INmune Bio to Present Phase 2 MINDFuL Trial Findings of XPro™ at the Alzheimer’s Association International Conference
INmune Bio (NASDAQ: INMB) will present additional analyses from its Phase 2 MINDFuL trial of XPro™, a selective soluble TNF inhibitor for Alzheimer's disease, at the AAIC in Toronto on July 29, 2025.
The trial enrolled 208 participants with early-stage Alzheimer's, randomized 2:1 to receive XPro™ or placebo. While the primary endpoint wasn't met in the overall mITT group, the treatment showed consistent benefits after 6 months in a subgroup with confirmed amyloid-beta pathology and multiple inflammation biomarkers.
Dr. Sharon Cohen will present the findings, and INmune Bio plans to publish results by mid-August while seeking strategic partnerships for XPro™'s further development.
INmune Bio (NASDAQ: INMB) presenterà ulteriori analisi del suo studio di Fase 2 MINDFuL su XPro™, un inibitore selettivo del TNF solubile per la malattia di Alzheimer, durante l'AAIC a Toronto il 29 luglio 2025.
Lo studio ha arruolato 208 partecipanti con Alzheimer in fase iniziale, randomizzati in rapporto 2:1 a ricevere XPro™ o placebo. Sebbene l'endpoint primario non sia stato raggiunto nel gruppo mITT complessivo, il trattamento ha mostrato benefici costanti dopo 6 mesi in un sottogruppo con patologia confermata da amiloide-beta e diversi biomarcatori infiammatori.
La Dott.ssa Sharon Cohen presenterà i risultati e INmune Bio prevede di pubblicarli entro metà agosto, cercando al contempo partnership strategiche per lo sviluppo futuro di XPro™.
INmune Bio (NASDAQ: INMB) presentará análisis adicionales de su ensayo de Fase 2 MINDFuL con XPro™, un inhibidor selectivo del TNF soluble para la enfermedad de Alzheimer, en el AAIC en Toronto el 29 de julio de 2025.
El ensayo incluyó a 208 participantes con Alzheimer en etapa temprana, asignados aleatoriamente en una proporción 2:1 para recibir XPro™ o placebo. Aunque el objetivo principal no se cumplió en el grupo mITT global, el tratamiento mostró beneficios consistentes después de 6 meses en un subgrupo con patología confirmada de beta-amiloide y múltiples biomarcadores de inflamación.
La Dra. Sharon Cohen presentará los hallazgos, y INmune Bio planea publicar los resultados a mediados de agosto mientras busca alianzas estratégicas para el desarrollo futuro de XPro™.
INmune Bio (NASDAQ: INMB)는 2025년 7월 29일 토론토에서 열리는 AAIC에서 알츠하이머병 치료를 위한 선택적 가용성 TNF 억제제 XPro™의 2상 MINDFuL 임상시험 추가 분석 결과를 발표할 예정입니다.
이 임상시험에는 초기 알츠하이머 환자 208명이 등록되어 2:1 비율로 XPro™ 또는 위약을 투여받았습니다. 전체 mITT 그룹에서는 주요 평가변수를 달성하지 못했으나, 아밀로이드 베타 병리와 여러 염증 바이오마커가 확인된 하위 그룹에서 6개월 후 일관된 치료 효과가 나타났습니다.
샤론 코헨 박사가 결과를 발표할 예정이며, INmune Bio는 8월 중순까지 결과를 출판하고 XPro™의 추가 개발을 위한 전략적 파트너십을 모색할 계획입니다.
INmune Bio (NASDAQ : INMB) présentera des analyses complémentaires de son essai de phase 2 MINDFuL sur XPro™, un inhibiteur sélectif du TNF soluble pour la maladie d'Alzheimer, lors de l'AAIC à Toronto le 29 juillet 2025.
L'essai a inclus 208 participants atteints d'Alzheimer à un stade précoce, randomisés selon un ratio de 2:1 pour recevoir XPro™ ou un placebo. Bien que le critère principal n'ait pas été atteint dans l'ensemble du groupe mITT, le traitement a montré des bénéfices constants après 6 mois dans un sous-groupe avec une pathologie amyloïde-bêta confirmée et plusieurs biomarqueurs d'inflammation.
La Dre Sharon Cohen présentera les résultats, et INmune Bio prévoit de publier les données d'ici mi-août tout en recherchant des partenariats stratégiques pour le développement futur de XPro™.
INmune Bio (NASDAQ: INMB) wird am 29. Juli 2025 auf der AAIC in Toronto weitere Analysen seiner Phase-2-Studie MINDFuL zu XPro™, einem selektiven löslichen TNF-Inhibitor für die Alzheimer-Krankheit, vorstellen.
Die Studie schloss 208 Teilnehmer mit frühstadialem Alzheimer ein, die im Verhältnis 2:1 randomisiert wurden, um XPro™ oder Placebo zu erhalten. Obwohl der primäre Endpunkt in der gesamten mITT-Gruppe nicht erreicht wurde, zeigte die Behandlung nach 6 Monaten konsistente Vorteile in einer Untergruppe mit bestätigter Amyloid-Beta-Pathologie und mehreren Entzündungs-Biomarkern.
Dr. Sharon Cohen wird die Ergebnisse präsentieren, und INmune Bio plant, die Resultate bis Mitte August zu veröffentlichen und strategische Partnerschaften für die weitere Entwicklung von XPro™ zu suchen.
