BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05201170 (PL9643 Vehicle Opthalmic Solution… in Dry Eye): BVCT ex-ante prediction vs. reported outcome

On 7 Mar 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 28 Feb 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05201170
Acronym
MELODY-1
Drug Name
PL9643 Vehicle Opthalmic Solution Opthalmic Solution
Drug MoA
MC1R/MC5R agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Eye Diseases
Indication
Dry Eye
Human Patients
240
Sponsor
Palatin Technologies
Phase
Phase 3

Prediction of , index 929

Prospective Prediction
Prediction Index
929
Prediction Date
Commercial Prediction
FAILURE
Technical Prediction
FAILURE

Readout of

Prediction Validation
Readout Date
Prediction To Readout
358 days in advance
Readout Data Interpretation
key primary and secondary endpoints not met.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 3, Multi-center, Randomized, Double-Masked and Vehicle-Controlled Study Evaluating the Efficacy and Safety of the Melanocortin, PL9643 Ophthalmic Solution, Compared to Vehicle in Subjects with Dry Eye
Phase
Phase 3
Status
Completed
Enrollment
575
Lead sponsor
Palatin Technologies, Inc
Conditions
Dry Eye; Dry Eye Syndromes
Interventions
DRUG: Vehicle Ophthalmic Solution; DRUG: PL9643 Ophthalmic Solution
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-12-30
Primary completion
2023-09-01
Completion
2023-11-21
Primary outcomes
  • Conjunctival Sum Lissamine Green Staining (Visit 6 (Day 85), Change from Pre-CAE to Post-CAE)
  • Ocular Pain (Change from Pre-CAE to Post-CAE at Visit 6 (Day 85))

NCT05201170 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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