Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ALTO-300 PO Tablet, ALTO-300 oral (PO) tablet
ALTO-300 · 3 trials · 1 indication
MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
The Montgomery-Åsberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. The change from baseline to the end of the study is the primary outcome.
The Clinical Global Impression scale - Severity (CGI-S) measures the severity of psychopathology in general where smaller scores indicate less illness and higher scores suggest more severe illness. Possible scores for this scale range from 1 to 7. The change from baseline to the end of the study is the primary outcome.
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Vital signs measured include blood pressure, heart rate, respiratory rate, temperature, and weight.
Blood samples for serum chemistry and hematology will be collected for clinical laboratory testing.
The Montgomery-Åsberg Depression Rating Scale (MADRS) measures the severity of depression where smaller scores indicate less depression and higher scores suggest more severe depression. Possible scores for this 10 item version range from 0 to 60. The change from baseline to the end of the study is the primary outcome.
The Clinical Global Impression scale - Severity (CGI-S) measures the severity of psychopathology in general where smaller scores indicate less illness and higher scores suggest more severe illness. Possible scores for this scale range from 1 to 7. The change from baseline to the end of the study is the primary outcome.
Incidence, severity, and relatedness of TEAEs,SAEs, discontinuation due to TEAEs, and deaths
| Arm | Type | Description |
|---|---|---|
| ALTO-300 | EXPERIMENTAL | Participants will receive ALTO-300 capsule once daily in the evening, from Day 1 to Day 42 in double blind (DB) treatment period. Eligible participants who will enter the open-label (OL) treatment period will receive ALTO-300 capsule once daily in the evening from OL baseline until the end of OL period/early termination visit (Up to 8 weeks). |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo capsule once daily in the evening, from Day 1 to Day 42 in double blind (DB) treatment period. |
| Name | Type | Description |
|---|---|---|
| ALTO-300 | DRUG | ALTO-300 capsule QD |
| Placebo | DRUG | Placebo capsule QD |
| ALTO-300 PO Tablet | DRUG | One tablet daily |
| ALTO-300 oral (PO) tablet | DRUG | One tablet daily |
Inclusion Criteria: * Have a diagnosis of moderate to severe major depressive disorder (MDD) * At Visit 1, currently taking a single SSRI, SNRI, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks by Visit 2 * Willing to comply with all study assessments and procedures ...
Top 20 of 31 competitors
ALTO-300 is an investigational oral small molecule being studied for the treatment of major depressive disorder (MDD). It is in Phase 2 clinical development and is not yet approved for any indication. All three of its clinical trials have enrolled adults aged 18 and older with MDD in the United States.
ALTO-300 targets MT1, MT2, and 5-HT2C receptors. It is a small molecule designed to act on these melatonin and serotonin receptor subtypes. This receptor profile distinguishes it from standard monoaminergic antidepressants and is the basis for its investigation in major depressive disorder.
ALTO-300 is being developed by Alto Neuroscience, Inc., which trades under the ticker ANRO. The company is advancing the asset in psychiatry, with major depressive disorder as its lead indication. ALTO-300 is an oral (PO) tablet formulation.
ALTO-300 is in Phase 2 clinical development. It has not been approved by the FDA and remains investigational. Three Phase 2 trials have been conducted or are ongoing, with two completed and one currently recruiting. Total enrollment across these studies is approximately 560 participants.
ALTO-300 has been evaluated in three Phase 2 trials in major depressive disorder. NCT05922878 is currently recruiting with 321 participants. NCT05157945 (ALTO-300-004) is completed with 148 participants, and NCT05118750 is completed with 91 participants. All were randomized, double-blind, and placebo-controlled studies conducted in the United States.
Yes. ALTO-300 PO Tablet and ALTO-300 oral (PO) tablet are alternative names for the same investigational drug. ALTO-300 is an orally administered small molecule developed by Alto Neuroscience for major depressive disorder. All names refer to the identical Phase 2 asset.