Immunovant Announces Positive Results for Batoclimab Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Studies
Immunovant (IMVT) has announced positive results from its clinical trials for batoclimab in two autoimmune conditions. The Phase 3 study in Myasthenia Gravis (MG) achieved its primary endpoint, demonstrating significant improvements in MG-ADL scores: a 5.6-point improvement in the higher dose arm (74% IgG reduction) and a 4.7-point improvement in the lower dose arm (64% IgG reduction).
In the Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 2b study's Period 1, patients showed a mean improvement of 1.8 in adjusted INCAT disability scores. Notably, an 84% responder rate was observed in patients achieving over 70% IgG reduction. Both studies confirmed that deeper IgG reductions correlated with better clinical outcomes.
The company has active INDs for both conditions and plans to initiate pivotal studies for their lead asset IMVT-1402 in these indications.
Immunovant (IMVT) ha annunciato risultati positivi dai suoi studi clinici per il batoclimab in due condizioni autoimmuni. Lo studio di Fase 3 in Miastenia Grave (MG) ha raggiunto il suo obiettivo primario, dimostrando miglioramenti significativi nei punteggi MG-ADL: un miglioramento di 5,6 punti nel braccio con dose più alta (riduzione del 74% di IgG) e un miglioramento di 4,7 punti nel braccio con dose più bassa (riduzione del 64% di IgG).
Nello studio di Fase 2b sulla Neuropatia Demielinizzante Infiammatoria Cronica (CIDP), nel Periodo 1, i pazienti hanno mostrato un miglioramento medio di 1,8 nei punteggi di disabilità INCAT corretti. È stato osservato un tasso di risposta dell'84% nei pazienti che hanno raggiunto oltre il 70% di riduzione di IgG. Entrambi gli studi hanno confermato che riduzioni più profonde di IgG correlano con migliori risultati clinici.
L'azienda ha IND attivi per entrambe le condizioni e prevede di avviare studi pivotal per il suo principale asset IMVT-1402 in queste indicazioni.
Immunovant (IMVT) ha anunciado resultados positivos de sus ensayos clínicos para el batoclimab en dos condiciones autoinmunes. El estudio de Fase 3 en Miastenia Gravis (MG) alcanzó su objetivo primario, demostrando mejoras significativas en las puntuaciones de MG-ADL: una mejora de 5.6 puntos en el grupo de dosis alta (reducción del 74% de IgG) y una mejora de 4.7 puntos en el grupo de dosis baja (reducción del 64% de IgG).
En el estudio de Fase 2b sobre Neuropatía Desmielinizante Inflamatoria Crónica (CIDP), en el Período 1, los pacientes mostraron una mejora media de 1.8 en las puntuaciones de discapacidad ajustadas de INCAT. Notablemente, se observó una tasa de respuesta del 84% en pacientes que lograron más del 70% de reducción de IgG. Ambos estudios confirmaron que reducciones más profundas de IgG se correlacionan con mejores resultados clínicos.
La empresa tiene IND activos para ambas condiciones y planea iniciar estudios pivotal para su activo principal IMVT-1402 en estas indicaciones.
Immunovant (IMVT)는 두 가지 자가면역 질환에 대한 batoclimab의 임상 시험에서 긍정적인 결과를 발표했습니다. 중증 근무력증 (MG)에 대한 3상 연구는 주요 목표를 달성하며 MG-ADL 점수에서 유의미한 개선을 보여주었습니다: 고용량 그룹에서 5.6점 개선(74% IgG 감소)과 저용량 그룹에서 4.7점 개선(64% IgG 감소)을 기록했습니다.
만성 염증성 탈수초 다발신경병증 (CIDP)에 대한 2b상 연구의 1기에서, 환자들은 조정된 INCAT 장애 점수에서 평균 1.8의 개선을 보였습니다. 특히, 70% 이상의 IgG 감소를 달성한 환자에서 84%의 반응률이 관찰되었습니다. 두 연구 모두 IgG의 더 깊은 감소가 더 나은 임상 결과와 상관관계가 있음을 확인했습니다.
