Positive Results for Alto Neuroscience in Phase 1 Schizophrenia Study

Alto Neuroscience, Inc. (NYSE: ANRO) has announced positive results from its Phase 1 study of ALTO-101 for cognitive impairment associated with schizophrenia (CIAS). The study demonstrated favorable tolerability and improved pharmacokinetics of ALTO-101 when administered via a transdermal delivery system (TDS) compared to oral administration. Alto ended the day up 1.76% and rose a further 0.29% after market on Tuesday.

ALTO-101 delivered transdermally resulted in significantly higher, and consistent, drug concentrations compared to oral administration, and substantially lower class-related adverse events typically associated with PDE4 inhibitors.

With these results in hand, the company plans to initiate a proof-of-concept study evaluating ALTO-101 in patients with CIAS in the first half of 2024, with topline data expected in the second half of 2025.

Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience, said, “These positive results provide a strong indication that ALTO-101 could become an important therapeutic option for a broad range of indications,”

Dr. Etkin stated that oral PDE4 inhibitors are associated with burdensome and dose-limiting side effects and despite dosing and tolerability challenges, PDE4 inhibitors are used widely in other non-CNS indications, often with sub-optimal dosing regimens.

“We have now demonstrated transdermal administration of ALTO-101 results in significantly greater, stable drug concentration with a once-daily formulation that is well-tolerated. We believe the reduction in typical class-wide adverse events observed with ALTO-101 provides a significant point of differentiation compared to other PDE4 inhibitors currently available, or in development. We look forward to advancing this product candidate for patients with CIAS who currently have few treatment options.”

The TDS formulation is being developed in partnership with MEDRx. The drug exposure levels achieved with the transdermal formulation were significantly greater than systemic exposure with oral administration while also reducing typical class-wide adverse events.

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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Positive Results for Alto Neuroscience in Phase 1 Schizophrenia Study

Catie Corcoran

Biotech Editor