Alto Neuroscience announces positive Phase I trial results for ALTO-101, a PDE4 inhibitor, in the treatment of cognitive impairment associated with schizophrenia (CIAS). The transdermal formulation shows improved pharmacokinetics and tolerability compared to oral administration, offering a potential therapeutic option with stable drug concentrations. These findings address the unmet need for targeted treatments for CIAS and pave the way for further development of ALTO-101.
ALTO-101: A Promising Treatment for Cognitive Impairment Associated with Schizophrenia
( Credit to: Clinicaltrialsarena )
Alto Neuroscience has announced positive results from its Phase I clinical trial of ALTO-101, a PDE4 inhibitor, for the treatment of cognitive impairment associated with schizophrenia (CIAS). The study focused on evaluating the safety, tolerability, pharmacokinetics, and adhesion properties of ALTO-101's transdermal formulation in comparison to oral administration in healthy volunteers.
The results of the study revealed that the transdermal administration of ALTO-101 exhibited improved pharmacokinetics compared to oral administration. The transdermal delivery system led to significantly higher and more consistent drug concentrations, indicating better drug exposure levels within the therapeutic range. Additionally, the transdermal formulation resulted in lower rates of adverse events typically associated with PDE4 inhibitors.
These findings are promising as they suggest that ALTO-101 could potentially be a valuable therapeutic option for a wide range of indications. Current oral PDE4 inhibitors have demonstrated cognitive benefits but come with burdensome side effects and dose limitations. The transdermal administration of ALTO-101 offers a once-daily formulation that is well-tolerated and provides stable drug concentrations.
Positive Phase I Trial Results for ALTO-101's Transdermal Formulation
Fifteen participants between the ages of 40 and 64 were enrolled in the study, which utilized a two-way crossover design with two dosing periods. In the first period, participants received a single oral dose of 1mg ALTO-101, followed by a seven-day washout period. In the second period, participants were administered an 18mg transdermal dose of ALTO-101 for two days.
The results of the study revealed that the transdermal administration of ALTO-101 exhibited improved pharmacokinetics compared to oral administration. The transdermal delivery system led to significantly higher and more consistent drug concentrations, indicating better drug exposure levels within the therapeutic range. Additionally, the transdermal formulation resulted in lower rates of adverse events typically associated with PDE4 inhibitors.
These findings are promising as they suggest that ALTO-101 could potentially be a valuable therapeutic option for a wide range of indications. Current oral PDE4 inhibitors have demonstrated cognitive benefits but come with burdensome side effects and dose limitations. The transdermal administration of ALTO-101 offers a once-daily formulation that is well-tolerated and provides stable drug concentrations.
Addressing the Unmet Need for Targeted Treatments for CIAS
Amit Etkin, the founder and CEO of Alto Neuroscience, expressed optimism about the positive results, stating that ALTO-101 could address the unmet need for targeted treatments for CIAS. Patients with CIAS currently have limited treatment options available, making the development of ALTO-101 an important advancement in the field.
ALTO-101: A Potential Treatment Option for Cognitive Impairment Associated with Schizophrenia
Overall, the Phase I trial results for ALTO-101's transdermal formulation are encouraging, showing improved pharmacokinetics and tolerability compared to oral administration. The positive outcomes pave the way for further development of ALTO-101 as a potential treatment option for cognitive impairment associated with schizophrenia.