Immunovant Provides Update on Graves’ Disease Development Program
Immunovant (Nasdaq: IMVT) reported positive results from its Phase 2a trial of batoclimab in Graves' Disease. Key findings include:
1. 76% response rate with high-dose batoclimab at week 12
2. 56% ATD-Free response rate at week 12
3. Strong correlation between IgG lowering and clinical outcomes
The company also announced FDA clearance for an IMVT-1402 pivotal trial in Graves' Disease, expected to start by year-end. Market research indicates 25-30% of Graves' Disease patients are uncontrolled on antithyroid drugs annually, representing a significant commercial opportunity. Immunovant believes these results validate the unmet medical need and demonstrate strong response rates in this population.
Immunovant (Nasdaq: IMVT) ha riportato risultati positivi dal suo trial di Fase 2a di batoclimab nella Malattia di Graves. I risultati principali includono:
1. Tasso di risposta del 76% con batoclimab ad alta dose alla settimana 12
2. Tasso di risposta ATD-Free del 56% alla settimana 12
3. Forte correlazione tra la riduzione dell'IgG e i risultati clinici
La società ha anche annunciato l'approvazione della FDA per un trial pivotale IMVT-1402 nella Malattia di Graves, che si prevede inizi entro la fine dell'anno. Le ricerche di mercato indicano che il 25-30% dei pazienti con Malattia di Graves non sono controllati con farmaci antitroidi annualmente, rappresentando un'opportunità commerciale significativa. Immunovant ritiene che questi risultati convalidano il bisogno medico insoddisfatto e dimostrano alti tassi di risposta in questa popolazione.
Immunovant (Nasdaq: IMVT) reportó resultados positivos de su ensayo de Fase 2a de batoclimab en la enfermedad de Graves. Los hallazgos clave incluyen:
1. Tasa de respuesta del 76% con batoclimab en dosis alta a la semana 12
2. Tasa de respuesta libre de ATD del 56% a la semana 12
3. Fuerte correlación entre la reducción de IgG y los resultados clínicos
La compañía también anunció la aprobación de la FDA para un ensayo pivotal de IMVT-1402 en la enfermedad de Graves, que se espera comience a finales de año. La investigación de mercado indica que el 25-30% de los pacientes con enfermedad de Graves no están controlados con medicamentos anti-tiroides anualmente, lo que representa una oportunidad comercial significativa. Immunovant cree que estos resultados validan la necesidad médica no satisfecha y demuestran altas tasas de respuesta en esta población.
Immunovant (Nasdaq: IMVT)는 그레이브스병에 대한 바토클리맙의 2a상 시험에서 긍정적인 결과를 보고했습니다. 주요 결과는 다음과 같습니다:
1. 12주 차 고용량 바토클리맙에 대한 76%의 반응률
2. 12주 차 ATD 자유 반응률 56%
3. IgG 감소와 임상 결과 간의 강한 상관관계
회사는 또한 그레이브스병에 대한 IMVT-1402 주요 시험에 대한 FDA 승인을 발표했으며, 연말까지 시작될 것으로 예상됩니다. 시장 조사에 따르면, 매년 25-30%의 그레이브스병 환자가 항갑상선 약물로는 조절되지 않으며, 이는 상당한 상업적 기회를 나타냅니다. Immunovant는 이러한 결과가 충족되지 않은 의료 필요성을 확인하고 이 인구에서 높은 반응률을 보여준다고 믿고 있습니다.
Immunovant (Nasdaq: IMVT) a rapporté des résultats positifs de son essai de Phase 2a de batoclimab dans la maladie de Graves. Les principaux résultats incluent :
1. Taux de réponse de 76 % avec batoclimab à forte dose à la semaine 12
2. Taux de réponse sans ATD de 56 % à la semaine 12
3. Forte corrélation entre la réduction de l'IgG et les résultats cliniques
La société a également annoncé l'approbation de la FDA pour un essai pivot IMVT-1402 dans la maladie de Graves, prévu pour débuter d'ici la fin de l'année. Les études de marché indiquent que 25 à 30 % des patients atteints de la maladie de Graves ne sont pas contrôlés par des médicaments antithyroïdiens chaque année, ce qui représente une opportunité commerciale significative. Immunovant estime que ces résultats valident le besoin médical non satisfait et démontrent des taux de réponse élevés dans cette population.
Immunovant (Nasdaq: IMVT) berichtete über positive Ergebnisse aus seiner Phase 2a-Studie mit Batoclimab bei Morbus Basedow. Zu den wichtigsten Ergebnissen gehören:
1. 76% Ansprechrate mit hochdosiertem Batoclimab in Woche 12
2. 56% ATD-freie Ansprechrate in Woche 12
3. Starke Korrelation zwischen IgG-Senkung und klinischen Ergebnissen
Das Unternehmen kündigte außerdem die FDA-Zulassung für eine IMVT-1402-Hauptstudie bei Morbus Basedow an, die voraussichtlich bis Ende des Jahres beginnen wird. Marktforschung zeigt, dass 25-30% der Morbus Basedow-Patienten jährlich mit Antithyreostatika nicht ausreichend kontrolliert sind, was eine bedeutende kommerzielle Chance darstellt. Immunovant ist der Ansicht, dass diese Ergebnisse den ungedeckten medizinischen Bedarf validieren und hohe Ansprechraten in dieser Population demonstrieren.
