INmune Bio Announces Results of Additional Blinded Interim Analysis of Phase 2 Alzheimer's Disease Trial Demonstrating Correlation between EMACC and CDR-SB Endpoints
INmune Bio Inc. (NASDAQ: INMB) announced results from an additional analysis of blinded data from its AD02 Phase II Alzheimer's Disease trial. The analysis showed exceptional performance of the novel cognitive measure EMACC and a highly significant correlation between EMACC and the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Key findings include:
1. A highly significant correlation (p<0.001) between baseline scores on EMACC and CDR-SB.
2. High reliability of EMACC with a correlation of 0.93 between screening and first study visit.
3. EMACC's ability to differentiate between disease stages with an effect size of 0.87 (p<.0001).
The company believes these results validate their trial design and endpoint selection, potentially de-risking their clinical program compared to traditional AD drug development approaches.
INmune Bio Inc. (NASDAQ: INMB) ha annunciato i risultati di un'analisi aggiuntiva dei dati in cieco del suo trial di fase II per la malattia di Alzheimer AD02. L'analisi ha mostrato un'eccezionale performance della nuova misura cognitiva EMACC e una correlazione altamente significativa tra EMACC e il Clinical Dementia Rating-Sum of Boxes (CDR-SB). I risultati chiave includono:
1. Una correlazione altamente significativa (p<0.001) tra i punteggi di base su EMACC e CDR-SB.
2. Alta affidabilità di EMACC con una correlazione di 0.93 tra screening e prima visita dello studio.
3. La capacità di EMACC di distinguere tra le fasi della malattia con una dimensione dell'effetto di 0.87 (p<.0001).
L'azienda ritiene che questi risultati convalidino il loro disegno sperimentale e la selezione degli endpoint, potenzialmente riducendo i rischi del loro programma clinico rispetto agli approcci tradizionali nello sviluppo di farmaci per l'AD.
INmune Bio Inc. (NASDAQ: INMB) anunció los resultados de un análisis adicional de datos ciegos de su ensayo AD02 de fase II para la enfermedad de Alzheimer. El análisis mostró un rendimiento excepcional de la nueva medida cognitiva EMACC y una correlación altamente significativa entre EMACC y el Clinical Dementia Rating-Sum of Boxes (CDR-SB). Los hallazgos clave incluyen:
1. Una correlación altamente significativa (p<0.001) entre las puntuaciones basales en EMACC y CDR-SB.
2. Alta fiabilidad de EMACC con una correlación de 0.93 entre la evaluación inicial y la primera visita del estudio.
3. La capacidad de EMACC para diferenciar entre las etapas de la enfermedad con un tamaño del efecto de 0.87 (p<.0001).
La empresa cree que estos resultados validan el diseño de su ensayo y la selección de los endpoints, lo que podría reducir el riesgo de su programa clínico en comparación con los enfoques tradicionales en el desarrollo de medicamentos para la enfermedad de Alzheimer.
INmune Bio Inc. (NASDAQ: INMB)은 알츠하이머병 2상 AD02 임상 시험의 블라인드 데이터를 추가로 분석한 결과를 발표했습니다. 분석 결과 새로운 인지 측정 도구 EMACC의 뛰어난 성능과 EMACC와 Clinical Dementia Rating-Sum of Boxes (CDR-SB) 간의 매우 중요한 상관관계가 나타났습니다. 주요 발견 사항은 다음과 같습니다:
1. EMACC와 CDR-SB의 기초 점수 간의 매우 중요한 상관관계 (p<0.001).
2. 초기 평가와 연구 첫 방문 간 EMACC의 신뢰성이 0.93으로 나타났습니다.
3. EMACC가 병기별 차별화 능력이 있으며, 효과 크기는 0.87 (p<.0001)입니다.
회사는 이 결과가 시험 설계 및 목표 선정의 타당성을 검증하며, 전통적인 알츠하이머 약물 개발 접근법에 비해 임상 프로그램의 리스크를 줄일 수 있다고 믿고 있습니다.
