Alto Neuroscience Announces Phase 2b Trial Results for ALTO-100 in Major Depressive Disorder

Alto Neuroscience, Inc., a clinical-stage biopharmaceutical company dedicated to the creation of innovative precision medicines for neuropsychiatric conditions, has announced the results of their Phase 2b clinical trial for ALTO-100. This trial, which included patients with major depressive disorder (MDD), failed to meet its primary endpoint. The primary measure was the change in depressive symptoms from baseline using the Montgomery-Åsberg Depression Rating Scale (MADRS), with results showing no significant difference compared to a placebo.

Despite the disappointing outcome of this trial, ALTO-100 maintained a favorable safety and tolerability profile, aligning with findings from previous studies. Reported side effects such as headaches, nausea, and abnormal dreams occurred at rates comparable to those in the placebo group.

Dr. Amit Etkin, the founder and CEO of Alto Neuroscience, expressed disappointment over the trial results due to the significant unmet need in the MDD patient population. He commended his team for their pioneering work in using precision biomarkers in psychiatric studies. Dr. Etkin emphasized the company's commitment to their mission of advancing precision medicine in psychiatry. He also noted that Alto's robust financial reserves are expected to support the company's continued operations through several upcoming milestones in their clinical pipeline.

The Phase 2b study was a randomized, double-blind, placebo-controlled trial, which assessed the effectiveness of ALTO-100 in adults with MDD. This group was identified through an objective, memory-based cognitive biomarker before randomization. The trial was conducted at 34 sites across the United States and included 301 adult participants.

ALTO-100 did not show any significant improvement over placebo in reducing depressive symptoms based on the pre-specified key secondary analyses. Nevertheless, its safety profile remained consistent with previous trials, indicating no new safety concerns.

Dr. Adam Savitz, Chief Medical Officer of Alto Neuroscience, remarked on the trial's outcomes, acknowledging that the Phase 2b results did not replicate the positive findings from the Phase 2a trial. He highlighted the innovation in their approach of utilizing biomarkers to develop neuropsychiatric treatments and expressed gratitude to the patients, medical professionals, and support staff involved in the study.

In addition to its evaluation in MDD, ALTO-100 is also undergoing a Phase 2b study as an adjunctive treatment for bipolar depression. Alto Neuroscience remains optimistic about their current financial standing, which is projected to support their operations through 2027. Upcoming clinical readouts include two additional studies in MDD with ALTO-203 and ALTO-300, expected in the first half of 2025.

Alto Neuroscience is dedicated to transforming psychiatry by leveraging neurobiology to develop personalized and effective treatments for mental health conditions. Their Precision Psychiatry Platform™ utilizes brain biomarkers, such as EEG activity and neurocognitive assessments, to identify patients who are most likely to benefit from their drug candidates. The company’s pipeline includes treatments for depression, PTSD, schizophrenia, and other psychiatric disorders.