- 76% response rate achieved with high-dose batoclimab in patients uncontrolled on antithyroid drugs at week 12
- 56% ATD-Free response rate achieved in patients uncontrolled on antithyroid drugs at week 12
- Strong correlation observed between IgG lowering and clinical outcomes
- FDA clearance obtained for IMVT-1402 pivotal trial in Graves' Disease
- 25-30% of Graves' Disease patients per year are uncontrolled on ATDs, representing a significant commercial opportunity
- Lower dose batoclimab (340mg) resulted in reduced efficacy compared to higher dose (680mg)
- ATD-Free Response rate decreased from 56% to 36% with lower dose batoclimab
Insights
The Phase 2a trial results for batoclimab in Graves' Disease (GD) are highly promising. The 76% response rate and 56% ATD-Free response rate at week 12 with high-dose batoclimab are impressive, especially considering these patients were previously uncontrolled on antithyroid drugs (ATDs). The strong correlation between IgG reduction and clinical outcomes is particularly noteworthy, suggesting a dose-dependent efficacy.
The lower efficacy observed with the 340mg dose in weeks 13-24 further supports this dose-response relationship. This data strongly suggests that IMVT-1402, potentially offering greater IgG reduction, could indeed be a best-in-class therapy for GD. The FDA's clearance for a pivotal trial initiation by year-end is a significant milestone, potentially accelerating the path to market for this novel treatment option.
The market opportunity for a new GD treatment appears substantial. The company's claim that 25-30% of GD patients per year are uncontrolled on ATDs represents a significant unmet need. With minimal existing therapeutic options for these patients, a successful IMVT-1402 could capture a considerable market share.
The potential for a first-in-class and best-in-class treatment in this space could lead to rapid adoption and potentially premium pricing. The correlation between IgG reduction and clinical outcomes could also provide a clear differentiation point in marketing. However, it's important to monitor the competitive landscape, as success in this area might attract other players. The planned pivotal trial will be critical in confirming these early promising results and securing a strong market position.
This update significantly strengthens Immunovant's position in the autoimmune disease market. The positive Phase 2a results and FDA alignment on the pivotal trial design for IMVT-1402 reduce development risk and potentially accelerate time-to-market. This could positively impact the company's valuation and investor sentiment.
The identified market opportunity in GD patients uncontrolled on ATDs presents a clear revenue growth potential. If IMVT-1402 demonstrates superior efficacy in the pivotal trial, it could command premium pricing, driving strong revenue growth. However, investors should consider the costs associated with conducting the pivotal trial and potential future commercialization efforts. The company's cash position and burn rate will be important metrics to watch in the coming quarters as they progress towards potential commercialization.
- High dose batoclimab achieved
76% response rate in patients uncontrolled on antithyroid drugs (ATDs) at week 12 - High dose batoclimab achieved
56% ATD-Free response rate in patients uncontrolled on ATDs at week 12 - Strong correlation observed between degree of IgG lowering and clinical outcomes yields potential best-in-class and first-in-class opportunity for IMVT-1402 in Graves’ Disease (GD)
- Real world claims data indicates 25
-30% of Graves’ Disease patients per year are uncontrolled on ATDs with minimal to no existing therapeutic options representing an attractive commercial opportunity with limited competition - IND cleared with initiation of IMVT-1402 pivotal trial in GD expected by calendar year end
NEW YORK, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported positive results from the Phase 2a trial of batoclimab in Graves’ Disease. Immunovant also disclosed data from several proprietary market research studies that showed a consistent unmet need among ATD treated patients who are intolerant to, uncontrolled on or relapsed after ATDs. Finally, Immunovant also announced alignment with the U.S. Food & Drug Administration (FDA) and Investigational New Drug Application (IND) clearance with initiation of a pivotal trial of IMVT-1402 in GD expected by December 31, 2024.
As previously disclosed, the batoclimab phase 2a trial in uncontrolled GD enrolled patients who were hyperthyroid despite ATD therapy. Participants in the trial received 12 weeks of high dose batoclimab, 680 mg weekly by subcutaneous injection (SC) followed by 12 weeks of lower dose batoclimab, 340 mg weekly SC. At the end of the first 12 weeks, participants experienced a mean IgG reduction of
“We are thrilled to share these updates today which we believe validate a large and important degree of unmet medical need in patients uncontrolled on ATDs and which we believe demonstrate strong response rates in this same population,” said Pete Salzmann, M.D., chief executive officer of Immunovant. “We find the correlation between clinical response and IgG lowering impressive and believe this creates not only a potential first-in-class but also a potential best-in-class opportunity for IMVT-1402. We are very pleased to have aligned with the FDA on a pivotal trial design that we expect to initiate by the end of the year.”
Webcast Details
Immunovant will host a webcast at 8:00 a.m. ET today 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. 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.
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,” “anticipate,” “intend,” and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include, but are not limited to, statements regarding the potential benefits of IMVT-1402’s unique product attributes and potential first-in-class and best-in-class profile; the expected initiation of a pivotal trial of IMVT-1402 in GD and the timing thereof; and the potential commercial opportunity of IMVT-1402 as a treatment for GD. 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: Immunovant may not be able to protect or enforce its intellectual property rights; initial results or other preliminary analyses or results of early clinical trials may not be predictive of 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 number and 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 macroeconomic and geopolitical factors 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/or batoclimab; Immunovant is at various stages of clinical development for IMVT-1402 and batoclimab; and Immunovant will require additional capital to fund its operations and advance IMVT-1402 and batoclimab 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 August 6, 2024, 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.
Investor Contact:
Renee Barnett, MBA
Chief Financial Officer
Immunovant, Inc.
info@immunovant.com
FAQ
What were the key results of Immunovant's Phase 2a trial for batoclimab in Graves' Disease?
When is Immunovant (IMVT) expected to initiate the pivotal trial for IMVT-1402 in Graves' Disease?
What percentage of Graves' Disease patients are uncontrolled on antithyroid drugs according to Immunovant's market research?
How did the lower dose of batoclimab (340mg) compare to the higher dose (680mg) in Immunovant's Graves' Disease trial?
