Alto Neuroscience Secures Key Patent for ALTO-207 Depression Treatment, Extending IP Protection to Mid-2040s
Key Insights
Alto Neuroscience received US Patent 12,521,374 for ALTO-207 (search), a novel combination therapy of pramipexole and ondansetron for treatment-resistant depression (search).
The patent specifically protects the use of ondansetron to mitigate pramipexole side effects, enabling higher therapeutic doses needed for antidepressant benefits.
ALTO-207 (search) demonstrated significant improvements on MADRS scores compared to placebo in a Phase 2a trial with 32 depression (search) patients.
Alto Neuroscience Inc announced the issuance of US Patent number 12,521,374, covering methods of treating depression (search) with ALTO-207 (search), a novel fixed-dose combination of pramipexole and ondansetron. The patent strengthens the clinical-stage biopharmaceutical company's intellectual property portfolio for its investigational therapy targeting treatment-resistant depression (search).
Patent Protects Key Therapeutic Innovation
The newly issued patent protects a critical aspect of ALTO-207 (search)'s mechanism: the use of ondansetron to mitigate pramipexole-related side effects, allowing patients to achieve higher dose levels necessary to realize the antidepressant benefits of pramipexole. This approach addresses a significant limitation in using pramipexole for depression (search) treatment, where dose-limiting adverse events typically prevent patients from reaching therapeutic levels.
"This patent issuance meaningfully strengthens the foundation of our ALTO-207 (search) franchise," said Amit Etkin, founder and chief executive officer of Alto Neuroscience. "Robust and durable intellectual property is critical as we advance precision-based treatments for depression (search), and this milestone reflects both the novelty of ALTO-207 and our commitment to building long-term value for patients, clinicians, and shareholders."
Extended IP Protection Through Mid-2040s
Alto Neuroscience believes that together with previously issued patents and pending applications in the United States and internationally, the ALTO-207 (search) intellectual property portfolio provides protection extending into the mid-2040s. This extended timeline reinforces the long-term commercial opportunity for the program and positions ALTO-207 as a potentially enduring asset in the depression (search) treatment landscape.
ALTO-207 Mechanism and Clinical Development
ALTO-207 (search) combines pramipexole, a dopamine D3 (search)-preferring D3/D2 agonist approved for Parkinson's disease (search) with demonstrated antidepressant effects, and ondansetron, an antiemetic selective 5-HT3 receptor (search) antagonist. As a fixed-dose combination, ALTO-207 is designed to enable rapid titration and higher dosing by mitigating the dose-limiting adverse events typically experienced with pramipexole monotherapy.
The therapy is being developed to address the significant unmet need for patients with treatment-resistant depression (search), a condition where standard antidepressant treatments have failed to provide adequate therapeutic benefit.
Phase 2a Trial Results Demonstrate Efficacy
In a randomized, placebo-controlled Phase 2a clinical trial evaluating ALTO-207 (search) in 32 patients with depression (search), the combination therapy met both primary and secondary endpoints, demonstrating significantly greater improvements on the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to placebo. Patients randomized to receive ALTO-207 reached a mean dose of 4.1mg per day, indicating successful dose escalation enabled by the ondansetron component.
ALTO-207 (search) was well tolerated during the maintenance period of the study, with an adverse event rate similar to placebo, supporting the combination's safety profile and the protective effect of ondansetron against pramipexole-related side effects.
Precision Psychiatry Platform Integration
Alto Neuroscience's approach extends beyond traditional drug development through its Precision Psychiatry Platform, which measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. This precision medicine approach aims to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options.
The company's clinical-stage pipeline includes novel drug candidates targeting bipolar depression (search), major depressive disorder (search), treatment-resistant depression (search), schizophrenia (search), and other mental health conditions, all supported by this biomarker-driven patient selection strategy.