Our Pipeline
Therapeutic Candidates
We have developed a wholly-owned therapeutic pipeline that today consists of product candidates for three indications: the treatment of nonalcoholic steatohepatitis (NASH), the treatment of Long COVID and liver-related metabolic diseases.
| Product Candidate | Potential Indication | Initial Clinical Studies1 | Therapeutic Development | |
|---|---|---|---|---|
AXA1125
|
Long COVID |
|
Phase 2a Clinical Trial
N=~40, 2 arms, 1 dose
|
|
|
AXA1125
|
Adult NASH |
AXA1125-002
N=32, 1 arm, 1 dose
AXA1125-003
N=102, 4 arms,
1 AXA1125 dose |
EMMPACTSM Phase 2b Clinical Trial
|
|
|
AXA1125
|
Pediatric NASH |
|
||
|
AXA1665
|
Liver-related metabolic disease |
AXA1665-001
N=16, 2 arms, 2 doses
AXA1665-002
N=60, 3 arms, 2 doses
|
EMMPOWERSM Phase 2 Clinical Trial
|
|
Complete
Underway
Planned
Terminated
- Initial Clinical Studies refers to Non-IND Clinical Studies initiated prior to a development path decision.
Pipeline image as of December, 2022.
Check out publications supporting the development of our pipeline
Many publications support the therapeutic application of AXA1125 in long COVID.
View bibliography
Check out our latest publications, presentations and posters
We are publishing innovative research and presenting at leading conferences.
View publicationsOur Clinical Approach
EMMs have a fundamental role in biology and function. Using the Axcella Knowledge Base, Axcella designs and develops novel EMM compositions to engage identified biologies and pathways. Axcella then selects whether to evaluate the candidate in a non-investigational new drug application (non-IND) Clinical Study under U.S. Food and Drug Administration regulations and guidance supporting research with food, or under an IND Clinical Trial. Axcella’s non-IND Clinical Studies evaluate product candidates for safety, tolerability and effects on the normal structures and functions in humans, including in individuals with disease. The company’s non-IND Clinical Studies include a substantial number of biomarkers that may inform biologies relevant to health but are not designed or intended to evaluate a product candidate’s ability to diagnose, cure, mitigate, treat or prevent a disease or other health condition. They are conducted at high-quality medical centers following Good Clinical Practices (GCPs), including Institutional Review Board (IRB) approval, and utilize well-recognized investigators. Using a combination of data from these studies and/or other relevant information, the company decides whether to advance a candidate’s development as a therapeutic or supplement (independently or in partnership), or terminate its development.
To date, Axcella has initially evaluated its product candidates as investigational food products in non-IND Clinical Studies. Axcella has conducted three Phase 2 trials: opened two IND Clinical Trials in the US and received MHRA approval to conduct a Phase 2 trial in the UK.
Axcella has determined its lead compound – AXA1125 – to be a therapeutic product candidate, meaning that all future development of this product will be under Clinical Trials. These Clinical Trials are designed to evaluate the ability to diagnose, cure, mitigate, treat or prevent targeted diseases. The company is targeting long COVID with AXA1125 in Clinical Trials.
This website refers to Axcella’s non-IND Clinical Studies as “Clinical Studies” and its IND- and MHRA-enabled Clinical Trials as “Clinical Trials.”