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NCT05321420 (LYT100 in Idiopathic Pulmonary Fibrosis): BVCT ex-ante prediction vs. reported outcome

On 6 Aug 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 16 Dec 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant yet weak (in FVCpp) and commercially insufficient (inferior to pirfenidone);.

Clinical Trial

Acronym
ELEVATE
Drug Name
LYT100
Drug MoA
a deuterated form of pirfenidone
Drug Modality
deuterated formulation
Drug Class
Best-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Idiopathic Pulmonary Fibrosis
Human Patients
240
Sponsor
PureTech
Phase
Phase 2

Prediction of , index 1719

Prospective Prediction
Prediction Index
1719
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in FVC inferior to pirfenidone)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in FVC against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
132 days in advance
Readout Data Interpretation
LYT100 550mg TID (equivalent to the approved pirfenidone 801 mg TID) achieved a 1.62% placebo-adjusted improvement in FVCpp; at least numerically inferior to the SoC (pirfenidone 801mg TID) that achieved a 1.97% placebo-adjusted improvement in FVCpp
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant yet weak (in FVCpp) and commercially insufficient (inferior to pirfenidone);
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Phase
Phase 2
Status
Active not recruiting
Enrollment
240
Lead sponsor
PureTech
Conditions
Idiopathic Pulmonary Fibrosis
Interventions
DRUG: Placebo; DRUG: Pirfenidone; DRUG: Deupirfenidone
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-07-22
Primary completion
2024-10-15
Completion
2025-12-31
Primary outcomes
  • Rate of decline in Forced Vital Capacity over 26 weeks (Part A) (26 weeks)

NCT05321420 on ClinicalTrials.gov

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