회사는 두 조건에 대한 활성 IND를 보유하고 있으며, 이러한 적응증에 대해 주요 자산인 IMVT-1402에 대한 중대한 연구를 시작할 계획입니다.
Immunovant (IMVT) a annoncé des résultats positifs de ses essais cliniques pour le batoclimab dans deux conditions auto-immunes. L'étude de Phase 3 sur la Myasthénie Grave (MG) a atteint son objectif principal, montrant des améliorations significatives des scores MG-ADL : une amélioration de 5,6 points dans le groupe à dose élevée (réduction de 74 % d'IgG) et une amélioration de 4,7 points dans le groupe à dose faible (réduction de 64 % d'IgG).
Dans l'étude de Phase 2b sur la Neuropathie Démyélinisante Inflammatoire Chronique (CIDP), au Période 1, les patients ont montré une amélioration moyenne de 1,8 dans les scores de handicap INCAT ajustés. Notamment, un taux de réponse de 84 % a été observé chez les patients atteignant plus de 70 % de réduction d'IgG. Les deux études ont confirmé que des réductions plus profondes d'IgG étaient corrélées à de meilleurs résultats cliniques.
L'entreprise a des IND actifs pour les deux conditions et prévoit de lancer des études pivot pour son actif principal IMVT-1402 dans ces indications.
Immunovant (IMVT) hat positive Ergebnisse aus seinen klinischen Studien zu Batoclimab bei zwei Autoimmunerkrankungen bekannt gegeben. Die Phase-3-Studie bei Myasthenia Gravis (MG) erreichte ihr primäres Ziel und zeigte signifikante Verbesserungen der MG-ADL-Werte: eine Verbesserung um 5,6 Punkte in der Hochdosisgruppe (74% IgG-Reduktion) und eine Verbesserung um 4,7 Punkte in der Niedrigdosisgruppe (64% IgG-Reduktion).
In der Phase-2b-Studie zur Chronischen Entzündlichen Demyelinisierenden Polyneuropathie (CIDP) zeigten die Patienten im Zeitraum 1 eine durchschnittliche Verbesserung von 1,8 in den angepassten INCAT-Behinderungswerten. Bemerkenswerterweise wurde eine Ansprechrate von 84% bei Patienten beobachtet, die mehr als 70% IgG-Reduktion erreichten. Beide Studien bestätigten, dass tiefere IgG-Reduktionen mit besseren klinischen Ergebnissen korrelieren.
Das Unternehmen hat aktive INDs für beide Erkrankungen und plant, entscheidende Studien für seinen Hauptbestandteil IMVT-1402 in diesen Indikationen zu starten.
- Phase 3 MG trial met primary endpoint with significant clinical improvements
- Strong efficacy demonstrated in CIDP study with 84% responder rate
- Clear correlation between IgG reduction and clinical benefits established
- Active INDs and imminent pivotal studies for lead asset IMVT-1402
- None.
Insights
Immunovant announced positive Phase 3 results for batoclimab in Myasthenia Gravis (MG) and positive Phase 2b results in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), representing significant clinical milestones for the company's FcRn inhibitor platform.
The MG Phase 3 study met its primary endpoint with impressive clinical improvements: the higher dose arm demonstrated a
In the CIDP study, following standard-of-care washout, patients showed a mean improvement of 1.8 points in INCAT disability score with an impressive
A Clinical Biomarker Specialist: "The consistent correlation between IgG reduction and clinical outcomes across multiple endpoints validates the mechanistic approach of FcRn inhibition in antibody-mediated autoimmune diseases. The dose-dependent response seen in both indications provides compelling evidence that deeper IgG suppression translates to enhanced clinical benefit, which could differentiate Immunovant's approach in the growing FcRn inhibitor space."
