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EP-104GI

Phase 1

Eosinophilic Esophagitis | Small molecule | Other |Eupraxia Pharmaceuticals Inc.|Last Updated: Mar 19, 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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment117
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05608681A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE).PHASE1 RECRUITING 117 — — Mar 31, 2023Dec 1, 2026Mar 19, 202623 Australia, Canada +4
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Study Endpoints
Primary Endpoints
Dose Escalation- Incidence of treatment emergent adverse events (TEAEs)
52 weeks

TEAEs will be summarized by dose/cohort

Dose Escalation- Severity of treatment emergent adverse events (TEAEs)
52 weeks

TEAEs will be summarized by dose/cohort and severity (mild, moderate, severe).

Dose Escalation- Change from baseline in morning serum cortisol levels
52 weeks

Cortisol will be will be summarized by dose/cohort and over time and compared to pre-dose values. A prolonged and clinically significant reduction in cortisol may indicate adrenal insufficiency.

Dose Escalation- Plasma concentrations of fluticasone propionate
108 weeks

Plasma concentrations of fluticasone propionate over time will be used to calculate PK parameters for each dose/cohort.

Dose Escalation- Change from baseline in physical examination results, BMI and weight change.
12 weeks

Physical examination results, BMI and weight will be summarized by dose/cohort and over time and compared to pre-dose values.

Randomised Dose Optimization- Change from baseline in EoEHSS grade and stage scored in 3 regions of the esophagus within the injection area (proximal, mid, distal)
24 weeks

The EoEHSS scores the stage and grade of 8 histologic items: eosinophil inflammation, basal zone hyperplasia, dilated intercellular spaces, eosinophil abscesses, surface layering, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis), on separate 4-point Likert scales. A composite EoEHSS grade and stage scores are calculated by summing the individual grade and stage items and dividing by the maximum score for evaluated items (range, 0-1). A lower score indicates improvement.

Secondary Endpoints
Dose Escalation- Peak eosinophil count (PEC)
36 weeks
Dose Escalation- Change from baseline in the Straumann Dysphagia Index (SDI) score
52 weeks
Dose Escalation- Change from baseline in dysphagia measured on an 11 point Likert scale
52 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EP-104GI 4 mgEXPERIMENTAL4 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI 8 mgEXPERIMENTAL8 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI 20 mgEXPERIMENTAL8 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI 30 mgEXPERIMENTAL12 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI 48 mgEXPERIMENTAL12 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI 64 mgEXPERIMENTAL16 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI 80 mgEXPERIMENTAL20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI 96 mgEXPERIMENTAL16 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI 120 mgEXPERIMENTAL20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI Dose A or matching vehicle controlPLACEBO_COMPARATOR20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI 160 mgEXPERIMENTAL20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
EP-104GI Dose B or matching vehicle controlPLACEBO_COMPARATOR20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit.
Interventions
NameTypeDescription
EP-104GIDRUGExtended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle
Matching vehicle controlOTHERA sterile liquid containing sterile water and excipients necessary to prepare a uniform suspension of the powder.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Symptomatic EoE; * For women of childbearing potential, a negative pregnancy test and willing to use a highly effective method of birth control until end of study; * Willing and able to adhere to study-related procedures and visit schedule; * Willing and able to provide inform...

Countries:AustraliaCanadaNetherlandsNew ZealandSwitzerlandUnited Kingdom
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Competitive Landscape -Eosinophilic Esophagitis 9 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN1PHASE3Tezepelumab
Regeneron Pharmaceuticals, Inc.REGN3PHASE3dupilumab, Dupilumab
Phathom Pharmaceuticals, Inc.PHAT1PHASE2Vonoprazan
Eupraxia Pharmaceuticals, Inc.EPRX1PHASE1EP-104GI
Sanofi SA Sponsored ADRSNY1 — Dupilumab
Smith & Nephew plc Sponsored ADRSNN1 — Undisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05608681primaryCompletionDate: changed
LOWMay 24, 2026NCT05608681studyFirstPostDate: changed