Positive Phase 1 Results for Alto Neuroscience’s ALTO-101 in Cognitive Impairment Associated with Schizophrenia

Alto Neuroscience’s ALTO-101, a novel PDE4 inhibitor, has demonstrated positive Phase 1 results in healthy subjects, providing hope for a potential new treatment for cognitive impairment associated with schizophrenia (CIAS). The candidate, licensed from Sanofi (SNY), is administered as a transdermal patch through a partnership with MEDRx.

The Phase 1 study compared the tolerability and pharmacokinetics of ALTO-101 administered via a transdermal patch to a pill. Results showed favorable tolerability and improved pharmacokinetics of the patch compared to oral administration. Alto reported that “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.”

Alto plans to initiate a proof-of-concept study evaluating ALTO-101 in patients with CIAS in H1 2024, with top-line data projected in H2 2025. The company’s stock (ANRO) is up approximately 3% in early Tuesday afternoon trading.

Alto Neuroscience is known for its potential first-in-class approach to targeting central nervous system (CNS) disorders. Positive results from this study add to the growing optimism surrounding the company’s pipeline and potential for developing innovative treatments for CNS disorders.

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