BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05922878 (ALTO-300 in Major Depressive Disorder): BVCT ex-ante prediction vs. reported outcome

On 9 Nov 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 12 Feb 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically maybe significant (yet weak efficacy) and commercially maybe insufficient.

Clinical Trial

NCTID
NCT05922878
Drug Name
ALTO-300
Drug MoA
MT1/MIT2 agonist and 5HT2C antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Mental Disorders
Indication
Major Depressive Disorder
Human Patients
200
Sponsor
Alto Neuroscience
Phase
Phase 2

Prediction of , index 1841

Prospective Prediction
Prediction Index
1841
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in MADRS inferior to lumateperone)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak (additive) clinical benefit in MADRS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
95 days in advance
Readout Data Interpretation
ALTO-300 passed futility test yet failed to achieve sufficient efficacy at interim analysis; an increase of 50 biomarker positive patients are needed in the final analysis whose topline results are expected in mid-2026
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically maybe significant (yet weak efficacy) and commercially maybe insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Randomized, Double-Blind, Placebo-Controlled Study of ALTO-300 With an Open-Label Extension in Adults With Major Depressive Disorder
Phase
Phase 2
Status
Recruiting
Enrollment
321
Lead sponsor
Alto Neuroscience
Conditions
Major Depressive Disorder
Interventions
DRUG: ALTO-300; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-06-08
Primary completion
2026-12
Completion
2026-12
Primary outcomes
  • To assess efficacy of adjunctive ALTO-300 versus placebo on symptoms of MDD in a pre-defined subgroup of participants as measured by the change over time up to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS). (Change over time for up to week 6)

NCT05922878 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials