What's Happening?
Alto Neuroscience, a biotech company based in Mountain View, California, has successfully raised $120 million in a private placement led by Commodore Capital. This funding will support the advancement of Alto's candidate for treatment-resistant depression
(TRD), ALTO-207, into pivotal trials. ALTO-207 is a fixed-dose combination of pramipexole, a dopamine D3/D2 agonist, and ondansetron, a 5-HT3 receptor antagonist. The company plans to initiate a phase 2b study in the first half of the year, followed by a phase 3 program in early 2027. Pramipexole, primarily used for Parkinson's disease, is also used off-label for TRD and treatment-resistant bipolar depression. Alto aims to mitigate pramipexole's side effects, such as nausea, by combining it with ondansetron. The company anticipates enrolling 178 patients in the US and UK for the phase 2b trial, comparing ALTO-207 to a placebo alongside baseline antidepressant medication.
Why It's Important?
The development of ALTO-207 is significant as it addresses the unmet medical need for effective treatments for depression that do not respond to standard antidepressants. Treatment-resistant depression affects millions globally, and current options are limited. Alto's approach, termed 'precision psychology,' aims to offer a more targeted treatment with fewer side effects. The success of ALTO-207 could provide a new therapeutic option for patients with TRD, potentially improving their quality of life. Additionally, the funding ensures Alto's operations are supported through 2028, allowing for continued research and development in this critical area of mental health.
What's Next?
Alto Neuroscience plans to move forward with the phase 2b trial of ALTO-207, with results expected to provide insights into its efficacy and safety. The company is also preparing for a phase 3 program, which could lead to marketing applications if successful. Alto is anticipating key data readouts from its precision psychiatry pipeline, including trials for cognitive impairments associated with schizophrenia and major depressive disorder. These developments could further establish Alto as a leader in innovative mental health treatments.
