Alto Neuroscience, Inc. (ANRO) received U.S. Patent No. 12,521,374 on January 14, 2026 for its fixed‑dose combination of pramipexole and ondansetron, the ALTO‑207 therapy designed to treat patients with treatment‑resistant depression.
The patent protects the use of ondansetron to counteract the side‑effect profile of pramipexole, allowing the company to increase dosing and improve tolerability. By securing this intellectual‑property moat, Alto extends the exclusivity window for ALTO‑207 into the mid‑2040s, a critical advantage for a clinical‑stage biotech that relies on a durable patent life to attract investment and future partnerships.
ALTO‑207 has already demonstrated positive outcomes in a Phase 2a study, meeting primary and secondary endpoints on the MADRS scale and achieving a mean dose of 4.1 mg per day with good tolerability. The company plans to launch a Phase 2b trial in the second half of 2026 and a Phase 3 study in early 2027, positioning the therapy for a potential regulatory submission in the next few years.
Alto’s recent financing has bolstered its cash runway, with a $138.3 million balance reported in Q3 2025 and an additional $50 million private placement in October 2025 that raised the total to approximately $184 million. The infusion is expected to fund operations through 2028, giving the company the financial flexibility to advance ALTO‑207 and other pipeline candidates such as ALTO‑100 and ALTO‑101.
CEO Amit Etkin said, 'This patent issuance meaningfully strengthens the foundation of our ALTO‑207 franchise. 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.'
The announcement was met with a positive market reaction, as investors and industry observers noted the strategic importance of the new patent for the company’s long‑term commercial prospects and the confidence it signals in Alto’s precision‑psychiatry platform.
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