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LTI-03

Phase 2

Idiopathic Pulmonary Fibrosis (IPF) | Small molecule | Respiratory |Rein Therapeutics, Inc.|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06968845A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary FibrosisPHASE2 RECRUITING 120Feb 2, 2026Dec 31, 2027Jun 5, 202616 United States, Australia +2
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Study Endpoints
Primary Endpoints
Safety and Tolerability as measured by the incidence of treatment-emergent adverse events (TEAEs)
Day 1 through Week 24
Secondary Endpoints
Change from baseline in forced vital capacity (FVC)
Day 1 through Week 24
Change from baseline in percent predicted FVC
Day 1 through Week 24
Change from baseline in lung fibrosis measured by high resolution computed tomography (HRCT)
Day 1 through Week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
(1) 2.5 mg LTI-03 capsule BIDEXPERIMENTALCaveolin-1-Scaffolding-Protein-Derived Peptide
(2) 2.5 mg LTI-03 capsules BIDEXPERIMENTALCaveolin-1-Scaffolding-Protein-Derived Peptide
(1) Placebo capsule BIDPLACEBO_COMPARATORLactose powder
(2) Placebo capsules BIDPLACEBO_COMPARATORLactose powder
Interventions
NameTypeDescription
LTI-03DRUGCaveolin-1-Scaffolding-Protein-Derived Peptide
Dry Powder InhalerDEVICEPlastiape Monodose RS01 Model 7
PlaceboDRUGLactose powder
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: 1. Male or female age 40 years or older. 2. Willing and able to provide written informed consent. 3. Diagnosis of IPF within 5 years of Screening as confirmed by a centrally read HRCT of the chest as defined by the ATS/ERS/JRS/ALAT guideline. HRCT lung fibrosis by central read d...

Countries:United StatesAustraliaPolandUnited Kingdom
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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT06968845lastUpdatePostDate: changed
LOWJun 5, 2026NCT06968845lastUpdatePostDate: changed
LOWJun 5, 2026NCT06968845lastUpdatePostDate: changed
LOWJun 5, 2026NCT06968845lastUpdatePostDate: changed
LOWJun 3, 2026NCT06968845lastUpdatePostDate: changed
LOWJun 3, 2026NCT06968845lastUpdatePostDate: changed
LOWMay 26, 2026NCT06968845primaryCompletionDate: changed
LOWMay 24, 2026NCT06968845studyFirstPostDate: changed