。

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..

IMVT-1402 是一种潜在的同类最优抗 FcRn，可为 MG、CIDP 和许多其他具有挑战性的自身免疫疾病患者提供更深入、更持久的临床反应。

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 3 studies of batoclimab in thyroid eye disease are available..

目前，Immunovant并不打算寻求batoclimab在重症肌无力（MG）或慢性炎性脱髓鞘多发性神经病（CIDP）方面的监管批准，而是专注于利用batoclimab研究的数据和经验来指导并加速其IMVT-1402项目。Immunovant将等到正在进行的batoclimab治疗甲状腺眼病的III期研究结果出来后，再对batoclimab的监管提交做出最终决定。