Drugs / IMM-124E
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT03042767 | Feb 2017 → Oct 2019 | NAFLD1 | Miriam Vos, MD | Completed | No outcome recorded |
| Phase 2 | NCT02316717 | Dec 2014 → Oct 2017 | metabolic dysfunction-associated steatohepatitis | Immuron Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01968382 | Dec 2014 → Dec 2018 | alcoholic hepatitis | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 2 | NCT01466894 | Dec 2012 → Dec 2013 | metabolic dysfunction-associated steatohepatitis | Immuron Ltd. | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2025-12-09 | Immuron Ltd. | Results Uniformed Services University to Release Topline Data immuron.com.au ↗
Primary Endpoint did not reach statistical significance |
| 2025-01-14 | Immuron Ltd. | Results Immuron Announces Travelan Clinical Trial Update immuron.com.au ↗
Statistically significant lower levels of IgA and IgG were observed for the subjects who received Travelan® compared to those who received the placebo, which may also reflect levels of exposure to ETEC antigen. |
| 2024-03-06 | Immuron Ltd. | Results Travelan to progress to Phase 3 Clinical Trials in the US immuron.com.au ↗
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce the interim topline results confirming that a single daily dose of Travelan® is effective in prevention of moderate to severe diarrhea following challenge with enterotoxigenic Escherichia coli (ETEC). |
| 2023-08-09 | Immuron Ltd. | Regulatory Immuron Receives TGA GMP Clearance immuron.com.au ↗
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce that the Therapeutic Goods Administration (TGA) has given GMP Clearance for Immuron’s packaging supplier allowing Travelan® to be released for sale in Australia to retail pharmacy wholesalers and other customers. |
| 2022-12-22 | Immuron Ltd. | Regulatory Immuron Receives FDA Approval for Travelan IND Application immuron.com.au ↗
The Investigational New Drug (IND) application to evaluate the efficacy of a single dose of Travelan to prevent infectious diarrhea caused by ETEC is now active. |
| 2022-12-04 | Immuron Ltd. | Regulatory Immuron Submits IND Application To FDA for Travelan immuron.com.au ↗
Immuron Submits IND Application To FDA for Travelan |
| 2022-07-26 | Immuron Ltd. | Regulatory Update on IND Application for Campylobacter ETEC Therapeutic immuron.com.au ↗
The IND has been placed on Clinical Hold until the FDA have received and reviewed a response from the NMRC justifying dosing, safety monitoring and a risk mitigation plan. |
| 2021-10-07 | Immuron Ltd. | Results IMM124E Demonstrates Antiviral T-Cell Immunity immuron.com.au ↗ |
| 2021-05-12 | Immuron Ltd. | Results IMM124E May Offer New Modality for Inhibition of SARS-CoV-2 immuron.com.au ↗
Further studies now undertaken, by Monash suggest that the SARS-CoV-2 inhibitory activity is novel and does not bind to the spike protein or the receptor binding domain that the virus |
| 2014-10-14 | Immuron Ltd. | Regulatory NASH & ASH Clinical Trial Update immuron.com.au ↗ |
| 2014-01-22 | Immuron Ltd. | Results Immuron Investor Presentation - January 2014 immuron.com.au ↗
Administration of Imm124-E improved hepatocellular liver enzymes levels p<0.04. |
All press releases naming this drug 12 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IMM-124E | “Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.” NCT01968382 ↗ |
| Modality | Protein / enzyme biologic | “Hyper-immune bovine colostrum enriched with anti-LPS antibodies” NCT01968382 ↗ |
| Route | Oral | “Tablets orally twice a day for 24 weeks” NCT01466894 ↗ |