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Alto Neuroscience stock price drops as trials fail to meet primary endpoints
Investing.com – Alto Neuroscience (NYSE ticker: ANRO) shares fell 8% on Wednesday after the company reported that its ALTO-101 Phase 2 proof-of-concept study for cognitive impairments related to schizophrenia did not achieve statistical significance on the primary endpoints.
ALTO-101 did not reach statistical significance versus placebo on the primary electroencephalogram (EEG) or cognitive endpoints. However, the study showed directional improvements on certain EEG measures, including a near-significant effect on theta-ITC (n=83, d=0.34, p=0.052), a metric associated with cognitive performance.
In a pre-specified subgroup analysis of patients with more severe cognitive impairment (n=59), ALTO-101 showed a nominally significant effect versus placebo on theta-ITC (d=0.44, p=0.03). The drug demonstrated good tolerability, with nausea and vomiting rates consistent with placebo. In both the active drug and placebo groups, a high proportion of patients experienced skin reactions at the injection site.
Based on these results, Alto does not plan to independently advance the development of ALTO-101 for cognitive impairments related to schizophrenia, and will prioritize allocating resources to ALTO-207, its lead program for treatment-resistant depression. The company has developed an improved, once-daily oral modified-release formulation of ALTO-101 and plans to seek collaboration opportunities for the formulation.
Alto’s ALTO-207 program remains on track to initiate its Phase 2b trial in the first half of 2026. The planned study will evaluate ALTO-207 as an adjunctive therapy in approximately 178 adult patients with treatment-resistant depression who have failed 2 to 5 prior treatments.
The company reported cash on hand of $275 million.
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