ALTO-203 / Alto Neurosci - LARVOL DELTA

Next-Generation Pharmacotherapies for Unipolar Mood Disorders: A Leading Article on Phase II/III Drug Development Across Diverse Mechanisms. (PubMed, CNS Drugs) - "Following the US Food and Drug Administration (FDA) approval of esketamine and brexanolone in 2019, industry investment in therapeutics with novel mechanisms for mood and anxiety disorders has expanded, catalyzing a new wave of innovative interventions...The drug names discussed are ALTO-100, ALTO-203, ALTO-207, ALTO-300, BHV-7000, BI-1569912, BPL-003, COMP360, DT120, ELE-101, GATE-251, GH001, GM-1020, GM-2505, HLP003, MK-1942, NBI-1065845, NBI-1070770, NV-5138, PIPE-307, SEP-363856, SPT-300, VLS-01, and XEN1101. The US Clinical Trials registry (clinicaltrials.gov), MEDLINE, conference proceedings, and company communications such as press releases were consulted to obtain up-to-date trial information and reported outcomes. Overall, the therapeutic landscape shows an expanding range of clinical compounds under active development; nonetheless, persistent challenges remain, including approaches to therapeutics where functional unblinding may occur, the ways in which to..."

Journal • P2/3 data • Review • CNS Disorders • Mood Disorders • Psychiatry

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