A Neurological Disease Expert: "These results in two distinct neurological autoimmune conditions significantly strengthen Immunovant's clinical platform. While currently approved FcRn inhibitors have shown efficacy, these data suggest that optimizing the degree of IgG reduction may provide additional benefit for patients with inadequate responses to existing therapies. The company's advancement timeline for their lead asset IMVT-1402, with INDs already active and pivotal studies described as 'imminent,' indicates potential acceleration of their clinical development program. The success in both MG and CIDP suggests their approach may be applicable across multiple antibody-mediated conditions, substantially expanding their potential therapeutic reach."
- Pivotal study in MG met primary endpoint of change from baseline in MG-ADL in AChR+ population at 12 weeks, with a 5.6 point improvement in the higher dose arm (with
74% mean IgG reduction) and a 4.7 point improvement in the lower dose arm (with64% mean IgG reduction) - Initial CIDP results from Period 1, following standard of care washout, demonstrate a mean improvement in the adjusted INCAT disability score of 1.8 across batoclimab arms and an
84% responder rate in those patients who achieved an IgG lowering greater than70% - In both batoclimab studies, deeper IgG reductions correlated with better clinical outcomes across a range of assessments and timepoints
- INDs active for both MG and CIDP with pivotal study initiations for lead asset IMVT-1402 in these indications expected imminently
- Immunovant and Roivant to host combined investor call to discuss these updates today, March 19, 2025 at 8 a.m. EDT
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.
“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 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. 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 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.
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. 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 3 MG Study Results Highlights
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. 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:
| Snapshot of Efficacy Measures Observed (% AChR+ Population) | Placebo | Batoclimab 340mg (QW)^ | Batoclimab 680mg (QW)^^ |
| Minimal Symptom Expression (MSE*) at Wk 12 | |||
| Durable MSE** | |||
| Early Super Responders (≥5 point reduction in MG-ADL score by Wk 2) | |||
| Early Super Responders (≥6 point reduction in MG-ADL score by Wk 2) | |||
| Early Super Responders (≥7 point reduction in MG-ADL score by Wk 2) | |||
| ^ all p<0.05 except early super responders ≥7 where p=0.07; | |||
| ^^ all p<=0.001 | |||
| * MSE defined as patients that achieved an MG-ADL score of 0 or 1 at Week 12 | |||
| ** Durable MSE defined as patients maintaining MSE for >6 weeks, amongst those that achieved MSE prior to or by Week 6 | |||
Safety and tolerability were observed to be consistent with prior batoclimab studies.
Phase 2b CIDP Study Results Highlights
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
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 3 studies of batoclimab in thyroid eye disease are available.
Webcast Details
The company will host an investor call and webcast with Immunovant CEO Dr. Pete Salzmann, M.D., MBA and Roivant CEO Matt Gline at 8:00 a.m. EDT today, March 19, 2025 to discuss these updates. Please click here to register for the event. The live webcast will also be available under the News & Events section of Immunovant’s website and the Events & Presentations section of Roivant’s website. A replay of the event and presentation will be available immediately following the event.
About Immunovant, Inc.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "can," “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” "intend," and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include Immunovant’s expectations relating to the results of its batoclimab clinical trials; Immunovant's plan to develop IMVT-1402 in MG and CIDP; and the potential benefits of IMVT-1402 and its potential best-in-class profile. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the timing of the commencement of additional clinical trials; Immunovant’s scientific approach, clinical trial design, indication selection, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of global factors, geopolitical tensions, and adverse macroeconomic conditions on Immunovant’s business operations and supply chain, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval and commercialization of IMVT-1402 and batoclimab; Immunovant is at an early stage of development for IMVT-1402 and in various stages of clinical development for batoclimab; and Immunovant will require additional capital to fund its operations and advance batoclimab and IMVT-1402 through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s Form 10-Q filed with the SEC on February 6, 2025, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.
Immunovant Investor Contact:
Renee Barnett, MBA
Chief Financial Officer
Immunovant, Inc.
info@immunovant.com
FAQ
What were the key results of IMVT's Phase 3 batoclimab trial in Myasthenia Gravis?
How effective was batoclimab in the CIDP Phase 2b study?
What is the correlation between IgG reduction and clinical outcomes in IMVT's studies?
What are Immunovant's next steps for IMVT-1402 in MG and CIDP?
