ALTO-203 / Alto Neurosci - LARVOL DELTA

ALTO-203-201: PD, PK, and Safety of ALTO-203 in Patients With MDD (clinicaltrials.gov) - P2 | N=69 | Completed | Sponsor: Alto Neuroscience | Recruiting ➔ Completed

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

Effects of a novel histamine 3 receptor (H3R) on positive emotion and reward processing: methods and preliminary data in an ongoing phase 2 proof-of-concept study (ECNP 2024) - "In a phase 1 trial, ALTO-203 acutely increased positive subjective emotion measured by the Bond-Lader Visual Analogue Scale (BL-VAS) at a level comparable to modafinil, a drug known to enhance reward system dopamine release. Results from preclinical and early human studies show promising pharmacodynamic effects of ALTO-203 on reward system dopaminergic functioning and analogous subjective responses in humans. Based on these promising translational findings, ALTO-203 is presently in a Phase 2 POC study to determine its clinical and biological effects in patients with MDD and anhedonia."

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

PD, PK, and Safety of ALTO-203 in Patients With MDD (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Alto Neuroscience

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

Alto Neuroscience Announces Initiation of Phase 2 Study of ALTO-203 in Patients with Major Depressive Disorder (Businesswire) - "Alto Neuroscience, Inc...announced the initiation of its Phase 2 double-blind, single- and multiple-dose study to determine the pharmacodynamic effects of ALTO-203 in MDD patients as well as assess its safety, tolerability, and pharmacokinetics....Alto expects to enroll approximately 60 adult participants with MDD and evidence of anhedonia, and report topline data from this study in the first half of 2025."

New P2 trial • CNS Disorders • Major Depressive Disorder