Alto Neuroscience Advances Four Phase 2 Trials With Precision Psychiatry Focus

Alto Neuroscience is rapidly expanding its clinical pipeline with four ongoing phase 2 trials, all incorporating precision psychiatry approaches to target unmet needs in psychiatric treatment, Amit Etkin, MD, PhD, founder and CEO of Alto Neuroscience, told Psychiatric Times in a recent interview. Alto presented data at the Society of Biological Psychiatry Annual Meeting in Toronto, Canada.¹

In discussing the promise that biomarkers hold for advances in precision psychiatry, Etkin said “There’s a lot of opportunity here for finding new drugs for different populations and drugs for populations for which there are no treatments at all.”

Etkin explained 2 of the current Alto studies are late-stage phase 2B studies while the other 2 are earlier phase 2 trials. All 4 trials include some form of patient stratification using biomarkers or other measures to optimize treatment matching, Etkin told Psychiatric Times. “There’ll be both tests of new drugs for high-need populations, but also a test of precision psychiatry,” he explained.

Etkin sees this as part of a broader transformation in the field: “My hope is in the next 2 years, we’ll really be at a point that is an inflection point in the history of our field, where we’re now much more targeted in terms of how we develop drugs and really understand for whom things work and why,” he told Psychiatric Times.

In addition to studies in major depressive, Alto is also looking at unmet needs in schizophrenia, like cognition—a domain where current treatment options are virtually nonexistent.

For those interested in learning more, Etkin encouraged clinicians and researchers to visit the company’s website, which hosts scientific posters, publications, and recorded presentations from investor and academic meetings.²

“There’s a lot of excitement here at Alto and frankly, a lot of potential for a field that, as a psychiatrist, I’d love to see changes in soon,” Etkin told Psychiatric Times.

This is the final installment of a 3-part series discussing the new research. Dr Etkin discussed issues in identifying the placebo response in the first segment and the implications for understanding MDD treatment with Alto 300 in the second segment.

References

1. Alto Neuroscience Presents New Data at the Society of Biological Psychiatry Annual Meeting Underscoring Precision Psychiatry Approach. Press release. April 28, 2025. Accessed May 15, 2025. https://investors.altoneuroscience.com/news/news-details/2025/Alto-Neuroscience-Presents-New-Data-at-the-Society-of-Biological-Psychiatry-Annual-Meeting-Underscoring-Precision-Psychiatry-Approach/default.aspx

2. Leveraging clinical and biological insights to drive innovation in psychiatry. Accessed May 15, 2025. https://altoneuroscience.com/platform/publications/