OmniScience Inc. and INmune Bio Inc. Partner to Accelerate a Phase 2 Alzheimer’s Trial with Vivo, a Novel genAI Clinical Trial Control Tower
INmune Bio (NASDAQ: INMB) and OmniScience have partnered to implement Vivo, a genAI-powered clinical trial control tower, for INmune's global Phase 2 Alzheimer's disease trial. The AD02 trial has completed patient randomization with 208 participants, comprising 56% mild AD and 44% mild cognitive impairment patients.
Vivo unifies data from multiple sources including EDC, CTMS, PROs/COAs, labs, and safety databases, providing real-time insights for improved decision-making. Initial benefits include enhanced data quality through automatic discrepancy identification, improved COA visualization, and real-time decision support for patient enrollment. Top-line cognitive results are expected in Q2 2025.
INmune Bio (NASDAQ: INMB) e OmniScience hanno stretto una partnership per implementare Vivo, una torre di controllo per studi clinici potenziata da genAI, per lo studio globale di Fase 2 sull'Alzheimer di INmune. Lo studio AD02 ha completato la randomizzazione dei pazienti con 208 partecipanti, di cui il 56% affetti da lieve Alzheimer e il 44% con lieve deterioramento cognitivo.
Vivo unifica i dati provenienti da più fonti, inclusi EDC, CTMS, PRO/COA, laboratori e database di sicurezza, fornendo informazioni in tempo reale per decisioni migliori. I benefici iniziali includono una qualità dei dati migliorata grazie all'identificazione automatica delle discrepanze, una visualizzazione migliore dei COA e supporto decisionale in tempo reale per l'arruolamento dei pazienti. I risultati cognitivo principali sono attesi nel secondo trimestre del 2025.
INmune Bio (NASDAQ: INMB) y OmniScience se han asociado para implementar Vivo, una torre de control de ensayos clínicos impulsada por genAI, para el ensayo global de Fase 2 sobre la enfermedad de Alzheimer de INmune. El ensayo AD02 ha completado la aleatorización de pacientes con 208 participantes, que consisten en un 56% de pacientes con Alzheimer leve y un 44% con deterioro cognitivo leve.
Vivo unifica datos de múltiples fuentes, incluyendo EDC, CTMS, PROs/COAs, laboratorios y bases de datos de seguridad, proporcionando información en tiempo real para una mejor toma de decisiones. Los beneficios iniciales incluyen una mejor calidad de datos a través de la identificación automática de discrepancias, una mejora en la visualización de COA y apoyo en tiempo real para la inclusión de pacientes. Se esperan resultados cognitivos preliminares en el segundo trimestre de 2025.
INmune Bio (NASDAQ: INMB)와 OmniScience는 INmune의 글로벌 2상 알츠하이머병 임상 시험을 위해 genAI로 구동되는 Vivo라는 임상 시험 관제탑을 구현하기 위해 파트너십을 체결했습니다. AD02 시험은 208명의 참가자가 있는 환자 무작위 배정을 완료했으며, 이 중 56%는 경증 알츠하이머 환자이고 44%는 경증 인지 장애 환자입니다.
Vivo는 EDC, CTMS, PROs/COAs, 실험실 및 안전 데이터베이스를 포함한 여러 출처의 데이터를 통합하여 개선된 의사 결정을 위한 실시간 통찰력을 제공합니다. 초기 이점으로는 자동 불일치 식별을 통한 데이터 품질 향상, COA 시각화 개선, 환자 모집을 위한 실시간 의사 결정 지원이 포함됩니다. 주요 인지 결과는 2025년 2분기에 발표될 예정입니다.
INmune Bio (NASDAQ: INMB) et OmniScience se sont associés pour mettre en œuvre Vivo, une tour de contrôle des essais cliniques alimentée par genAI, pour l'essai mondial de Phase 2 sur la maladie d'Alzheimer d'INmune. L'essai AD02 a complété la randomisation des patients avec 208 participants, comprenant 56% de patients atteints de la maladie d'Alzheimer légère et 44% de patients présentant un léger trouble cognitif.
