agomelatine (ALTO-300) / Alto Neurosci - LARVOL DELTA

Alto Neuroscience Announces U.S. Patent Granted Covering ALTO-300 as a Treatment for Patients with Major Depressive Disorder Characterized by an Electroencephalogram Biomarker (Businesswire) - "Alto Neuroscience...announced that the U.S. Patent and Trademark Office has granted U.S. Patent Number 12,226,375, with method claims pertaining to treatment of major depressive disorder (MDD) in patients with inadequate response to an antidepressant. The method includes treatment with ALTO-300 as an adjunctive therapy and patient selection using specific electroencephalogram (EEG) measures. As granted, not accounting for any potential patent term extensions, the patent is expected to cover the use of ALTO-300 in the EEG-defined patient population until 2044."

Patent • Major Depressive Disorder

Alto Neuroscience Announces Favorable Outcome from Interim Analysis of ALTO-300 Phase 2b Major Depressive Disorder Trial (Businesswire) - "Alto Neuroscience, Inc...today announced a favorable outcome from the planned interim analysis for the Phase 2b trial of ALTO-300 as an adjunctive treatment for patients with major depressive disorder (MDD). Based on the results of the interim analysis, the Phase 2b trial will continue with an increase of approximately 50 biomarker positive patients in the final analysis sample. Topline results are expected in mid-2026....The company expects to enroll approximately 200 biomarker positive patients in the final analysis sample."

P2b data • Trial status • Major Depressive Disorder

Study of ALTO-300 in MDD (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Alto Neuroscience | Trial completion date: Oct 2024 ➔ May 2025 | Trial primary completion date: Jul 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Biomarker-Based Enrichment Strategy for Neuropsychiatric Drug Development: Examples from Two Ongoing Phase 2b Studies (ASCP 2024) - P2 | "Here, we present our enrichment strategy in two ongoing Phase 2b studies in MDD (ALTO-100-201, NCT05712187; ALTO-300-201, NCT05922878) investigating candidate antidepressants with distinct and novel mechanisms of action. 2. Recognize the importance of an effective, feasible, and scalable biomarker enrichment strategy for precision psychiatry drug development."

Biomarker • P2b data • CNS Disorders • Depression • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry

Development and Prospective Replication of Biomarkers for Predicting Treatment Outcome With ALTO-100 and ALTO-300 in Major Depression: Data From Multiple Phase 2 Programs (SOBP 2024) - "Replicated treatment-predictive biomarkers were identified for both ALTO-100 and ALTO-300, with both drugs now in large placebo-controlled phase 2b trials stratified by their biomarkers. Successful outcomes from these trials have the potential to transform precision drug development in psychiatry."

Biomarker • Clinical • P2 data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Identification and Prospective Replication of an EEG Biomarker for Predicting the Antidepressant Effect of ALTO-300 in Patients With Major Depression: Results From a Large Phase 2a Study (SOBP 2024) - P2 | "These findings provide strong evidence that ALTO-300 is more effective at treating symptoms of depression among MDD patients with a machine learning-identified rsEEG biomarker than those without the biomarker. Based on these findings, a prospective, biomarker-stratified, placebo-controlled phase 2b efficacy study is underway (NCT05922878)."

Biomarker • Clinical • P2a data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Identification and Prospective Replication of an EEG Biomarker for Predicting the Antidepressant Effect of ALTO-300 in Patients With Major Depression: Results from a Large Phase 2a Study (ACNP 2023) - P2 | "These findings provide strong evidence that ALTO-300 is significantly more effective at treating symptoms of depression among MDD patients with a machine learning-identified rsEEG biomarker than those who do not have the biomarker. Based on these findings, a prospective, biomarker-stratified, placebo-controlled phase 2b efficacy study is underway (NCT05922878)."

Biomarker • Clinical • P2a data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Study of ALTO-300 in MDD (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Alto Neuroscience

New P2 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

ALTO-300 in Depression (ALTO-300-004) (clinicaltrials.gov) - P2 | N=148 | Completed | Sponsor: Alto Neuroscience | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

ALTO-300 in Depression (clinicaltrials.gov) - P2 | N=91 | Completed | Sponsor: Alto Neuroscience | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

ALTO-300 in Depression (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: Alto Neuroscience | Recruiting ➔ Active, not recruiting | N=200 ➔ 100

Enrollment change • Enrollment closed • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

ALTO-300 in Depression (ALTO-300-004) (clinicaltrials.gov) - P2 | N=148 | Active, not recruiting | Sponsor: Alto Neuroscience | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

ALTO-300 in Depression (ALTO-300-004) (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Alto Neuroscience | Trial primary completion date: Dec 2022 ➔ Mar 2023

Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

ALTO-300 in Depression (ALTO-300-004) (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Alto Neuroscience | Trial completion date: Sep 2022 ➔ Feb 2023 | Trial primary completion date: Jul 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

ALTO-300 in Depression (ALTO-300-004) (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: Alto Neuroscience; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

ALTO-300 in Depression (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: Alto Neuroscience; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry