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GB0139

Phase 2

Idiopathic Pulmonary Fibrosis (IPF) | Small molecule | Respiratory |Galecto, Inc.|Last Updated: May 22, 2024

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 Enrollment172
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03832946A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)PHASE2 COMPLETED 172Feb 19, 2019May 17, 2023May 22, 2024128 United States, Australia +13
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Study Endpoints
Primary Endpoints
Annual Rate of Decline in Forced Vital Capacity (FVC)
52 weeks

Efficacy of GB0139 as measured by the annual rate of decline in FVC expressed in mL

Secondary Endpoints
Number of Participants With Respiratory Related Hospitalizations
52 weeks
Assessment of Respiratory Related Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)
52 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
A. GB0139 3 mg once a dayEXPERIMENTALInhalation of GB0139
B. Placebo once a dayPLACEBO_COMPARATORInhalation of Placebo
Interventions
NameTypeDescription
GB0139DRUGGB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.
PlaceboDRUGPlacebo is administered as inhalation once a day
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites128

Inclusion Criteria: 1. Male and female subjects aged ≥ 40 years of age with a diagnosis of IPF established during the previous five years according to ATS/ERS/Fleischner criteria. 2. Lung function parameters as follows: 1. Forced Vital Capacity (FVC) \> 45% of the predicted value at screening ...

Countries:United StatesAustraliaBelgiumCanadaFranceGeorgiaGermanyIrelandIsraelItalyPolandRussiaSpainUkraineUnited Kingdom
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