Alto Neuroscience identifies biomarker for ALTO-203 in depression study

Published 26/06/2025, 12:44
Alto Neuroscience identifies biomarker for ALTO-203 in depression study

MOUNTAIN VIEW, Calif. - Alto Neuroscience, Inc. (NYSE:ANRO), a clinical-stage biopharmaceutical company with a market capitalization of $68 million, has identified a patient selection biomarker in its exploratory Phase 2 proof-of-concept trial of ALTO-203 in major depressive disorder patients with elevated anhedonia levels, according to a company press release. InvestingPro data shows the company maintains a strong liquidity position with a current ratio of 22.5, indicating robust short-term financial stability.

ALTO-203, an oral histamine H3 inverse agonist, demonstrated effects on attention and wakefulness linked to changes in EEG theta/beta ratio, a biomarker for cortical arousal and attentional control. These findings replicate results from the company’s earlier Phase 1 study in healthy volunteers.

The exploratory trial enrolled 69 patients in a double-blind, placebo-controlled design across two sequential periods. Patients receiving ALTO-203 showed significant improvements in sustained attention compared to placebo, with the 25µg dose achieving statistical significance (p

"We identified a robust biomarker for ALTO-203, EEG high-theta/beta ratio, which is a well-validated measure of abnormal cortical arousal and poor attentional control," said Amit Etkin, founder and CEO of Alto Neuroscience.

Wearable device data confirmed the wake-promoting effects of ALTO-203, with significant increases in wakefulness at both the 25µg (p

On the Montgomery-Åsberg Depression Rating Scale (MADRS), patients taking the 25µg dose showed mean improvements of 2 points at week 3 and 0.9 points at week 4 compared to placebo, though the study was not powered to detect statistical significance on traditional depression scales.

Alto Neuroscience plans to report additional results at a future medical meeting and will determine next development steps following complete analysis of the data. The company’s next earnings report is scheduled for August 19, 2025, with analyst price targets ranging from $4 to $18 per share. While the stock has faced challenges, declining 74% over the past year, InvestingPro subscribers have access to 8 additional key insights about Alto Neuroscience’s financial health and growth prospects. Discover more detailed analysis and real-time updates with an InvestingPro subscription.

In other recent news, Alto Neuroscience has announced the acquisition of ALTO-207, previously known as CTC-501, from Chase Therapeutics Corporation. This acquisition is part of Alto’s strategic efforts to strengthen its clinical pipeline, particularly in addressing treatment-resistant depression (TRD). ALTO-207 is a combination of pramipexole and ondansetron, which has shown promising results in Phase 2a trials, meeting both primary and secondary endpoints. The company plans to initiate a Phase 2b trial for this drug by mid-2026, with topline data expected in 2027.

In addition, Alto has acquired CTC-413, now ALTO-208, aimed at treating Parkinson’s disease, with an upfront payment of $1.75 million and potential milestone payments up to $71.5 million. H.C. Wainwright has maintained its Buy rating on Alto Neuroscience, setting a price target of $10, reflecting confidence in the company’s strategic direction and potential impact of ALTO-207. Furthermore, Alto reported progress in its trials for ALTO-300, a drug for major depressive disorder (MDD), showing a favorable tolerability profile in recent studies. The ongoing Phase 2b trial for ALTO-300 has not reported any significant liver enzyme elevations, indicating a balance of efficacy and safety.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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