Phesi, a leading clinical development analytics company, has published new research in the journal Bone Marrow Transplantation (BMT-Nature). The study demonstrates that AI-powered digital twins solutions can potentially replace the standard-of-care (SOC) control arm of a clinical trial, and is co-authored by Dr Yi-Bin Chen, Director for the Blood and Marrow Transplant Program at Massachusetts General Hospital. 

Phesi Develops Digital Twin for cGvHD Treatment

What Is cGvHD?

Chronic graft-versus-host disease (cGvHD) is a significant complication following allogeneic hematopoietic cell transplantation (HCT).

The Digital Twin Approach:

• Phesi created a digital twin to simulate cGvHD patients undergoing prednisone treatment.
• Prednisone is the current first-line standard of care for cGvHD and serves as a common control in clinical trials.

Data Source:

• Phesi’s Trial Accelerator platform provided real-world data.
• Over 108 million patients across nearly 367,000 cohorts contributed to the digital twin development.
• Specifically, 2,042 cGvHD patients from 32 cohorts formed the first-line therapy (flGvHD) digital twin cohort.
• An additional 438 patients from 8 cohorts were used for the flGvHD digital twin standard-of-care cohort.

Dr. Gen Li’s Insights:

• Dr. Gen Li, President of Phesi, emphasized the potential of digital twins:
  • Addressing patient recruitment challenges.
  • Mitigating ethical concerns related to placebo arms.
  • Streamlining clinical trial duration and approval processes.
  • Replacing standard-of-care comparator arms effectively.

Digital twins hold promise in revolutionizing clinical trials and improving patient outcomes. 🌟👩‍⚕️🔬

New Phesi proof of concept demonstrates potential of AI-powered digital twins

Research indicates that digital twins may benefit clinical trials for a range of diseases beyond cGvHD. The goal is to gain regulatory approval for this approach, making it a fundamental aspect of clinical trial planning and implementation. Phesi is looking forward to working with regulatory bodies such as the FDA to advance the application of digital twin technology in clinical research.

Current research shows that annually, over 50,000 cancer patients worldwide undergo HCT. Among them, 30-50% develop cGvHD, which significantly impairs their long-term quality of life. Despite corticosteroids being the primary

The cGvHD digital twin is the latest in Phesi’s series of published digital twins for clinical development. These include a digital twin for non-small cell lung cancer (NSCLC) KRAS G12C patients, and a digital twin for CAR-T Cytokine Release Syndrome (CRS) patients.