INmune Bio Inc. (NASDAQ: INMB) a annoncé les résultats d'une analyse complémentaire des données en aveugle de son essai clinique AD02 de phase II sur la maladie d'Alzheimer. L'analyse a montré une performance exceptionnelle de la nouvelle mesure cognitive EMACC et une correlation hautement significative entre EMACC et le Clinical Dementia Rating-Sum of Boxes (CDR-SB). Les principales conclusions comprennent :
1. Une corrélation hautement significative (p<0.001) entre les scores de base sur EMACC et CDR-SB.
2. Haute fiabilité d'EMACC avec une corrélation de 0.93 entre le dépistage et la première visite de l'étude.
3. La capacité d'EMACC à différencier les stades de la maladie avec une taille de l'effet de 0.87 (p<.0001).
L'entreprise estime que ces résultats valident la conception de son essai et la sélection des points d'évaluation, ce qui pourrait réduire les risques de son programme clinique par rapport aux approches traditionnelles du développement de médicaments pour la maladie d'Alzheimer.
INmune Bio Inc. (NASDAQ: INMB) gab die Ergebnisse einer zusätzlichen Analyse von verblindeten Daten seiner AD02 Phase-II-Studie zur Alzheimer-Krankheit bekannt. Die Analyse zeigte eine außergewöhnliche Leistung des neuartigen kognitiven Instruments EMACC und eine hochgradig signifikante Korrelation zwischen EMACC und der Clinical Dementia Rating-Sum of Boxes (CDR-SB). Wichtige Erkenntnisse umfassen:
1. Eine hochgradig signifikante Korrelation (p<0.001) zwischen den Ausgangswerten von EMACC und CDR-SB.
2. Hohe Zuverlässigkeit von EMACC mit einer Korrelation von 0.93 zwischen dem Screening und dem ersten Studienbesuch.
3. EMACCs Fähigkeit, zwischen Krankheitsstadien mit einer Effektgröße von 0.87 (p<.0001) zu differenzieren.
Das Unternehmen glaubt, dass diese Ergebnisse ihr Studiendesign und die Auswahl der Endpunkte validieren und potenziell das Risiko ihres klinischen Programms im Vergleich zu traditionellen Ansätzen der Alzheimer-Arzneimittelentwicklung verringern.
- Highly significant correlation (p<0.001) found between EMACC and CDR-SB, validating EMACC as a primary endpoint
- High reliability of EMACC with a 0.93 correlation between screening and first study visit
- EMACC demonstrates strong ability to differentiate between disease stages (effect size 0.87, p<.0001)
- Novel trial design potentially de-risks the clinical program compared to traditional AD drug development
- Enrollment expected to complete by end of current quarter, with topline data anticipated six months after last patient enrollment
- None.
Insights
The interim analysis of INmune Bio's Phase 2 Alzheimer's trial reveals promising results for their novel cognitive measure, EMACC. The highly significant correlation (p<0.001) between EMACC and CDR-SB scores validates EMACC's potential as a more precise tool for measuring cognitive changes in early Alzheimer's Disease (AD) patients.
Key strengths of EMACC include its high reliability (0.93 correlation) between screening and first visit and its ability to differentiate between disease stages with a large effect size (Cohen's d = 0.87, p<.0001). These factors suggest EMACC could provide more robust and replicable results with smaller sample sizes, potentially streamlining future AD trials.
However, it's important to note that while these results are encouraging, they are from a blinded interim analysis. The true efficacy of INmune Bio's treatment and EMACC's performance as an endpoint will only be clear after the full trial results are unblinded and analyzed.
INmune Bio's (NASDAQ: INMB) announcement could have significant implications for both the company and the broader Alzheimer's drug development landscape. The validation of EMACC as a potentially superior cognitive measure could streamline future clinical trials, reducing costs and time-to-market for AD therapies.
For investors, this news might signal a competitive advantage for INmune Bio in the lucrative AD market. The company's innovative approach, combining EMACC with biomarkers of inflammation, could attract partnerships or acquisition interest from larger pharmaceutical companies.
However, it's important to temper optimism with caution. While the interim results are promising, the full trial data, expected about six months after enrollment completion, will be crucial. Additionally, regulatory acceptance of EMACC as a primary endpoint for future trials remains uncertain. Investors should closely monitor upcoming milestones, including the completion of enrollment and eventual topline data release.
