Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as IMM 124-E (Hyperimmune Bovine Colostrum), Travelan
IMM-124E · 4 trials · 6 indications
Percent change in ALT level from baseline to end of treatment.
Number of events and severity of gastrointestinal events, including nausea, vomiting, and diarrhea
Number of incidents of the following: renal failure, encephalopathy or pulmonary compromise.
Number of incidents of sepsis.
Number of incidents of all other serious adverse events and other adverse events not already assessed as a primary outcome.
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).
Incidence of adverse events per arm/group
Mean change from Baseline in Percentage Fat Content of the Liver measured by Magnetic Resonance Imaging (MRI) at Week 24
Number of patients with treatment-related adverse events
Number of grade 3-5 adverse events
| Arm | Type | Description |
|---|---|---|
| IMM-124E Group | EXPERIMENTAL | Participants with nonalcoholic fatty liver disease (NAFLD) will receive 600mg of IMM-124E powder three times daily for twelve weeks. |
| Placebo Group | PLACEBO_COMPARATOR | Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks. |
| IMM 124-E 2400 mg/day | EXPERIMENTAL | Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily. |
| IMM 124-E 4800 mg/day | EXPERIMENTAL | Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets. |
| Placebo (High protein milk powder) | PLACEBO_COMPARATOR | Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily. |
| 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. |
| Treatment Arm A | EXPERIMENTAL | IMM-124E, 600 mg three times daily, orally plus matching placebo |
| Treatment Arm B | EXPERIMENTAL | IMM-124E, 1200 mg three times daily, orally |
| Treatment Arm C | PLACEBO_COMPARATOR | Matching placebo, three times daily, orally |
| Name | Type | Description |
|---|---|---|
| IMM-124E | BIOLOGICAL | IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring. |
| Placebo | OTHER | Matched Placebo |
| IMM 124-E (Hyperimmune Bovine Colostrum) | DRUG | Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E. |
| Placebo (High protein milk powder) | DRUG | Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily |
| Travelan | BIOLOGICAL | Travelan tablets (1200mg) administered orally once daily for 7 days |
Inclusion Criteria: * Nonalcoholic fatty liver disease (NAFLD) diagnosis confirmed by liver biopsy or MRI * ALT ≥ 2 x ULN at screening (girls ≥ 46, boys ≥ 54) * Written informed parent consent and child assent * Willingness to take IMM-124E or placebo powder 3 x daily for 12 weeks * At least 2 mont...
IMM-124E is being developed for liver diseases, including non-alcoholic steatohepatitis (NASH), nonalcoholic fatty liver disease (NAFLD), and alcoholic hepatitis. It is an investigational therapy and has not been approved for any indication. Clinical studies have enrolled adults with NASH and severe alcoholic hepatitis, as well as children with NAFLD.
IMM-124E targets enteric bacteria, specifically ETEC antigens. It is a hyperimmune bovine colostrum product that contains anti-LPS antibodies, which bind lipopolysaccharide (LPS) on gut bacteria. This mechanism is intended to reduce bacterial endotoxin translocation from the gut to the liver, a pathway implicated in liver inflammation and steatohepatitis.
IMM-124E is developed by Immuron Limited, an Australian biopharmaceutical company listed on the Nasdaq under the ticker IMRN. Immuron is focused on oral immunomodulatory therapies derived from bovine colostrum. The company has conducted Phase 2 clinical trials of IMM-124E in liver disease indications in the United States, Australia, and Israel.
IMM-124E is in Phase 2 clinical development. It is investigational and has not received FDA approval. Three completed Phase 2 trials have evaluated the drug in NASH, pediatric NAFLD, and severe alcoholic hepatitis. No active trials are currently listed for IMM-124E.
IMM-124E has been studied in three completed Phase 2 trials. NCT02316717 evaluated IMM-124E in 133 adults with NASH across the United States, Australia, and Israel. NCT01968382 tested the drug in 57 patients with severe alcoholic hepatitis. NCT03042767 studied anti-LPS antibody treatment in 40 children with NAFLD in the United States.
Yes. IMM-124E, IMM 124-E, and IMM 124-E (Hyperimmune Bovine Colostrum) refer to the same investigational drug developed by Immuron Limited. The different spellings and the descriptive name reflect the drug's composition as a hyperimmune bovine colostrum product containing anti-LPS antibodies.