Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALTO-203 25 μg · 1 trial · 2 indications
The Bond-Lader Visual Analogue Scale (BL-VAS) is used to measure the effects of drugs on the participants' mood. It consists of 16 VAS measurements of different mood state. For each question, the participants will rate their feelings at the time of assessment by indicating the point on the 10 cm line which best represents their mood. Each item is scored by measuring the position relative to the left-hand end of the line. The combined domains of alertness and mood will be assessed for the primary endpoint.
Incidence, severity, and relatedness of TEAEs, SAEs, discontinuation due to TEAEs.
| Arm | Type | Description |
|---|---|---|
| ALTO-203 25 μg | EXPERIMENTAL | Drug: ALTO-203 25 μg Single-Dose Treatment Period: Single Dose, ALTO-203 25 μg Multi-Dose Treatment Period: ALTO-203 25 μg, administered orally, once daily for 28 days |
| ALTO-203 75 μg | EXPERIMENTAL | Drug: ALTO-203 75 μg Single-Dose Treatment Period: Single Dose, ALTO-203 75 μg Multi-Dose Treatment Period: ALTO-203 75 μg, administered orally, once daily for 28 days |
| Placebo | PLACEBO_COMPARATOR | Drug: Placebo Single-Dose Treatment Period: Single Dose, Placebo Multi-Dose Treatment Period: Placebo, administered orally, once daily for 28 days |
| Name | Type | Description |
|---|---|---|
| ALTO-203 25 μg | DRUG | Active, ALTO-203 25 μg |
| ALTO-203 75 μg | DRUG | Active, ALTO-203 75 μg |
| Placebo | DRUG | Comparator, Placebo-to-match |
Inclusion Criteria: * Have a diagnosis of moderate major depressive disorder (MDD) * Presence of anhedonia symptoms * Not taking antidepressant at Screening Visit 2 * Willing to comply with all study assessments and procedures Exclusion Criteria: * Evidence of unstable medical condition * Diagnos...
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ALTO-203 25 μg is an investigational small molecule being developed for the treatment of Major Depressive Disorder (MDD). It is currently in Phase 2 clinical development and has been studied in patients with MDD, including those with anhedonia, a symptom of depression characterized by reduced ability to experience pleasure.
ALTO-203 25 μg is being developed by Alto Neuroscience, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol ANRO. The company is focused on developing precision treatments for psychiatric conditions, including Major Depressive Disorder.
ALTO-203 25 μg is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug remains under clinical investigation for Major Depressive Disorder.
ALTO-203 25 μg has been studied in one completed Phase 2 clinical trial registered as NCT06391563, titled 'PD, PK, and Safety of ALTO-203 in Patients With MDD.' This randomized, double-blind, placebo-controlled trial enrolled 69 participants with Major Depressive Disorder and anhedonia in the United States.
ALTO-203 25 μg is a specific dose strength of the investigational drug ALTO-203. The 25 μg formulation is being studied for its pharmacokinetics, pharmacodynamics, and safety in patients with Major Depressive Disorder, as part of the broader ALTO-203 development program.