INmune Bio Inc. Presents Baseline Demographics and Disease Profiles of Participants in the MINDFuL Phase II Study
INmune Bio (NASDAQ: INMB) has presented baseline demographics for its MINDFuL Phase II trial studying XPro™ in early Alzheimer's disease (AD) patients. The study includes 208 participants, with 44% diagnosed with MCI and 56% with mild AD, averaging 72 years of age.
The trial features a 2:1 randomization of XPro™ 1.0 mg/kg versus placebo, administered weekly for 23 weeks. All enrolled patients exhibited biomarkers of inflammation, with 69.2% being APOE ε4 carriers and 64.4% meeting multiple enrichment biomarker criteria. The study's primary endpoint is the change in cognitive scores measured by EMACC, with secondary endpoints including CDR-SB, E-Cog, ADL, and Neuropsychiatric Inventory.
The screen failure rate was 72%, primarily due to disease severity measured by MMSE. Topline results are expected in June 2025.
INmune Bio (NASDAQ: INMB) ha presentato i dati demografici di base per il suo studio MINDFuL di Fase II che esamina XPro™ in pazienti con malattia di Alzheimer (AD) in fase iniziale. Lo studio include 208 partecipanti, di cui il 44% diagnosticati con MCI e il 56% con AD lieve, con un'età media di 72 anni.
Il trial prevede una randomizzazione 2:1 di XPro™ 1.0 mg/kg rispetto al placebo, somministrato settimanalmente per 23 settimane. Tutti i pazienti arruolati hanno mostrato biomarcatori di infiammazione, con il 69,2% che sono portatori di APOE ε4 e il 64,4% che soddisfano più criteri di biomarcatori di arricchimento. L'obiettivo primario dello studio è il cambiamento nei punteggi cognitivi misurati tramite EMACC, con obiettivi secondari che includono CDR-SB, E-Cog, ADL e Neuropsychiatric Inventory.
Il tasso di fallimento dello screening è stato del 72%, principalmente a causa della gravità della malattia misurata tramite MMSE. I risultati preliminari sono attesi per giugno 2025.
INmune Bio (NASDAQ: INMB) ha presentado los datos demográficos básicos para su ensayo MINDFuL de Fase II que estudia XPro™ en pacientes con enfermedad de Alzheimer (AD) en etapas tempranas. El estudio incluye 208 participantes, con un 44% diagnosticados con MCI y un 56% con AD leve, con una edad promedio de 72 años.
El ensayo presenta una aleatorización 2:1 de XPro™ 1.0 mg/kg frente a placebo, administrado semanalmente durante 23 semanas. Todos los pacientes inscritos mostraron biomarcadores de inflamación, con un 69,2% siendo portadores de APOE ε4 y un 64,4% cumpliendo con múltiples criterios de biomarcadores de enriquecimiento. El objetivo primario del estudio es el cambio en las puntuaciones cognitivas medido por EMACC, con objetivos secundarios que incluyen CDR-SB, E-Cog, ADL y Neuropsychiatric Inventory.
La tasa de fallos en la selección fue del 72%, principalmente debido a la gravedad de la enfermedad medida por MMSE. Se esperan resultados preliminares en junio de 2025.
INmune Bio (NASDAQ: INMB)는 초기 알츠하이머병(AD) 환자에서 XPro™를 연구하는 MINDFuL 2상 시험의 기준 인구통계 데이터를 발표했습니다. 이 연구에는 208명의 참가자가 포함되며, 그 중 44%는 MCI로 진단받았고 56%는 경증 AD로 진단받았으며, 평균 연령은 72세입니다.
시험은 XPro™ 1.0 mg/kg에 대한 2:1 무작위 배정을 특징으로 하며, 23주 동안 매주 투여됩니다. 모든 등록된 환자는 염증 바이오마커를 보였으며, 69.2%가 APOE ε4 보유자였고 64.4%가 여러 바이오마커 기준을 충족했습니다. 연구의 주요 목표는 EMACC로 측정한 인지 점수의 변화이며, 부차적 목표로는 CDR-SB, E-Cog, ADL 및 신경정신과적 평가가 포함됩니다.
스크리닝 실패율은 72%였으며, 주로 MMSE로 측정한 질병의 심각성 때문이었습니다. 최종 결과는 2025년 6월에 발표될 예정입니다.
INmune Bio (NASDAQ: INMB) a présenté les données démographiques de base pour son essai MINDFuL de Phase II étudiant XPro™ chez des patients atteints de la maladie d'Alzheimer (AD) à un stade précoce. L'étude comprend 208 participants, dont 44 % ont été diagnostiqués avec un MCI et 56 % avec une AD légère, avec un âge moyen de 72 ans.
L'essai présente une randomisation 2:1 de XPro™ 1,0 mg/kg par rapport au placebo, administré chaque semaine pendant 23 semaines. Tous les patients inscrits ont montré des biomarqueurs d'inflammation, avec 69,2 % portant l'APOE ε4 et 64,4 % répondant à plusieurs critères de biomarqueurs d'enrichissement. L'objectif principal de l'étude est le changement des scores cognitifs mesurés par EMACC, avec des objectifs secondaires comprenant CDR-SB, E-Cog, ADL et Neuropsychiatric Inventory.
Le taux d'échec du dépistage était de 72 %, principalement en raison de la gravité de la maladie mesurée par le MMSE. Les résultats préliminaires sont attendus en juin 2025.
