Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMM 124-E · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| 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 |
Inclusion Criteria: * Alcoholic hepatitis * Men and women age 21 and above * MELD \>= 20 but \<=28 * About to initiate prednisolone treatment, \< 7 days of steroid treatment, or treatment naive. * Actively consuming alcohol within 6 weeks of entry into the study * Willing and able to comply with st...
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.