Product Description
AXA1125 is an EMM composition of six amino acids and derivatives. This product candidate has shown the potential to effect pathways related to metabolism, inflammation and fibrosis in NASH. BCAAs can promote glucose uptake, increase insulin sensitivity, and decrease lipotoxicity. Arg functions to reduce ammonia and liver cell damage. Gln and Arg also may reduce inflammation through their impact on gut epithelial cells. Additionally, Nac works as an anti-inflammatory agent by promoting glutathione synthesis and reducing reactive oxygen species (ROS). (Sourced from: https://axcellatx.com/pipeline/axa1125/)
Mechanisms of Action: Amino Acid Metabolism Modulator
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Fast Track - Non-alcoholic Steatohepatitis *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Axcella Health
Company Location: CAMBRIDGE MA 02139
Company CEO: William R. Hinshaw
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Highest Development Phases
Phase 2: Communicable Diseases|Post Acute COVID-19 Syndrome|Hepatitis, Alcoholic|Hepatitis A|Non-alcoholic Steatohepatitis|Liver Cirrhosis|Fatty Liver, Alcoholic
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| EMMPACT | P2 |
Unknown status |
Hepatitis, Alcoholic|Liver Cirrhosis|Fatty Liver, Alcoholic|Non-alcoholic Steatohepatitis |
2023-09-01 |
|
| EMMPACT | P2 |
Terminated |
Non-alcoholic Steatohepatitis|Hepatitis, Alcoholic|Hepatitis A |
2022-12-14 |
|
| AXA1125-201 | P2 |
Completed |
Post Acute COVID-19 Syndrome|Communicable Diseases |
2022-06-21 |
|
| AXA1125-003 | N/A |
Completed |
Non-alcoholic Fatty Liver Disease|Liver Diseases, Alcoholic|Fatty Liver, Alcoholic |
2020-03-31 |