Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Travelan · 1 trial · 3 indications
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).
| Arm | Type | Description |
|---|---|---|
| Travelan | ACTIVE_COMPARATOR | IMM-124E (Travelan) is the investigational product. Travelan 1200mg will be taken orally once daily for 7 days. |
| Placebo | PLACEBO_COMPARATOR | ProMilk 85 milk powder is the placebo. Placebo has been manufactured into tablets using the same manufacturing process as Travelan. The same dosing schedule of 1200mg will be taken orally once-daily for 7 days. |
| Name | Type | Description |
|---|---|---|
| Travelan | BIOLOGICAL | Travelan tablets (1200mg) administered orally once daily for 7 days |
| Placebo | OTHER | Placebo (1200mg) tablets administered orally once daily for 7 days |
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...
Travelan is an investigational monoclonal antibody being developed for the prevention and treatment of diarrhea, including travelers' diarrhea and infectious diarrhea. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Travelan is being developed by Immuron Limited, a biopharmaceutical company listed on the NASDAQ under the ticker symbol IMRN. The company is conducting clinical trials to evaluate the drug's efficacy in preventing diarrhea.
Travelan is in Phase 2 clinical development. A Phase 2 clinical trial has been completed, and the drug remains investigational. It has not received regulatory approval and is not yet available for commercial use.
Travelan has been studied in a Phase 2 clinical trial registered as NCT05933525. This trial assessed the efficacy of once-daily IMM-124E, also known as Travelan, in a controlled human infection model for diarrhea. The study enrolled 63 participants in the United States.
Yes, Travelan is also known as IMM-124E. In clinical trials, the drug is referred to by both names, with the Phase 2 study NCT05933525 evaluating once-daily IMM-124E, which is marketed under the brand name Travelan.