San Francisco – September 27, 2024
ProJenX, a clinical-stage biotech company, has partnered with Unlearn AI to enhance its ALS clinical trial using AI-generated digital twins. The collaboration integrates Unlearn’s ALS-Digital Twin Generator (ALS-DTG) into the Phase I PRO-101 trial of prosetin, an investigational ALS therapy.
These AI-powered digital twins simulate each patient’s disease trajectory, acting as virtual placebos to reduce reliance on traditional control groups. This approach enables more precise comparisons and enhances data quality in early-stage research.
By adopting this model, ProJenX will better assess clinical endpoints like ALSFRS-R, vital capacity, and neurofilament light levels over a 52-week period. The study has already completed early phases in healthy volunteers and is now entering trials with ALS patients, following Health Canada’s regulatory approval.
“By comparing treated patients with their digital placebo counterparts, we gain critical insights that improve the efficiency and precision of our clinical program,” said Stan Abel, President and CEO of ProJenX.
Unlearn’s platform aligns with FDA guidance and is EMA-qualified for Phase 3 trials, signaling growing regulatory support for AI in drug development.
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