Collaboration will support trial planning for Trace Neuroscience’s upcoming Phase 1/2 clinical trial in ALS

Unlearn, a leader in AI-powered solutions for clinical trials, announced a collaboration with Trace Neuroscience, a biotechnology company focused on developing genomic therapies for neurodegenerative diseases. The partnership will support Trace Neuroscience as the company plans its upcoming Phase 1/2 clinical trial in amyotrophic lateral sclerosis (ALS), using Unlearn’s Digital Twin Generator for ALS (ALS DTG) and the Unlearn Platform.

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“Trace Neuroscience is advancing its development program targeting the UNC13A protein, a genetic target directly linked to ALS progression, and we’re proud to support their mission by helping lay the foundation for more efficient trials and faster paths to potential treatments,” said Steve Herne, CEO of Unlearn.

Through the partnership, Trace Neuroscience will leverage Unlearn’s ALS DTG, a proprietary machine-learning model trained on more than 13,000 longitudinal clinical records from sources including APST, PRO-ACT, and NEALS. DTGs forecast how individual patients are likely to progress under standard of care or in the placebo group of a clinical trial, creating a “digital twin” for each trial participant based on their baseline data.

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Unlearn’s ALS DTG is a powerful tool to simulate disease progression, assess the relationship between disease status at baseline, clinical endpoints, and biomarkers over time, and enables partner companies to take actionable steps to optimize their clinical programs. Trace Neuroscience will utilize the ALS DTG to inform protocol decisions, such as specific inclusion and exclusion criteria and endpoint strategies, with the goal of increasing trial power and confidence in detecting both clinical and biomarker-based efficacy signals.

“This collaboration brings together two powerful approaches—AI and genomic medicine—to rethink how ALS trials are designed,” said Eric Green, M.D., Ph.D., co-founder and CEO of Trace Neuroscience. “Working with Unlearn to mine their extensive, well-curated database through the use of the ALS DTG will enable us to explore smarter designs and make confident and informed decisions as we plan our Phase 1/2 trial. Ultimately, these insights can help us to move faster for people living with ALS who are waiting for new treatment options.”

This partnership reflects both companies’ commitment to bringing scientifically rigorous, innovative therapies to the ALS community with greater speed and confidence. Unlearn and Trace Neuroscience also plan to co-author scientific publications emerging from this work.

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Source – businesswire