On Thursday, Baird reaffirmed its Outperform rating on Alto Neuroscience (NYSE:ANRO), with a steady stock price target of $32.00. The endorsement follows the commencement of Alto's Phase 2 trial for ALTO-101 in Cognitive Impairment Associated with Schizophrenia (CIAS), noted for building upon the favorable tolerability profile recognized earlier this year for its transdermal formulation.
Alto Neuroscience has initiated the Phase 2 study of ALTO-101, a drug aimed at treating CIAS. The company's transdermal delivery method has been highlighted for its ability to achieve high levels of drug exposure without the adverse effects (AEs) that have deterred other PDE4 inhibitor developers. This strategic approach is expected to be a key factor in the drug's development and future success.
The rapid progression to a Phase 2 trial underscores Alto's proficiency in clinical execution. The trial's primary endpoint will focus on EEG theta band activity, a measure of cognitive function. Positive results from this trial are anticipated in the second half of 2025, as per the company's projections.
Alto Neuroscience's move to a Phase 2 trial represents a significant step in the clinical development of ALTO-101. The company's choice of a transdermal application method is designed to circumvent the adverse effects commonly associated with PDE4 inhibitors, thereby potentially offering a more tolerable treatment option for CIAS.
The company's clinical execution capabilities have been recognized as a strong point, with expectations set for a favorable impact on the primary endpoint of the Phase 2 trial. This could mark a pivotal development for Alto Neuroscience in its pursuit of a novel treatment for CIAS, with the trial's outcomes eagerly awaited in the latter half of 2025.
In other recent news, Alto Neuroscience has been making significant strides in its research and development. The company recently appointed Michael Hanley, a seasoned professional in the life sciences industry, as its new Chief Operating Officer. Hanley is expected to drive Alto's product planning and portfolio strategy, particularly in the central nervous system and neuroscience sectors.
Alto Neuroscience also reported positive Phase 1 results for ALTO-101, a novel transdermal PDE4 inhibitor. The study showed favorable tolerability and pharmacokinetics, suggesting potential benefits for treating cognitive impairment associated with schizophrenia. The company plans to initiate a proof-of-concept study for ALTO-101 in the first half of 2024, with topline data expected in the second half of 2025.
Furthermore, Alto Neuroscience has launched a Phase 2 clinical study to evaluate the effects and safety profile of its drug candidate ALTO-203 in patients with major depressive disorder. The drug has shown promise in Phase 1 trials, and the current double-blind, placebo-controlled trial will involve two sequential treatment periods to evaluate both the acute and long-term effects of ALTO-203.
Topline data from this study is expected to be reported in the first half of 2025. These are the latest developments in Alto Neuroscience's ongoing efforts to provide targeted treatments for mental health conditions.
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