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Travelan

Phase 2

Diarrhea | Monoclonal antibody | Gastrointestinal |Immuron Limited|Last Updated: Sep 22, 2025

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 Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05933525Clinical Study to Assess the Efficacy of IMM-124E (Travelan®) in a Controlled Human Infection ModelPHASE2 COMPLETED 60 — — May 29, 2023Dec 30, 2024Sep 22, 20251 United States
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Study Endpoints
Primary Endpoints
To measure the protective efficacy of oral administration of Travelan compared to placebo against moderate-to-severe diarrhea following with E.coli (ETEC) challenge.
Monitoring for the Inpatient Study Phase, Study Days -3 to Day 8 or day of dismissal from the clinical trial facility

The number of subjects who encounter moderate to severe diarrhea (defined as ≥4 Grade 3-5 stools in any 24-hour period post-challenge or ≥401 grams of Grade 3-5 stools in any 24-hour period post-challenge) will be recorded for the Travelan group and the placebo group. All stool samples will be collected, weighed and graded. Stool grading scale: Grade 1 = Fully formed (normal) Grade 2 = Soft (normal) Grade 3 = Thick liquid (diarrheal) Grade 4 = Opaque watery (diarrheal) Grade 5 = Rice-water (diarrheal). Diarrhea (Grade 3-5 stools) severity in a 24 hour period (1g = 1ml): 1-mild (2-3 loose/liquid stool totaling \<400 g), 2-moderate (4 to 5 loose/liquid stools or \>401 to 800 g), 3-severe (6 or more loose/liquid stools totaling \>800 g).

Secondary Endpoints
Subjects requiring oral rehydration solution and/or intravenous fluids post ETEC challenge for the Travelan group and the placebo group
Monitoring post challenge on Study Days 1-8 or Day of dismissal from the clinical trial facility.
Density of ETEC organisms in post-challenge stool samples at 48 hours post ETEC challenge for the Travelan group and the placebo group
Monitoring on Study Day 3 or 48 hours post challenge
Safety and tolerability of oral doses of Travelan compared to placebo. Measurement ofthe number of AEs graded as moderate-to-severe (Grade 2-4) for Diarrhea, fever, vomiting and other listed AEs as assessed using the CTCAE v5.0 criteria for AEs.
Monitoring for the inpatient study phase: Study Days -3 to Day 8 or day of dismissal from the clinical trial facility.]
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
TravelanACTIVE_COMPARATORIMM-124E (Travelan) is the investigational product. Travelan 1200mg will be taken orally for 7 days.
PlaceboPLACEBO_COMPARATORProMilk 85 milk powder is the placebo. Placebo has been manufactured into tablets using the same manufacturing process as Travelan. 1200mg will be taken orally for 7 days.
Interventions
NameTypeDescription
TravelanBIOLOGICAL6 Travelan tablets (1200mg) administered orally for 7 days
PlaceboOTHER6 tablets of placebo (1200mg) administered orally for 7 days
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male or female between 18 and 50 years of age, inclusive at time of screening visit. 2. General good health, without significant medical illness, abnormal vital signs or physical examination findings, or clinical laboratory abnormalities, as determined by the principal invest...

Countries:United States
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