BOCA RATON, Fla., Sept. 17, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology and inflammation company, today announced that results of additional analysis of blinded data from its AD02 Phase II Alzheimer's Disease (AD) trial demonstrated exceptional performance of the novel cognitive measure EMACC, as well as highly significant correlation between EMACC and the Clinical Dementia Rating-Sum of Boxes (CDR-SB), the accepted endpoint for AD trials.
“Based on how the EMACC was developed, we expected a robust correlation between EMACC and CDR when used side-by-side in a clinical trial, and this analysis, while confirming our hypothesis, also validates the selection of the cognitive endpoints measured in the AD02 trial,” said Judith Jaeger, Ph.D., an internationally recognized neuropsychologist and part of the team that partnered with biopharma to develop EMACC in 2017. “The CDR-SB was not designed to measure cognitive change in clinical trials; it was developed as a staging instrument and relies largely on subjective assessments. The EMACC, on the other hand, was empirically derived to measure cognitive change in early AD patients objectively. This high degree of precision offers a more accurate assessment of cognitive function.”
Key Findings
- Statistical Correlation: An independent review confirmed a highly significant correlation (p<0.001) between baseline scores on EMACC and CDR-SB, the secondary endpoint in the AD02 trial. CDR-SB is the clinical rating scale most used in AD registration studies.
- Reliability: The correlation of EMACC when measured during the screening process and again at the first study visit before treatment was found to be 0.93. Higher precision produces results that are more robust and replicable with smaller sample sizes.
- Differentiation Capability: The difference in EMACC performance between patients with CDR global ratings of 0.5 (prodromal AD) and those rated 1.0 (mild dementia) was very large, with an effect size (Cohen’s d) of 0.87 (p<.0001). This demonstrates EMACC's ability to accurately differentiate between disease stages, highlighting its sensitivity and precision.
“We believe the novel design elements used in our AD02 Phase 2 trial significantly de-risk our clinical program compared to traditional trial designs in AD drug development, and this analysis overwhelmingly supports our decision to use EMACC as the primary endpoint while further validating both size and duration of the trial,” said C.J. Barnum, Ph.D., VP of Neuroscience at INmune. “EMACC more accurately measures cognitive changes in early AD patients with biomarkers of inflammation, a key criteria for enrollment in our trial. We look forward to completing enrollment near the end of this quarter and to announcing topline data approximately six months from the last patient enrolled.”
A quick video from Dr. CJ Barnum describing the results from this interim analysis can be found by clicking here or following this link: https://youtu.be/6Api49YG_U0.
About EMACC
The Early AD/ MCI Alzheimer’s Cognitive Composite (EMACC) is an empirically derived cognitive measure composed of standardized and widely used neuropsychological tests. These tests, in combination, showed the greatest sensitivity to change in Early Alzheimer’s Disease (AD) patients over two years of follow-up. The performance characteristics of EMACC in early AD were first reported by Biogen at CTAD in 2021. Notably, EMACC was also found to be strongly associated with biological markers of inflammation in the Alzheimer’s Disease Neuroimaging Initiative (ADNI) AD study.
Conclusion
These data overwhelmingly confirm the suitability of EMACC as a primary endpoint in early AD studies.
About the Expert Consultant
Judith Jaeger, PhD, is the principal developer of the EMACC. Judith Jaeger PhD is founder of CognitionMetrics, a prominent neurocognition consulting firm. Dr. Jaeger is an internationally recognized expert in designing cognitive function testing programs to use in clinical trials with more than two decades’ experience.
About XPro™
XPro™ is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro™ may potentially have substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.
About INmune Bio Inc.
INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage inflammation and immunology biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms that are both in clinical trials: The Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat cancer (INB03™), Early Alzheimer’s disease and treatment-resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune™ developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies, and chronic inflammation. To learn more, please visit www.inmunebio.com.
Forward-Looking Statements
Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, XPro1595 (XPro™), and INKmune™ are still in clinical trials or preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.
INmune Bio Contact:
David Moss
Chief Financial Officer
(858) 964-3720
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
Investor Contact:
Mike Moyer
Managing Director – LifeSci Advisors
mmoyer@lifesciadvisors.com
FAQ
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