Roivant Announces Positive Results for Batoclimab Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Studies
Immunovant (IMVT) has announced positive results from two key clinical studies. The Phase 3 study of batoclimab in Myasthenia Gravis (MG) met its primary endpoint, showing 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).
The initial results from Period 1 of the Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 2b study demonstrated an average improvement of 1.8 in adjusted INCAT disability scores across batoclimab arms. 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 plans to initiate pivotal studies for their lead asset IMVT-1402 in both MG and CIDP indications.
Immunovant (IMVT) ha annunciato risultati positivi da due studi clinici chiave. Lo studio di Fase 3 su batoclimab nella Miastenia Gravis (MG) ha raggiunto il suo obiettivo primario, mostrando miglioramenti significativi nei punteggi MG-ADL: un miglioramento di 5,6 punti nel braccio con dose più alta (riduzione dell'IgG del 74%) e un miglioramento di 4,7 punti nel braccio con dose più bassa (riduzione dell'IgG del 64%).
I risultati iniziali del Periodo 1 dello studio di Fase 2b sulla Neuropatia Periferica Demielinizzante Infiammatoria Cronica (CIDP) hanno dimostrato un miglioramento medio di 1,8 nei punteggi di disabilità INCAT aggiustati nei bracci di batoclimab. È stato osservato un tasso di risposta dell'84% nei pazienti che hanno raggiunto oltre il 70% di riduzione dell'IgG.
Entrambi gli studi hanno confermato che riduzioni più profonde dell'IgG erano correlate a migliori risultati clinici. L'azienda prevede di avviare studi pivotal per il loro principale asset IMVT-1402 sia per le indicazioni di MG che di CIDP.
Immunovant (IMVT) ha anunciado resultados positivos de dos estudios clínicos clave. El estudio de Fase 3 de batoclimab en Miastenia Gravis (MG) cumplió su objetivo primario, mostrando mejoras significativas en las puntuaciones de MG-ADL: una mejora de 5.6 puntos en el grupo de dosis más alta (reducción del 74% de IgG) y una mejora de 4.7 puntos en el grupo de dosis más baja (reducción del 64% de IgG).
Los resultados iniciales del Período 1 del estudio de Fase 2b sobre Neuropatía Periférica Desmielinizante Crónica (CIDP) demostraron una mejora promedio de 1.8 en las puntuaciones de discapacidad INCAT ajustadas en los grupos de batoclimab. Se observó una tasa de respuesta del 84% en los pacientes que lograron más del 70% de reducción de IgG.
Ambos estudios confirmaron que reducciones más profundas de IgG estaban correlacionadas con mejores resultados clínicos. La empresa planea iniciar estudios pivotal para su activo principal IMVT-1402 en ambas indicaciones de MG y CIDP.
Immunovant (IMVT)는 두 가지 주요 임상 연구에서 긍정적인 결과를 발표했습니다. 중증 근무력증 (MG)에 대한 3상 연구에서 주요 목표를 달성했으며, MG-ADL 점수에서 유의미한 개선을 보였습니다: 고용량 그룹에서 5.6점 개선(74% IgG 감소)과 저용량 그룹에서 4.7점 개선(64% IgG 감소)이 나타났습니다.
만성 염증성 탈수초성 다발신경병증 (CIDP)에 대한 2b상 연구의 1기 초기 결과는 batoclimab 그룹에서 조정된 INCAT 장애 점수가 평균 1.8 개선되었음을 보여주었습니다. 70% 이상의 IgG 감소를 달성한 환자에서 84%의 반응률이 관찰되었습니다.
두 연구 모두 IgG 감소가 더 깊을수록 더 나은 임상 결과와 관련이 있음을 확인했습니다. 회사는 MG 및 CIDP 적응증에 대해 주요 자산 IMVT-1402의 중요한 연구를 시작할 계획입니다.
Immunovant (IMVT) a annoncé des résultats positifs de deux études cliniques clés. L'étude de Phase 3 sur le batoclimab dans le cadre de la Myasthénie Gravis (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 % de l'IgG) et une amélioration de 4,7 points dans le groupe à dose plus faible (réduction de 64 % de l'IgG).
