Phase 2 ALTO-203 Study for Major Depressive Disorder Begins

A clinical-stage biopharmaceutical firm has embarked on a Phase 2 study to explore the efficacy of a novel treatment for major depressive disorder (MDD). The drug in question, ALTO-203, has shown promising results in Phase 1 trials, where it exhibited an increase in positive emotions and favorable tolerability.

The study, which is double-blind and involves both single and multiple doses, will assess the pharmacodynamic effects and safety profile of ALTO-203 in MDD patients. The drug has been identified as a potential antidepressant, particularly for those with high levels of anhedonia—a symptom characterized by a lack of interest or pleasure in activities.

Jessica Powell, the chief development officer of the company, highlighted this as the fifth Phase 2 study in their pipeline, indicating significant progress in their mission to advance mental healthcare. ALTO-203 has been shown to have an acute effect on positive emotions in a Phase 1 study, which the company believes could be a key attribute for an antidepressant.

The drug is a small molecule histamine H3 receptor inverse agonist, which is being developed specifically for MDD patients with elevated anhedonia. The Phase 2 study will include two treatment periods: a single-dose phase to evaluate pharmacodynamic responses and a 28-day multi-dose phase to assess safety.

The first phase will use a randomized design to compare the effects of ALTO-203 to a placebo, with the primary outcome being an acute change in positive emotion. The second phase will explore changes in depression, anhedonia, and other symptoms, alongside cognitive function and physiological measures.

The company plans to enroll approximately 60 adult participants with MDD who exhibit anhedonia and expects to report the study's topline data in the first half of 2025. Further details about the trial can be found on ClinicalTrials.gov.

Alto Neuroscience is dedicated to revolutionizing psychiatry through the development of personalized and highly effective treatments based on neurobiology. Their Precision Psychiatry Platform™ utilizes brain biomarkers, including EEG activity and neurocognitive assessments, to identify patients likely to respond to their treatments. The company's pipeline includes drug candidates for a range of mental health conditions, including PTSD and schizophrenia.

The study's initiation represents a significant step forward in the development of ALTO-203 and the broader goal of enhancing mental health treatment options. With a focus on precision medicine, Alto Neuroscience aims to provide tailored solutions for individuals suffering from mental health disorders.