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Alto Neuroscience Reports Topline Data from Phase 2 Study
Company to focus on lead program ALTO-207, explore partnering opportunities for ALTO-101
Apr. 2, 2026 at 7:23am
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Alto Neuroscience announced topline data from its Phase 2 proof-of-concept study evaluating ALTO-101 for the treatment of cognitive impairment associated with schizophrenia. While ALTO-101 did not meet the primary endpoint, the study demonstrated directional improvements across certain EEG measures. The company has developed a modified-release oral formulation of ALTO-101 and plans to explore partnering opportunities, while prioritizing resources toward its lead program, ALTO-207, for treatment-resistant depression.
Why it matters
The results highlight the challenges of developing effective treatments for cognitive impairment in schizophrenia, an area of high unmet need. Alto's decision to focus on its lead program ALTO-207 reflects the company's strategic prioritization of its most advanced and promising asset, which has shown strong prior clinical data and external validation.
The details
In the proof-of-concept study, ALTO-101 did not achieve statistical significance on the primary EEG or cognitive endpoints versus placebo. However, the study demonstrated directional improvements across certain EEG measures, including a near-significant effect on theta-ITC, a measure correlated with cognitive performance. In a pre-specified analysis of a more cognitively impaired subgroup, ALTO-101 exhibited nominally significant effects on theta-ITC compared to placebo. The company has also developed a modified-release oral formulation of ALTO-101 with an improved pharmacokinetic and tolerability profile, which it plans to explore partnering opportunities for.
- The Phase 2b trial for ALTO-207 is on track to initiate in the first half of 2026.
The players
Alto Neuroscience
A clinical-stage biopharmaceutical company focused on precision medicines for neuropsychiatric disorders.
Amit Etkin, M.D., Ph.D.
Founder and chief executive officer of Alto Neuroscience.
What they’re saying
“While we are disappointed that the ALTO-101 data did not deliver the signal we were seeking, it is an exploratory program, and we remain heavily focused on ALTO-207, our most advanced program in development for treatment -resistant depression – which is supported by strong prior clinical data and external validation.”
— Amit Etkin, Founder and chief executive officer of Alto Neuroscience
What’s next
The company does not plan to independently advance ALTO-101 in cognitive impairment associated with schizophrenia and will instead prioritize resources toward its lead program, ALTO-207, while exploring strategic partnering opportunities for ALTO-101.
The takeaway
Alto's decision to focus on its lead program ALTO-207 for treatment-resistant depression, which has shown strong prior clinical data and external validation, reflects the company's strategic prioritization of its most promising asset as it navigates the challenges of developing effective treatments for cognitive impairment in schizophrenia.
