Axcella Therapeutics (AXLA) – Regulatory Pathway Clarified for AXA1125

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Friday, February 17, 2023

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Regulatory Pathway Clarified For AXA1125. Axcella announced acceptance of its IND for a Phase 2b/3 trial testing AXA1125 in Long COVID.  As a newly recognized condition with no approved drugs, the requirements for clinical trials and regulatory approval were unknown. We view the announcement as significant milestone that establishes the regulatory pathway for AXA1125 in Long COVID. The proposed trial has been accepted for both US and UK regulatory approval, allowing Axcella to move the program forward.

Conference Call Reiterates Details For Long Covid Trial As anticipated, the FDA and MHRA will accept a single, placebo-controlled study for regulatory approval in the US and UK.  The study will include endpoints to assess mental and physical functions that are common symptoms of Long COVID.  The planned enrollment is about 300 patients, with a treatment period of 3 months.

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