Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMM-124E · 2 trials · 2 indications
Percent change in ALT level from baseline to end of treatment.
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. |
| 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 |
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 124-E is an investigational drug being studied for the treatment of alcoholic hepatitis, non-alcoholic steatohepatitis (NASH), and nonalcoholic fatty liver disease (NAFLD). It is being developed by Immuron Limited (ticker: IMRN) and is currently in Phase 2 clinical development.
IMM 124-E is a small molecule that targets lipopolysaccharide (LPS), a component of bacterial cell walls. By binding to LPS, it may reduce inflammation and liver damage associated with conditions like alcoholic hepatitis and NASH. This mechanism is being evaluated in clinical trials.
IMM 124-E is being developed by Immuron Limited, a biopharmaceutical company listed on the stock exchange under the ticker IMRN. The company is conducting clinical trials to evaluate the drug's safety and efficacy for liver diseases.
IMM 124-E is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Three Phase 2 trials have been completed, evaluating the drug in patients with alcoholic hepatitis, NASH, and NAFLD.
IMM 124-E has been studied in three completed Phase 2 trials: NCT01968382 for severe alcoholic hepatitis, NCT02316717 for non-alcoholic steatohepatitis, and NCT03042767 for pediatric NAFLD. These trials were conducted in the United States, Australia, and Israel.
Yes, IMM 124-E and IMM-124E refer to the same drug. The name is written with a hyphen in some clinical trial records, such as NCT02316717, and without in others. Both names are used interchangeably in the literature and trial registrations.