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Alto Neuroscience Inc, a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, announced the issuance of US Patent number 12,521,374 covering methods of treating depression with ALTO-207, a novel combination of pramipexole and ondansetron.
The patent protects a key aspect of ALTO-207 – the use of ondansetron to mitigate pramipexole-related side effects so that patients can achieve the higher dose levels needed to realize the antidepressant benefits of pramipexole. The newly issued patent claims further strengthen the company’s growing intellectual property estate supporting ALTO-207, a differentiated investigational therapy being developed for patients with treatment-resistant depression.
The company believes that, together with previously issued patents and pending applications in the United States and internationally, the ALTO-207 intellectual property portfolio provides protection extending into the mid-2040s, reinforcing the long-term commercial opportunity for the programme.
“This patent issuance meaningfully strengthens the foundation of our ALTO-207 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, and this milestone reflects both the novelty of ALTO-207 and our commitment to building long-term value for patients, clinicians, and shareholders. We believe the breadth and duration of our issued and pending claims position ALTO-207 as a potentially enduring asset in the treatment landscape for depression.”
Alto Neuroscience believes the issuance of this patent reinforces Alto’s strategy of building a portfolio of differentiated, innovative, precision-driven assets protected by robust intellectual property estates.
ALTO-207 is a fixed-dose combination of pramipexole, a dopamine D3-preferring D3/D2 agonist, approved for the treatment of Parkinson’s disease with demonstrated antidepressant effect, and ondansetron, an antiemetic, selective 5-HT3 receptor 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. ALTO-207 is being developed to address the significant unmet need for patients with treatment resistant depression.
In a randomized, placebo-controlled Phase 2a clinical trial evaluating ALTO-207 in 32 patients with depression ALTO-207 met primary and secondary endpoints demonstrating significantly greater improvements on MADRS compared to placebo. Patients randomized to receive ALTO-207 reached a mean dose of 4.1mg per day. ALTO-207 was well tolerated in the maintenance period of the study with an adverse event rate similar to placebo.
Alto Neuroscience with a mission redefines psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto’s Precision Psychiatry Platform 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. Alto’s clinical-stage pipeline includes novel drug candidates in bipolar depression, major depressive disorder, treatment resistant depression, and schizophrenia, and other mental health conditions.
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