Trial Outcomes & Findings for Clinical Study to Assess the Efficacy of Once-daily IMM-124E (Travelan®) in a Controlled Human Infection Model. (NCT NCT05933525)

60 subjects received the challenge strain 3 subjects were dismissed from the study prior to challenge

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 the 5-day 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).

Severe diarrhea defined as 6 or more loose liquid stools in a 24 hour period totaling \>800g. (1g = 1ml). All stools will be collected, weighed (1g = 1ml) 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 severity (Grade 3-5 stools) in a 24 hour period post-challenge (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).

The number of subjects who encounter diarrhea of any severity 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).

Measurement of the number of subjects who require oral rehydration solution and/or intravenous fluids on one or more days post challenge.

Early antibiotic treatment commenced when any of the follow criteria were met and a physician determined it was warranted: 1. Severe diarrhea (Grade 3-5 stools) based on volume (\>800g in 24 hrs) 2. Diarrhea of any severity AND 2 or more of the following symptoms classified as severe (CTCAE v5.0, Grade 3) abdominal pain, abdominal cramps, nausea, arthralgia, fever \>38oC. 3. Any fever \>39oC 4. Subjects who experienced unexpected severe events such as symptomatic hypotension disproportionate to volume loss, renal dysfunction or altered mental state at the discretion of the investigators 5. A study physician determines that early treatment is warranted for other reasons

All AEs will be recorded for the Travelan group and the placebo group using the following criteria (1-4): 1. Diarrhea severity (Grade 3-5 stools) 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). 2. Temperature maximum measured in a 24 hr period: no fever (\<38.0°C), 1-mild (38.0-38.4°C), 2-moderate (38.5-38.9°C), 3-severe (\>39.0°C); 4-Potentially life threatening (\>40oC). 3. Vomiting in a 24 hr period: 0-no episodes, 1-mild (1-2 episodes), 2-moderate (2-3 episodes), or 3-severe (\>5 episodes). 4. Nausea, abdominal discomfort and pain, abdominal cramps, headache, malaise or anorexia graded as follows: 0-Non-existent, 1 -mild (not interfering with routine activities), 2 -moderate (interfering but not precluding routine activities), 3 -severe (precluding routine activities), 4 - potentially life threatening (requires hospitalization)