INmune Bio and OmniScience are partnering to accelerate INmune Bio’s Phase 2 Alzheimer’s disease (AD) clinical trial (the AD02 trial) using OmniScience’s Vivo, a genAI-powered control tower designed for centralizing and analyzing clinical data in real time.
The collaboration aims to revolutionize clinical trial operations by providing immediate insights, enhancing decision-making, and transforming traditional trial management processes. The AD02 trial is investigating INmune Bio's clinical-stage biotechnology XPro in patients with mild cognitive impairment or Alzheimer’s disease with brain inflammation. The trial has overenrolled with 208 patients diagnosed with mild Alzheimer’s disease or mild cognitive impairment, and top-line results are expected in Q2 2025.
Vivo's Role in Data Analysis
Vivo securely unifies data from various sources, including electronic data capture (EDC), clinical trial management systems (CTMS), patient-reported outcomes (PROs)/clinical outcome assessments (COAs), labs, sensors/wearables, and safety databases. The platform goes beyond dashboard visualizations to enable clinical trial teams to improve decision-making, accelerate timelines, enhance patient safety, and improve health outcomes. Its cognitive architecture combines ontological knowledge of trial protocols with domain-specific clinical expertise, enabling qualitative and quantitative reasoning at scale.
Benefits Observed During Initial Rollout
During the initial rollout of Vivo to INmune Bio’s clinical development team, significant beneficial findings were observed, including:
- Improved data quality through 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.
Expert Perspectives
"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."
Angela Holmes, CEO of OmniScience, shared, "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. 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."
