ALTO-100 / Alto Neurosci - LARVOL DELTA

ALTO-100 in Bipolar Disorder with Depression (BD-D) (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Alto Neuroscience

New P2 trial • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

ALTO-100-201: Phase 2b Study of ALTO-100 in MDD (clinicaltrials.gov) - P2 | N=301 | Active, not recruiting | Sponsor: Alto Neuroscience | Recruiting ➔ Active, not recruiting

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

Alto Neuroscience Announces Enrollment Completion in Phase 2b Study of ALTO-100 in Major Depressive Disorder (Businesswire) - "Alto Neuroscience, Inc...announced the completion of enrollment in its Phase 2b study of ALTO-100 in adults with major depressive disorder (MDD). Topline results from this study are expected to be reported in October 2024."

Enrollment closed • P2b data • Major Depressive Disorder

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 a Cognitive Biomarker for Predicting the Antidepressant Effect of ALTO-100, a Novel Pro-Plasticity Drug Candidate, in Patients With Major Depression: Results From a Large Phase 2a Study (SOBP 2024) - P2 | "Our findings suggest that ALTO-100 is more effective at treating depression in MDD with a poor cognition biomarker than in those without the biomarker. Based on these results, a prospective, biomarker-stratified, placebo-controlled phase 2b efficacy study is underway (NCT05712187)."

Biomarker • Clinical • P2a data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Phase 2b Study of ALTO-100 in MDD (clinicaltrials.gov) - P2 | N=266 | Recruiting | Sponsor: Alto Neuroscience | Phase classification: P2b ➔ P2

Phase classification • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Identification and Prospective Replication of a Cognitive Biomarker for Predicting the Antidepressant Effect of ALTO-100, a Novel Pro-Plasticity Drug, in Patients With Major Depression: Results From a Large Phase 2a Study (ACNP 2023) - P2, P2b | "These data provide compelling evidence that ALTO-100, a first-in-class compound that increases neuroplasticity, is considerably more effective at treating symptoms of depression among MDD patients with a poor cognition biomarker profile than those without. This result stands in contrast to standard-of-care antidepressants, which are less effective in patients with the poor cognition biomarker profile. Based on these results, a prospective, biomarker-stratified, placebo-controlled phase 2b efficacy study is underway (NCT05712187)."

Biomarker • Clinical • P2a data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Major Depressive Disorder • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry • Suicidal Ideation

Alto-100 improves pattern separation in mice through a neurogenesis-dependent mechanism (Neuroscience 2023) - "We demonstrated that chronic pharmacological treatment with the compound ALTO-100 reliably improves context discrimination in non-irradiated mice, as we have previously shown.Furthermore, this effect appears to be neurogenesis-dependent, as X-irradiation and ablation of neurogenesis was able to block the effects of ALTO-100 on pattern separation."

Preclinical • CNS Disorders • BDNF

Phase 2b Study of ALTO-100 in MDD (clinicaltrials.gov) - P2b | N=266 | Recruiting | Sponsor: Alto Neuroscience | N=200 ➔ 266 | Trial completion date: Mar 2024 ➔ Sep 2024 | Trial primary completion date: Jan 2024 ➔ Aug 2024

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

A Pro-Neurogenic Compound, Alto-100, Improves Pattern Separation in Mice (SOBP 2023) - "Histological measures of neurogenesis in these subjects will also be presented. Conclusions We observed that chronic treatment with Alto-100, a neurogenic compound, improved performance on a contextual fear discrimination task without having a notable effect on baseline contextual fear conditioning."

Preclinical • CNS Disorders • Depression • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry

Pilot Decentralized Trial (clinicaltrials.gov) - P2 | N=21 | Completed | Sponsor: Alto Neuroscience | Active, not recruiting ➔ Completed | N=50 ➔ 21 | Trial completion date: May 2023 ➔ Jan 2023

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

Phase 2b Study of ALTO-100 in MDD (clinicaltrials.gov) - P2b | N=200 | Recruiting | Sponsor: Alto Neuroscience

New P2b trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

ALTO-100 in MDD and/or PTSD (clinicaltrials.gov) - P2 | N=245 | Completed | Sponsor: Alto Neuroscience | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry

Pilot Decentralized Trial (clinicaltrials.gov) - P2 | N=50 | Active, not recruiting | Sponsor: Alto Neuroscience | Recruiting ➔ Active, not recruiting | N=225 ➔ 50

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

ALTO-100 in MDD and/or PTSD (clinicaltrials.gov) - P2 | N=245 | Active, not recruiting | Sponsor: Alto Neuroscience | Recruiting ➔ Active, not recruiting | N=350 ➔ 245 | Trial completion date: Jul 2023 ➔ Feb 2023 | Trial primary completion date: May 2023 ➔ Dec 2022

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry

ALTO-100 in Major Depressive Disorder (clinicaltrials.gov) - P2 | N=225 | Recruiting | Sponsor: Alto Neuroscience

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