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Insights
INmune Bio's XPro missed primary endpoint in Phase 2 Alzheimer's trial but showed potential benefit in inflammation biomarker subgroup.
The Phase 2 MINDFuL trial results for INmune Bio's XPro™ reveal a mixed clinical outcome that requires careful interpretation. While the trial failed to meet its primary endpoint in the modified intent-to-treat population, the company has identified a responsive subgroup showing promising signals. Specifically, patients with confirmed amyloid-beta pathology plus at least two blood biomarkers of systemic inflammation demonstrated consistent benefits across cognitive, behavioral, and biomarker measures after 6 months of treatment.
This subgroup analysis represents a crucial potential path forward for XPro™, a selective soluble TNF inhibitor targeting neuroinflammation in early-stage Alzheimer's disease. The 208-patient trial design was scientifically sound, employing a 2:1 randomization ratio and using the Early Mild Alzheimer's Cognitive Composite (EMACC) to measure cognitive changes.
The company's announcement that they're seeking a strategic partnership indicates they likely need additional resources to advance XPro™ into larger trials. This suggests management recognizes both the potential value of their neuroinflammation approach and the substantial capital requirements for late-stage Alzheimer's development. The upcoming presentation at AAIC and planned publication in mid-August will provide the scientific community with more comprehensive data to evaluate XPro's therapeutic potential in this difficult-to-treat disease space.
Boca Raton, July 24, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) announced today that additional analyses from its Phase 2 MINDFuL trial evaluating XPro™, a novel selective soluble TNF inhibitor, will be released in an oral presentation at the Alzheimer’s Association International Conference (AAIC) in Toronto, Canada. The presentation, to be given by Dr. Sharon Cohen, is scheduled in a Developing Topics session on Tuesday, July 29, 2025, between 2:00 and 3:30 PM ET in room 718.
The MINDFuL trial is a double-blind, Phase 2 proof-of-concept study examining the potential of XPro™ to slow cognitive decline in early-stage Alzheimer’s disease (AD) by targeting neuroinflammation. The trial enrolled 208 participants with early AD who had one or more biomarkers of inflammation — elevated C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), hemoglobin A1c (HbA1c), or an ApoE4 allele. Participants received XPro™ or placebo in a 2:1 ratio, respectively, for 24 weeks, with changes in cognition measured via the Early Mild Alzheimer’s Cognitive Composite (EMACC).
While the primary endpoint was not met in the overall modified-intent-to-treat mITT group, key changes in clinical measures of cognition, behavior, and AD-related biomarkers demonstrated a consistent benefit of treatment with XProTM after 6 months in a subpopulation of patients with biomarker confirmed amyloid-beta (Aβ) pathology and ≥2 of the blood biomarkers of systemic inflammation.
“We are encouraged by the promising findings of the MINDFuL trial, which highlight the potential of XPro™ to address neuroinflammation in Alzheimer’s disease,” said Dr. CJ Barnum, Vice President of CNS Drug Development at INmune Bio. “These meaningful results reinforce our commitment to developing this therapy that could significantly impact patients and their families.”
Neurologist Dr. Sharon Cohen, site principal investigator of the MINDFuL trial and medical director of the Toronto Memory Program, will deliver the conference presentation. “I’m pleased to share more of this eagerly anticipated data with the Alzheimer’s community,” stated Dr. Cohen. “Targeting inflammation through XPro™ offers a novel and exciting therapeutic approach that could enhance outcomes for individuals with Alzheimer’s, whether used alone or in combination with other treatments.”
INmune Bio anticipates submitting a publication by mid-August of the MINDFuL Phase 2 study results. Additionally, the company is seeking a strategic partnership to accelerate the further development of XPro™ as a treatment for Alzheimer’s disease.
Acknowledgements
INmune Bio wishes to extend their gratitude to the MINDFuL participants, caregivers, site staff, vendors, and any others who supported the efforts of this proof-of-concept Phase 2 clinical trial.
About MINDFuL (NCT05318976)
The MINDFuL trial was an international, blinded, randomized Phase 2 trial in participants with Early AD with biomarkers of elevated neuroinflammation. Early AD includes patients with MCI (mild cognitive impairment) and mild AD. Participants were required to have at least one of four biomarkers of inflammation – elevated CRP, HbA1c, ESR or at least one APOE ε4 allele. Participants received either XPro™ or placebo (2:1 ratio) for 6 months by subcutaneous injection given once per week. The cognitive endpoint was change from baseline on the EMACC composite. For more information on the MINDFuL clinical trial, please visit www.clinicaltrials.gov or www.inmunebio.com
About XPro™
XPro™ is an advanced tumor necrosis factor (TNF) inhibitor that targets soluble TNF (sTNF) while preserving trans-membrane TNF (tmTNF) and TNF receptors. By reducing neuroinflammation, XPro™ may offer significant benefits for patients with neurologic disorders, potentially enhancing cognitive function and supporting neuronal communication.
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 allogeneic, pooled, 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.
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 related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, including the results of the Phase 2 MINDFuL trial, the timing of key milestones, future plans or expectations for the treatment of XPro™, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates 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 several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDstrom™, XPro1595 (XPro™, pegipanermin), and INKmune®™ have either finished clinical trials, are still in clinical trials or are 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 to reflect any event or circumstance that may arise after the date of this release.
Company Contact:
David Moss
Chief Financial Officer
(561) 710-0512
info@inmunebio.com
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
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