By Steve Herne, CEO of Unlearn

One of the most rewarding parts of my role is working alongside teams excited about using AI to make clinical development more efficient and, ultimately, better for patients. This quarter, I’m especially proud of how we brought that vision to life, advancing the real-world use of AI-generated digital twins in clinical trials through bold collaboration. We also received positive feedback from the FDA supporting an upcoming Phase 2b/3 study expected to launch at the end of Q2, signaling confidence in our approach as we prepare to scale its impact.

While our recent work has focused on neurodegenerative diseases, we’re excited to be expanding into new therapeutic areas. Stay tuned for more on that soon.

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Q2 Conference Highlights 

• At AD/PD Vienna, AbbVie shared a retrospective analysis of the Alzheimer’s disease Tilavonemab trial showing that digital twins could reduce sample size by 13% and placebo arm size by 23%, demonstrating how variance reduction leads to more precise treatment effect estimates and faster, more efficient trials.
  
  • We also presented research in Parkinson’s disease showing how digital twins can reduce the control arm size by 38% for the same endpoint, allowing more patients to be randomized to the treatment arm.
• At the ALS Drug Development Summit, we co-presented with ProJenX, to share how digital twins are being used as simulated controls in their open-label Phase 1 trials, enhancing confidence in early signals, supporting subgroup exploration, and informing Phase 2 endpoint selection. 
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• At ENCALS, we demonstrated how digital twins can sharpen the prognostic value of NfL, enabling more patients to receive the investigational treatment.

“This variance reduction (with digital twins) could have had a significant impact on the number of subjects we needed…and still preserved the same power…we would have had a faster enrollment, encourage(d) greater patient participation. And ultimately, that would have been cost-saving and time-saving.”

— Ole Graff, Executive Medical Director, Neuroscience Development, AbbVie

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AI That Meets the Moment

In June, Forbes featured Unlearn in a piece exploring how AI-generated digital twins are poised to reshape the future of clinical trials. As Unlearn’s co-founder, Aaron Smith, noted: “Digital twins are powerful tools to understand disease progression and answer key clinical research questions – one of the most important being how to make clinical trials more efficient.”

Aaron and our other co-founder, Jon Walsh, also published a whitepaper detailing how our approach using digital twins to boost trial power aligns with the FDA’s proposed 7-step risk-based framework for AI in clinical development.

‍Partnering for Impact 

We announced a new partnership with Trace Neuroscience, a company developing genomic therapies for ALS. As they plan their upcoming Phase 1/2 trial targeting a key genetic driver of ALS progression, Trace Neuroscience will use digital twins to simulate disease trajectories, test protocol strategies, and design a smarter, more efficient study.
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“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. 

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We also announced a new collaboration with remynd, a biotech developing treatments for Alzheimer’s disease. In their Phase 2a trial of REM127, digital twins served as individualized comparators, strengthening evidence by helping interpret changes in biomarkers and treatment effects.
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As Gerard Griffioen, Ph.D., CSO of remynd, shared: “Digital twins offer a new lens for interpreting biomarker trends over time—especially in early-stage trials where every data point matters.” ‍

Growing our Leadership

Finally, we made a critical investment in Unlearn’s future by welcoming Krates Ng as our new Chief Technology Officer. With deep experience building and scaling enterprise software systems, Krates’ leadership will ensure our AI solutions remain robust, scalable, and trusted by the world’s leading sponsors.

There’s more to come, but if you want to see what’s already possible today, I encourage you to visit our website’s Evidence page. It’s where you’ll find real data, from real trials, showing how digital twins are changing the game.