Alto Neuroscience to Launch Phase 2b Trial of ALTO-207 for Treatment Resistant Depression by 2026
Reuters
Oct 20, 2025
Alto Neuroscience to Launch Phase 2b Trial of ALTO-207 for Treatment Resistant Depression by 2026
Alto Neuroscience Inc. announced plans to accelerate the development of ALTO-207 for treatment-resistant depression following a successful outcome from a recent FDA meeting. The company intends to initiate a Phase 2b, potentially pivotal, clinical trial of ALTO-207 by mid-2026, and a Phase 3 clinical trial by early 2027, pending alignment with the FDA and completion of Phase 3 readiness activities. The advancement is supported by a $50 million private placement. Additionally, Alto provided an update on its pipeline, including positive blinded pharmacokinetic $(PK)$ analysis results from ongoing Phase 2 studies of ALTO-100 in bipolar depression and ALTO-101 in cognitive impairment associated with schizophrenia $(CIAS)$. The company also announced that topline data from the Phase 2 study of ALTO-101 in CIAS are expected to be reported in the first quarter of 2026. Results from current studies have not yet been presented and are anticipated in the future.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Alto Neuroscience Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251020895285) on October 20, 2025, and is solely responsible for the information contained therein.
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