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NCT05954988 (LTI-03 in Idiopathic Pulmonary Fibrosis): BVCT ex-ante prediction vs. reported outcome

On 12 May 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 13 Nov 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (safety) and commercially TBD.

Clinical Trial

NCTID
NCT05954988
Drug Name
LTI-03
Drug MoA
CAV1-like peptide
Drug Modality
peptide
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Idiopathic Pulmonary Fibrosis (IPF)
Human Patients
24
Sponsor
Aileron Therapeutics
Phase
Phase 1

Prediction of , index 1604

Prospective Prediction
Prediction Index
1604
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit with superior-to-bexotegrast efficacy in FVC)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
185 days in advance
Readout Data Interpretation
LTI03 is safe and achieved statistically significant in four of eight IPF biomarkers for cohort 1 and cohort 2
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (safety) and commercially TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Safety, Tolerability and Pharmacodynamic Biomarker Study of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Recently Diagnosed, Treatment Naïve Subjects With IPF
Phase
Phase 1
Status
Completed
Enrollment
24
Lead sponsor
Rein Therapeutics
Conditions
Idiopathic Pulmonary Fibrosis
Interventions
DRUG: LTI-03; DRUG: Placebo
Design
Randomized · Sequential · Quadruple
Primary purpose
Other
Start
2023-07-06
Primary completion
2024-09-25
Completion
2024-09-25
Results first posted
2025-07-31
Primary outcomes
  • Incidence of Treatment-emergent Adverse Events (TEAEs) (21 days (dosing x 14 days; follow up x 7 days))

NCT05954988 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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