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Unlearn and Trace Neuroscience Partner to Optimize ALS Clinical Trial

Published a day ago via Business Wire

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, today 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.

“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.

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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About Trace Neuroscience

Trace Neuroscience is a biopharmaceutical company on a mission to expand the promise of genomic medicine for people living with neurodegenerative diseases. With an initial focus on ALS, the company is developing novel therapies to restore UNC13A protein function to re-establish healthy communication between nerves and muscle cells. Trace Neuroscience launched in 2024 with $101M in Series A funding led by Third Rock Ventures and is headquartered in South San Francisco, CA. Learn more at www.traceneuro.com.

About Unlearn

Unlearn (www.unlearn.ai) partners with pharma and biotech companies to design and optimize clinical trials using AI-powered digital twins. By forecasting patients’ clinical outcomes, Unlearn helps sponsors refine trial design, shorten timelines, and increase the chance of detecting treatment effects in less time. With a science-first approach and deep regulatory engagement—including EMA qualification and FDA endorsement—Unlearn is transforming clinical development to be faster, smarter, and more reliable.

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