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Alto Neuroscience declares positive ALTO-101 Phase I trial results

Alto Neuroscience has reported positive results from its Phase I trial of ALTO-101, a PDE4 inhibitor for treating cognitive impairment in schizophrenia (CIAS). The study found that administering ALTO-101 via a transdermal delivery system (TDS) improved tolerability and pharmacokinetics compared to oral intake.

The Phase I trial aimed to assess the safety, tolerability, pharmacokinetics, and adhesion properties of ALTO-101's transdermal formulation versus oral administration in healthy volunteers. Fifteen participants aged 40 to 64 underwent a two-way crossover design with two dosing periods.

The first period involved a single oral dose of 1mg ALTO-101, followed by a seven-day washout. In the second period, participants received an 18mg transdermal dose for two days. Transdermal ALTO-101 resulted in significantly higher and more consistent drug concentrations than oral intake, with fewer class-related adverse events.

These findings suggest ALTO-101 has the potential for CIAS treatment, addressing an unmet need in this condition.