On Tuesday, Alto Neuroscience, Inc. (NYSE:ANRO) revealed that the Phase 2b study of ALTO-100 for major depressive disorder (MDD) did not meet its primary endpoint compared to placebo.
The biomarker-defined major depressive disorder patient group treated with ALTO-100 did not demonstrate a statistically significant improvement in depressive symptoms compared to placebo.
ALTO-100 did not demonstrate a benefit over the placebo on the pre-specified key secondary analyses.
Also Read: Treatment Patch For Schizophrenia: Newly Listed Alto Neuroscience Is Uniquely Positioned In Neuropsychiatry Landscape.
ALTO-100 continued to demonstrate a favorable safety and tolerability profile, with no new safety signals observed in this study compared to the previously completed clinical trials of ALTO-100.
- The most common adverse events from the trial related to treatment with ALTO-100 were headache, nausea, and abnormal dreams – all of which were experienced at similar rates to placebo.
The company expects to complete an analysis of the full data set to determine the most appropriate next steps, if any, to further evaluate ALTO-100 in major depressive disorder.
ALTO-100 is also being evaluated as an adjunctive treatment in a Phase 2b study for bipolar depression.
The company expects its current cash position of $194 million to fund planned operations into 2027 and through multiple upcoming clinical readouts, including two additional readouts in major depressive disorder, with ALTO-203 and ALTO-300 expected in the first half of 2025.
William Blair notes that despite the setback with ALTO-100, which may raise concerns among investors about Alto's Precision Psychiatry Platform, the analysts do not consider this single failure to undermine the validity of their biomarker enrichment strategy.
The analyst is now focused on the upcoming ALTO-300 Phase 2b results in major depressive disorder (MDD), anticipated in the first half of 2025, for further insights.
"While data points draw increased scrutiny on the biomarker stratification approach, historically placebo-controlled MDD studies have been high-risk, and this one appears no different. Still, in our discussions with management, it remained confident in the stratification approach, and we will await a fuller dataset to better understand this optimism despite the negative Phase 2b readout." William Blair analysts write.
The analyst maintains the Outperform rating.
Price Action: At last check on Wednesday, ANRO stock was down 67.70% to $4.70.
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