Les résultats initiaux de la Période 1 de l'étude de Phase 2b sur la Neuropathie Périphérique Démyelinisante Chronique (CIDP) ont démontré une amélioration moyenne de 1,8 des scores d'incapacité INCAT ajustés dans les groupes de batoclimab. Notamment, un taux de réponse de 84 % a été observé chez les patients atteignant plus de 70 % de réduction de l'IgG.
Les deux études ont confirmé que des réductions plus profondes de l'IgG étaient corrélées à de meilleurs résultats cliniques. L'entreprise prévoit de lancer des études pivot pour son actif principal IMVT-1402 pour les indications MG et CIDP.
Immunovant (IMVT) hat positive Ergebnisse aus zwei wichtigen klinischen Studien bekannt gegeben. Die Phase-3-Studie zu Batoclimab bei Myasthenia Gravis (MG) hat ihr primäres Ziel erreicht und signifikante Verbesserungen der MG-ADL-Werte gezeigt: 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).
Die ersten Ergebnisse aus Periode 1 der Phase-2b-Studie zur Chronischen Entzündlichen Demyelinisierenden Polyneuropathie (CIDP) zeigten eine durchschnittliche Verbesserung von 1,8 in den angepassten INCAT-Behinderungswerten über die Batoclimab-Arme hinweg. Bemerkenswert ist, dass bei Patienten, die eine Reduktion von über 70% IgG erreichten, eine Ansprechrate von 84% beobachtet wurde.
Beide Studien bestätigten, dass tiefere IgG-Reduktionen mit besseren klinischen Ergebnissen korrelierten. Das Unternehmen plant, entscheidende Studien für sein Hauptprodukt IMVT-1402 sowohl für MG- als auch für CIDP-Indikationen zu starten.
- Phase 3 MG study met primary endpoint with significant clinical improvements
- Strong CIDP Phase 2b results with 84% responder rate in high IgG reduction group
- Consistent correlation between IgG reduction and clinical benefits across studies
- Advancement to pivotal studies for lead asset IMVT-1402
- None.
Insights
Immunovant's positive Phase 3 results for batoclimab represent a significant clinical milestone that validates the company's FcRn inhibition approach. The MG study hit its primary endpoint with impressive improvements in the MG-ADL score: 5.6 points in the higher dose arm and 4.7 points in the lower dose arm. These are substantial clinical benefits that exceed what's typically considered meaningful.
The correlation between IgG reduction levels and clinical outcomes provides compelling evidence for their therapeutic approach. Patients achieving greater than 70% IgG reduction in the CIDP study showed an 84% responder rate, suggesting dose-dependent efficacy. This dose-response relationship strengthens confidence in the drug's mechanism and potential utility across multiple autoimmune conditions.
These results position Immunovant competitively in the emerging FcRn inhibitor landscape. While current FcRn inhibitors have shown efficacy, these data suggest batoclimab's deeper IgG reduction could translate to superior clinical outcomes. With INDs active and pivotal studies for lead asset IMVT-1402 imminent, Immunovant now has clinical validation supporting accelerated development across multiple indications, significantly de-risking their pipeline and enhancing Roivant's portfolio value.
From a clinical perspective, these batoclimab results represent meaningful advancements for patients with both MG and CIDP. In MG, the 5.6 and 4.7 point improvements in MG-ADL scores significantly exceed the 2-point threshold typically considered clinically meaningful. For context, this level of symptom reduction would translate to substantial quality-of-life improvements for patients struggling with daily activities like speaking, swallowing, and basic mobility.
The CIDP findings are particularly noteworthy given the treatment options available. The 1.8 point improvement in INCAT disability scores and 84% responder rate in patients with >70% IgG reduction suggest potential for meaningful functional improvements. Current CIDP treatments involve cumbersome IV immunoglobulin infusions or plasma exchange, so an effective subcutaneous option would represent a significant therapeutic advancement.
The consistent correlation between IgG reduction and clinical benefits across both indications strengthens the biological rationale for this approach. This mechanism-based validation suggests batoclimab and the upcoming IMVT-1402 could potentially address a spectrum of antibody-mediated neurological conditions that currently lack satisfactory treatments, potentially transforming management paradigms for these debilitating autoimmune neurological disorders.
- 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 | Placebo | Batoclimab 340mg | Batoclimab 680mg |
| (% AChR+ Population) | (QW)^ | (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 “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.
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.
About Roivant
Roivant (Nasdaq: ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, www.roivant.com.
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Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors.
Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
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FAQ
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