Alto Neuroscience to advance depression drug after promising study

MOUNTAIN VIEW, Calif. - Alto Neuroscience, Inc. (NYSE:ANRO), a clinical-stage biotech company with a market capitalization of $62.5 million, plans to initiate a potentially pivotal Phase 2b trial of ALTO-207 for treatment-resistant depression (TRD) by mid-2026, following the publication of promising data in The Lancet Psychiatry. The company’s stock, currently trading at $2.31, has experienced significant pressure, down 78% over the past year. According to InvestingPro analysis, the stock appears undervalued based on its Fair Value metrics.

The published study, known as PAX-D, was conducted by the University of Oxford and funded by the UK’s National Institute for Health and Care Research. Results showed that pramipexole, when added to existing antidepressant treatment, demonstrated significant symptom reduction compared to placebo at 12 weeks, though with high rates of adverse effects. While Alto maintains a strong liquidity position with a current ratio of 22.5, InvestingPro data indicates the company is rapidly burning through cash, a common challenge for clinical-stage biotechs.

ALTO-207, which Alto acquired based on the PAX-D findings, combines pramipexole with the antiemetic ondansetron in a fixed-dose formulation. The combination is designed to achieve rapid antidepressant effects while reducing the dose-limiting side effects typically associated with pramipexole alone.

"ALTO-207 is designed to consistently achieve rapid antidepressant effect through faster titration, while mitigating the dose-limiting nausea and vomiting experienced with pramipexole alone," said Amit Etkin, founder and CEO of Alto Neuroscience, according to the press release.

For the planned Phase 2b trial, Alto intends to collaborate with the National Health Service network, including PAX-D clinical sites.

In a previous Phase 2a trial conducted by Chase Therapeutics Corporation before Alto’s acquisition of the asset, the drug combination met primary and secondary endpoints, showing significantly greater improvements on depression scales compared to placebo. Patients in that study reached a mean dose of 4.1mg per day, with an adverse event rate similar to placebo during the maintenance period.

The clinical-stage biopharmaceutical company focuses on developing precision medicines for neuropsychiatric disorders using its Precision Psychiatry Platform, which measures brain biomarkers through various data points to identify patients more likely to respond to specific treatments.

This article is based on a press release statement from Alto Neuroscience. Analysts maintain a bullish outlook on ANRO, with price targets ranging from $4 to $17.34. Get deeper insights into Alto’s financial health metrics and 8 additional exclusive ProTips with InvestingPro.

In other recent news, Alto Neuroscience has announced the results of a Phase 2 trial for its ALTO-203 drug candidate, aimed at treating major depressive disorder. The trial data revealed mixed outcomes, with the drug showing potential benefits in attention and wakefulness, though it did not meet all depression-related endpoints. Analysts at H.C. Wainwright have maintained a Buy rating for Alto Neuroscience, reiterating a $10 price target, while William Blair also retained an Outperform rating despite the mixed trial results. Stifel continues to hold a Buy rating, highlighting the exploratory nature of the trial and the potential of ALTO-203 in other indications.

Additionally, Alto Neuroscience has acquired ALTO-207, a combination of pramipexole and ondansetron, to enhance its clinical pipeline, particularly for treatment-resistant depression. The acquisition is supported by prior positive results in Phase 2a trials and is expected to complement the company’s existing platform. Alto plans to initiate a Phase 2b trial for ALTO-207 in 2026, with topline data expected in 2027. The company aims to maintain its cash runway through 2028, as it continues to explore nondilutive partnering opportunities for ALTO-203.

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