Alto Neuroscience has reported positive results from its Phase I clinical trial of the PDE4 inhibitor, ALTO-101, for treating cognitive impairment associated with schizophrenia (CIAS).
The study demonstrated that ALTO-101, when administered through a transdermal delivery system (TDS), had a favourable tolerability and improved pharmacokinetics compared to oral administration.
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The Phase I study was designed to assess the safety, tolerability, pharmacokinetics, and adhesion properties of ALTO-101’s transdermal formulation, compared to its oral administration, in healthy volunteers.
Alto enrolled 15 participants aged between 40 and 64 in the study, which involved a two-way crossover design, with two dosing periods.
The first period included a single oral dose of 1mg ALTO-101, followed by a seven-day washout period. In the second period, participants received an 18mg transdermal dose of ALTO-101 for two days.
The results indicated that transdermal administrations of ALTO-101 led to significantly higher and more consistent drug concentrations than oral administration.
In addition, the transdermal delivery of ALTO-101 resulted in substantially lower class-related adverse events typically associated with PDE4 inhibitors.
These findings suggest that ALTO-101 has a favourable profile with higher drug exposure levels within the therapeutic range and lower rates of adverse events.
Alto Neuroscience founder and CEO Amit Etkin said: “These positive results provide a strong indication that ALTO-101 could become an important therapeutic option for a broad range of indications.
“Oral PDE4 inhibitors have shown promise as pro-cognitive therapeutics but are associated with burdensome and dose-limiting side effects.
“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 look forward to advancing this product candidate for patients with CIAS who currently have few treatment options.”
ALTO-101 is being developed specifically for CIAS, a condition with no targeted treatments currently available.
Earlier this month, Alto Neuroscience started Phase II clinical trial of histamine H3 receptor inverse agonist, ALTO-203, for treating patients with major depressive disorder (MDD).