INmune Bio (NASDAQ: INMB) hat die Basisdemografie für seine MINDFuL Phase-II-Studie vorgestellt, die XPro™ bei Patienten mit frühzeitiger Alzheimer-Krankheit (AD) untersucht. Die Studie umfasst 208 Teilnehmer, von denen 44% mit MCI und 56% mit leichter AD diagnostiziert wurden, mit einem Durchschnittsalter von 72 Jahren.
Die Studie sieht eine 2:1 Randomisierung von XPro™ 1,0 mg/kg gegenüber Placebo vor, das wöchentlich über einen Zeitraum von 23 Wochen verabreicht wird. Alle eingeschlossenen Patienten wiesen Biomarker für Entzündungen auf, wobei 69,2% Träger von APOE ε4 waren und 64,4% mehrere Kriterien für Enrichment-Biomarker erfüllten. Der primäre Endpunkt der Studie ist die Veränderung der kognitiven Werte, die mit EMACC gemessen wird, während sekundäre Endpunkte CDR-SB, E-Cog, ADL und Neuropsychiatric Inventory umfassen.
Die Screening-Fehlerrate betrug 72%, hauptsächlich aufgrund der Schwere der Erkrankung, die mit MMSE gemessen wurde. Die vorläufigen Ergebnisse werden im Juni 2025 erwartet.
- Well-characterized patient cohort with confirmed inflammation biomarkers
- High percentage (69.2%) of APOE ε4 carriers in trial population
- Patient characteristics align with successful Phase III trials in Early AD
- Multiple secondary endpoints to validate efficacy
- High screen failure rate of 72% in patient recruitment
- Results not expected until June 2025
- Early-stage trial with no assurance of specific outcomes
Insights
INmune Bio's MINDFuL Phase II trial update offers important insights into their Alzheimer's disease program but no efficacy signals yet. The company has successfully enrolled 208 patients with early Alzheimer's disease (44% with MCI and 56% with mild AD), all showing biomarkers of inflammation—the key target of their XPro™ therapy.
The patient population appears well-characterized with 69.2% being APOE ε4 carriers and 64.4% meeting multiple inflammatory biomarker criteria. Management's comparison to patient populations in successful Phase III AD trials is noteworthy, suggesting appropriate trial design and patient selection. However, this remains purely demographic data with no treatment outcomes yet available.
The primary endpoint (change in EMACC cognitive scores) appears well-validated for early AD, with baseline correlations to established measures like MMSE and CDR-SB demonstrating construct validity. The high screen failure rate (72%) indicates rigorous patient selection, potentially increasing the likelihood of detecting a true drug effect if present.
With topline results expected in June 2025, this update merely confirms the trial is proceeding as planned. The market's attention should remain focused on the upcoming data readout, as this presentation contains no efficacy signals that would alter the risk/reward profile of INmune's Alzheimer's program.
MINDFuL Phase II Blinded, Randomized, Placebo-Controlled Data Anticipated June 2025
Boca Raton, Florida, April 01, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, is presenting a poster at the annual International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurologic Disorders taking place in Vienna, Austria April 1-5 2025. AD/PD is the largest Alzheimer’s conference in Europe. The poster details the demographics and biomarker status of patients at the time of enrollment in the MINDFul Phase II blinded, randomized trial in patients with early AD and biomarkers of inflammation.
Patients enrolled in the MINDfuL trial (N=208) were diagnosed with either MCI (n=92,
The primary endpoint in the MINDFuL trial is change from baseline in cognitive scores measured with the Early and Mild Alzheimer's Cognitive Composite (EMACC). As reported elsewhere, the EMACC was designed specifically to serve as an objective outcome measure in Early AD clinical trials. The EMACC provides improved sensitivity for detection and tracking
Baseline scores on the EMACC were higher in the MCI vs mAD groups and correlated with scores on both the MMSE and CDR-SB, indicating good construct validity for the primary endpoint.
The screen failure rate in the MINDfuL trial was
“Preliminary analyses of blinded data at baseline show enrollment of a well-characterized cohort of patients with Early AD and biomarker confirmed inflammation indicative of immune system dysfunction,” said CJ Barnum, VP of CNS Drug Development at INmune Bio. “
Secondary endpoints in the MINDFuL trial include the CDR-SB, E-Cog, ADL and Neuropsychiatric Inventory (NPI) instruments, along with blood biomarker and neuroimaging outcomes. Baseline demographics, disease characteristics and study design details will be presented on April 4-5 during poster session 2 at AD/PD 2025:
Poster #294: ALZHEIMER’S DISEASE (AD) AND IMMUNE DYSFUNCTION: BASELINE DEMOGRAPHICS AND DISEASE CHARACTERISTICS FROM A PHASE-2 STUDY OF XPRO1595 IN EARLY AD
Topline results of the MINDFuL trial will be reported in June 2025.
About INmune Bio Inc.
INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has three product platforms: 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 Mild Alzheimer’s disease, Mild Cognitive Impairment 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 and is currently in trials in metastatic castration-resistance prostate cancer. The third program, CORDStrom™, is a proprietary pooled, allogeneic, human umbilical cord-derived mesenchymal Stromal/Stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa. INmune Bio’s product platforms utilize a precision medicine approach for diseases driven by chronic inflammation and cancer. 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. CORDStrom™, 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.
David Moss
Co-founder and Chief Financial Officer
(858) 964-3720
info@inmunebio.com
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
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