Alto Neuroscience acquires novel TRD treatment candidate

Published 03/06/2025, 11:18
Alto Neuroscience acquires novel TRD treatment candidate

MOUNTAIN VIEW, Calif. - Alto Neuroscience, Inc. (NYSE: ANRO), a clinical-stage biopharmaceutical company with a market capitalization of approximately $70 million, has announced the acquisition of a portfolio of dopamine agonist drug combinations from Chase Therapeutics Corporation. According to InvestingPro data, the company’s stock has experienced significant volatility, currently trading near $2.60, down over 76% from its 52-week high. This includes ALTO-207, previously known as CTC-501, a drug candidate aimed at treating treatment-resistant depression (TRD).

ALTO-207 is a fixed-dose combination of pramipexole and ondansetron, intended to offer rapid antidepressant effects and mitigate adverse events associated with pramipexole alone. The drug has completed a Phase 2a study, meeting primary and secondary endpoints and showing significant improvement in depression symptoms compared to placebo.

Alto plans to initiate a Phase 2b trial by mid-2026, with the potential for it to be a pivotal study, and expects to report topline data in 2027. The company’s current cash is anticipated to fund operations into 2028, including at least five planned clinical study readouts. InvestingPro analysis reveals that while Alto holds more cash than debt on its balance sheet, it’s currently burning through cash rapidly - a crucial factor for investors to monitor. For detailed financial health metrics and 8 additional key ProTips, consider exploring InvestingPro’s comprehensive analysis.

Amit Etkin, M.D., Ph.D., CEO of Alto Neuroscience, emphasized the drug’s potential to address the unmet needs of patients with TRD, citing the proprietary insights on dopamine biomarkers in depression that Alto has developed. The transaction with Chase Therapeutics is seen as strategic, adding a significant late-stage clinical readout to Alto’s pipeline without affecting its current cash guidance.

The completed Phase 2a trial for CTC-501 revealed that patients could tolerate a mean dose of 4.1mg per day, with 67% reaching the highest allowable dose of 5mg/day. The drug was generally well tolerated and showed statistically significant improvements in depression symptoms.

Alto also acquired CTC-413, now ALTO-208, a drug in development for Parkinson’s disease. The terms of the asset purchase agreement include an upfront payment of $1.75 million to Chase Therapeutics, with potential future milestone payments totaling up to $71.5 million.

The company will host a conference call and webcast today at 8 a.m. ET to discuss the acquisition, featuring experts in psychiatry and computational psychiatry. The acquisition is based on a press release statement by Alto Neuroscience.

In other recent news, Alto Neuroscience has reported progress in its drug trials for ALTO-300, a treatment for major depressive disorder (MDD). The company shared findings from its Phase 2a and ongoing Phase 2b trials at the American Society of Clinical Psychopharmacology Annual Meeting. The 25mg dose of ALTO-300, also known as agomelatine, demonstrated a favorable tolerability profile without significant liver function test (LFT) elevations, a concern associated with the higher 50mg dose. The Phase 2a trial, involving 239 patients, showed no significant LFT elevations, and the ongoing Phase 2b trial has not required any patient cessation due to liver enzyme elevation. ALTO-300 is linked to an EEG biomarker, suggesting a mechanistic connection between the drug and patient selection. The most common adverse event reported was a headache, and the Phase 2b trial includes a stopping rule for elevated liver enzymes, which has not been triggered. The company continues to focus on developing precision medicines for neuropsychiatric disorders, with a pipeline that includes treatments for bipolar depression and schizophrenia.

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