Alto Neuroscience Initiates Study of Transdermal Treatment for Schizophrenia

Alto Neuroscience (NYSE: ANRO) has initiated a Phase 2 double-blind, placebo-controlled study of a transdermal formulation of ALTO-101 for the treatment of cognitive impairment associated with schizophrenia (CIAS). The study is Alto’s sixth Phase 2 study across its pipeline programs.

Alto’s cross-over double-blind, placebo-controlled, dose-escalating study will enroll approximately 70 adult participants with schizophrenia and a demonstrable level of cognitive impairment. Alto will evaluate the effects of ALTO-101 on EEG markers relevant to cognitive function and will also explore its effects on cognitive performance. Alto expects to report top-line data from the Phase 2 study in the second half of 2025.

Amit Etkin, M.D., Ph.D., founder and CEO of Alto Neuroscience, commented, “Cognitive impairment is disabling in many psychiatric disorders including schizophrenia, depression, and neurodegenerative diseases. ALTO-101 has the potential to address the cognitive aspects of these diseases with a known pro-cognitive mechanism, while also overcoming the side effects typically associated with PDE4 inhibitors. We look forward to completing this proof-of-concept study, as we believe ALTO-101 may benefit patients with CIAS and potentially become an important therapeutic option for a broad range of indications.”

Schizophrenia is a serious, often disabling mental illness that affects approximately 24 million people worldwide, including 2.8 million people in the United States. Around 70% of people with schizophrenia have cognitive impairment associated with the illness, and there are currently no approved treatments to specifically address the negative and cognitive symptoms associated with schizophrenia.

About Alto Neuroscience

Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto’s Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto’s clinical-stage pipeline includes novel drug candidates in depression, PTSD, schizophrenia, and other mental health conditions. For more information, visit www.altoneuroscience.com or follow Alto on X.

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Alto Neuroscience Initiates Study of Transdermal Treatment for Schizophrenia

Catie Corcoran

Biotech Editor