INmune Bio Inc. Announces Final Enrollment of 208 Patients in Phase 2 Trial in Early Alzheimer's Disease
INmune Bio has completed patient randomization in its Phase 2 trial for Early Alzheimer's Disease (AD02), with a total of 208 enrolled patients. The global, blinded trial focuses on patients with elevated neuroinflammation biomarkers, with 56% categorized as mild AD and 44% as MCI. The study utilizes XPro™, targeting glial cells to reduce neuroinflammation and improve brain function. The primary endpoint measures cognitive function changes after 24 weeks using EMACC and CDR-SB metrics. Top-line cognitive results are expected in the second quarter of 2025.
INmune Bio ha completato la randomizzazione dei pazienti nel suo studio di Fase 2 per la malattia di Alzheimer precoce (AD02), con un totale di 208 pazienti arruolati. Lo studio globale, in cieco, si concentra su pazienti con biomarcatori di neuroinfiammazione elevati, con il 56% classificati come AD lieve e il 44% come MCI. La ricerca utilizza XPro™, mirato alle cellule gliali per ridurre la neuroinfiammazione e migliorare la funzione cerebrale. L'obiettivo primario misura i cambiamenti nella funzione cognitiva dopo 24 settimane utilizzando le metriche EMACC e CDR-SB. Si prevedono risultati cognitivi preliminari nel secondo trimestre del 2025.
INmune Bio ha completado la aleatorización de pacientes en su ensayo de Fase 2 para la enfermedad de Alzheimer temprana (AD02), con un total de 208 pacientes inscritos. El ensayo global, en doble ciego, se centra en pacientes con biomarcadores de neuroinflamación elevados, con el 56% clasificados como AD leve y el 44% como MCI. El estudio utiliza XPro™, que se dirige a las células gliales para reducir la neuroinflamación y mejorar la función cerebral. El objetivo primario mide los cambios en la función cognitiva después de 24 semanas utilizando métricas EMACC y CDR-SB. Se esperan resultados cognitivos preliminares en el segundo trimestre de 2025.
INmune Bio는 조기 알츠하이머병(AD02)에 대한 2상 시험에서 환자 무작위 배정을 완료했으며, 총 208명의 등록 환자가 있습니다. 이 글로벌 이중 맹검 시험은 신경 염증 바이오마커 수준이 높은 환자에 중점을 두고 있으며, 56%는 경증 AD로, 44%는 MCI로 분류됩니다. 연구는 XPro™를 사용하여 신경 염증을 줄이고 뇌 기능을 개선하기 위해 교세포를 목표로 하고 있습니다. 주요 목표는 EMACC 및 CDR-SB 지표를 사용하여 24주 후의 인지 기능 변화를 측정합니다. 주요 인지 결과는 2025년 2분기에 발표될 것으로 예상됩니다.
INmune Bio a terminé la randomisation des patients dans son essai de Phase 2 pour la maladie d'Alzheimer précoce (AD02), avec un total de 208 patients inscrits. L'essai mondial, en aveugle, se concentre sur des patients ayant des biomarqueurs d'inflammation neuro élevée, avec 56 % classés comme AD léger et 44 % comme MCI. L'étude utilise XPro™, ciblant les cellules gliales pour réduire l'inflammation neuro et améliorer la fonction cérébrale. L'objectif principal mesure les changements de fonction cognitive après 24 semaines en utilisant les métriques EMACC et CDR-SB. Les résultats cognitifs préliminaires sont attendus au deuxième trimestre de 2025.
INmune Bio hat die Randomisierung der Patienten in seiner Phase-2-Studie zur frühen Alzheimer-Krankheit (AD02) abgeschlossen, mit insgesamt 208 eingeschriebenen Patienten. Die globale, placebokontrollierte Studie konzentriert sich auf Patienten mit erhöhten Biomarkern für Neuroentzündungen, wobei 56% als leichte AD und 44% als MCI eingestuft werden. Die Studie verwendet XPro™, das auf Gliazellen abzielt, um Neuroentzündungen zu reduzieren und die Gehirnfunktion zu verbessern. Der primäre Endpunkt misst die Veränderungen der kognitiven Funktion nach 24 Wochen unter Verwendung der EMACC- und CDR-SB-Metriken. Die vorläufigen kognitiven Ergebnisse werden im zweiten Quartal 2025 erwartet.
- Successfully completed enrollment with 208 patients, exceeding target
- Well-balanced patient distribution between mild AD (56%) and MCI (44%)
- Clear timeline for top-line results in Q2 2025
- None.
Insights
The completion of patient enrollment in the Phase 2 AD02 trial marks a significant milestone for INmune Bio's XPro™ therapy. The 208-patient enrollment exceeds initial targets, with a balanced distribution between mild AD (
The enrichment criteria targeting patients with neuroinflammation as a primary cause of cognitive decline represents a targeted approach that could potentially increase the likelihood of demonstrating efficacy. The expected topline data readout in Q2 2025 will be important in determining XPro™'s potential in treating Early Alzheimer's Disease through its novel mechanism of targeting glial cells.
Boca Raton, Florida, Nov. 13, 2024 (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 announced today that it completed randomization of patients for its Phase 2 trial on Monday, November 11th. This global, blinded, randomized Phase 2 trial (the “AD02 trial”) is focused on patients with Early AD and biomarkers of elevated neuroinflammation.
“We are excited to have completed administering first doses to all patients enrolled in our phase 2 Alzheimer’s trial,” stated RJ Tesi PhD, the CEO of INmune Bio. “A global trial of this size is a major accomplishment for INmune and is a testament to the hard work and dedication of our team. The trial ended up overenrolled with a total of 208 patients,
AD02 is a global, blinded, randomized Phase II trial in patients with Early AD using XPro™. The trial uses enrichment criteria to focus the trial on patients with neuroinflammation as a cause of their cognitive decline. XPro™ targets glial cells that drive neuroinflammation in the brain to allow decreased neurodegeneration and demyelination with improved synaptic function and remyelination. The primary end-point of AD02 is change from baseline cognitive function after 24 weeks of therapy, measured using EMACC and CDR-SB.
About Neuroinflammation in AD
Neuroinflammation is chronic inflammation in the brain that is part of the natural aging process called inflammaging. Neuroinflammation is increased due to behavioral and genetic factors. Neuroinflammation has been increasingly recognized as a key contributor to the development and progression of neurodegenerative diseases, including Alzheimer's. Neuroinflammation is a key cause of nerve cell death and synaptic dysfunction that causes cognitive decline. Blocking neuroinflammation with XPro™ decreases neurodegeneration and improves synaptic function and promotes remyelination. There are many publications on the role of neuroinflammation in AD. A recent review can be found here.
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 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™), 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. 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.
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
Investor Contact:
Mike Moyer
Managing Director – LifeSci Advisors
mmoyer@lifesciadvisors.com
FAQ
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