Vivo unifie les données provenant de plusieurs sources, y compris EDC, CTMS, PROs/COAs, laboratoires et bases de données sur la sécurité, fournissant des informations en temps réel pour une meilleure prise de décision. Parmi les premiers avantages, citons une qualité des données améliorée grâce à l'identification automatique des incohérences, une meilleure visualisation des COA et un soutien à la décision en temps réel pour le recrutement des patients. Les résultats cognitifs principaux sont attendus au deuxième trimestre 2025.
INmune Bio (NASDAQ: INMB) und OmniScience haben eine Partnerschaft geschlossen, um Vivo, einen von genAI unterstützten klinischen Studienkontrollturm, für die globale Phase-2-Studie von INmune zur Alzheimer-Krankheit umzusetzen. Die AD02-Studie hat die Randomisierung der Patienten mit 208 Teilnehmern abgeschlossen, darunter 56 % mit leichter Alzheimer und 44 % mit leichter kognitiver Beeinträchtigung.
Vivo vereint Daten aus mehreren Quellen, darunter EDC, CTMS, PROs/COAs, Labore und Sicherheitsdatenbanken, und bietet Echtzeiteinblicke zur Verbesserung der Entscheidungsfindung. Zu den ersten Vorteilen gehören eine verbesserte Datenqualität durch automatische Identifizierung von Unstimmigkeiten, eine verbesserte COA-Visualisierung und Unterstützung bei der Entscheidungsfindung in Echtzeit für die Patientenrekrutierung. Die wichtigen kognitiven Ergebnisse werden im 2. Quartal 2025 erwartet.
- Successfully completed patient randomization for Phase 2 Alzheimer's trial with overenrollment (208 patients)
- Implementation of advanced genAI technology for improved clinical trial efficiency
- Clear timeline for top-line cognitive results (Q2 2025)
- None.
Insights
This partnership introduces a significant technological advancement in clinical trial management for INmune Bio's Phase 2 Alzheimer's trial. The implementation of Vivo, a genAI-powered platform, represents a substantial improvement in data analysis capabilities for the 208-patient AD02 trial.
The platform's ability to unify and analyze multiple data streams in real-time could potentially reduce trial analysis time and improve data quality. Key operational benefits include automated discrepancy identification, enhanced visualization of clinical outcome assessments and real-time decision support for patient enrollment. With top-line cognitive results expected in Q2 2025, this technology could accelerate the analysis phase and potentially provide more comprehensive insights.
The trial's patient composition of
The Vivo platform represents a significant technological leap in clinical trial management, leveraging generative AI to create a comprehensive "control tower" for real-time data analysis. The system's architecture, which integrates multiple data sources (EDC, CTMS, PROs/COAs, labs, sensors) through a unified platform, addresses a critical industry need for streamlined data management.
The platform's emphasis on explainability and interpretability is particularly noteworthy, as it ensures transparency in AI-generated insights - a important feature for regulatory compliance in clinical trials. The cognitive architecture's combination of ontological knowledge with domain expertise enables both qualitative and quantitative analysis at scale, potentially reducing analysis time and improving decision-making accuracy.
Vivo Empowers Clinical Development Teams to Accelerate Decision-making and Analyses in Clinical Trials for Improved Outcomes
HOUSTON and BOCA RATON, Fla., Dec. 04, 2024 (GLOBE NEWSWIRE) -- OmniScience and INmune Bio (NASDAQ: INMB) today announced a pioneering partnership to revolutionize operations for INmune Bio’s global Phase 2 Alzheimer’s disease (AD) clinical trial (the “AD02 trial”) using OmniScience’s flagship product, Vivo, an industry-first, genAI-powered control tower designed specifically for centralizing and analyzing vast clinical data in real time. This solution represents a innovative approach to clinical research, delivering immediate insights that enhance decision-making and transform traditional, time-consuming trial management.
