Alto Neuroscience plans to accelerate development of ALTO-207

Alto Neuroscience (ANRO) announced that, following a successful outcome from a recent FDA meeting, it plans to accelerate the development of ALTO-207 for people with treatment resistant depression. The $50M private placement announced supports expanded development of ALTO-207, and the company expects to initiate a Phase 3 study by early 2027 following Phase 3 readiness work and alignment with the FDA on the planned study design. Alto expects to initiate a Phase 2b, potentially pivotal, clinical trial of ALTO-207 in people with TRD by mid-2026. Alto now expects to initiate a Phase 3 clinical trial by early 2027 pending protocol alignment with the FDA and planned Phase 3 readiness work following the recent FDA discussion. Results from blinded PK analysis supports enhanced clinical trial execution efforts to mitigate non-compliance risk. A blinded PK analysis from the first cohort of patients in the ongoing Phase 2 study evaluating ALTO-100 as a treatment for bipolar depression and ALTO-101 for cognitive impairment associated with schizophrenia demonstrated that 96% of samples for ALTO-100 and 100% of samples tested for ALTO-101 qualified as PK positive. A sample was considered PK positive if observed drug levels were above a pre-specified minimum threshold. The result for ALTO-100 significantly exceeds typical compliance rates seen in similar CNS trials and underscores the effectiveness of the operational adjustments made to trial design and execution. The company believes this is a strong indicator of patient tolerability and engagement with the treatment regimen. Enrollment remains ongoing in the Phase 2, proof-of-concept study of ALTO-101 in CIAS, and the company expects to report topline data from this study in Q1 2026.