Vivo securely unifies data across sources including electronic data capture (EDC), clinical trial management systems (CTMS), patient-reported outcomes (PROs)/clinical outcome assessments (COAs), labs, sensors/wearables, safety databases, and more. With fully integrated data, Vivo goes beyond dashboard visualizations to enable clinical trial teams to improve their decision-making, accelerate timelines, enhance patient safety, and ultimately improve health outcomes. Designed with explainability and interpretability at its core, Vivo ensures that every generated insight is supported by clear, traceable rationale grounded in data and clinical context. Its advanced cognitive architecture combines ontological knowledge of trial protocols with domain-specific clinical expertise, enabling qualitative and quantitative reasoning at scale.
INmune Bio recently announced it completed randomization of patients for its blinded AD02 trial for patients with early AD and biomarkers of elevated neuroinflammation. The trial overenrolled with a total of 208 patients,
“A global trial of this size is vast, and Vivo will be critical in our ability to analyze cognitive results,” stated Tara Lehner, INmune Bio’s VP of Clinical Operations. “With genAI provided by Vivo, we can amplify our clinical teams’ capabilities, turning complex data into actionable insights at unprecedented speed, which means we can get answers—and treatments—to patients faster.”
INmune and OmniScience partnered throughout Vivo’s product development and have completed the first phase of Vivo’s roll-out to INmune’s clinical development team. Throughout the initial rollout, significant beneficial findings include:
- Improved data quality through Vivo’s automatic identification of data discrepancies
- Enhanced visualization of COAs, supporting identification of outliers and better understanding of population distributions
- Real-time answers, supporting decisions on patient enrollment criteria, even while the patient is in the clinic
- Reduced reliance on time-consuming spreadsheet-based data analysis, improving collaboration between clinical and executive teams
“OmniScience and INmune Bio share a vision to transform how clinical trial teams engage with data – transforming data into knowledge in real time and informing decisions that increase the probability of success,” shared Angela Holmes, CEO of OmniScience. “As our partnership moves forward, we’re gaining further insights from the INmune team that we can integrate into Vivo’s roadmap. We look forward to our continued mutual success.”
“The future of clinical trials demands smarter solutions, and Vivo embodies this shift,” explained Michael Bell, VP of Product, OmniScience. “Through this collaboration, INmune Bio provides continuous feedback that enables OmniScience’s development team to evolve Vivo. This hands-on approach builds confidence among users, who see firsthand how genAI can rapidly turn data into answers and transform their day-to-day workflows.”
About OmniScience Inc.
OmniScience is a trusted partner to leading life science organizations, advancing clinical R&D missions through unparalleled expertise in clinical data science. We believe in a future where all clinical trial data can be unified and translated into knowledge in real time.
Our expert team has created Vivo, the first and only company in the world to enable GenAI as a control tower, offering on demand insights into live unified clinical trial data. No spreadsheets, no SQL queries, no emails. Vivo revolutionizes the way pharma manages clinical trials and employs generative AI, with the industry's first gen AI assistant for clinical trial operations. Vivo is more than just a platform – it’s your new favorite clinical development colleague, poised to transform clinical trial operation teams’ day-to-day workflow and ability to optimize trial insights with generative AI. Vivo was recently awarded top honors at the Innovation Showcase at the November 2024 CNS Summit as well as the 2024 Innovation Network Gathering Whale Tank competition.
To discuss how OmniScience can support your clinical trials, please visit www.omniscience.bio or reach us at hello@omniscience.bio or on LinkedIn.
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.
For OmniScience:
Media Contact:
Sean Leous
ICR Healthcare
Sean.leous@icrhealthcare.com
646-866-4012
For INmune Bio Inc.:
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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