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BioWorld - Saturday, February 4, 2023
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Home » Playing the long game: Axcella moves toward a global long COVID study
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Playing the long game: Axcella moves toward a global long COVID study

Jan. 24, 2023
By Lee Landenberger
No Comments
Axcella Therapeutics Inc. is working on its comeback to make something else go away. Just before Christmas, Axcella said it was repositioning itself to focus on long COVID-19 and was just granted regulatory guidance on a primary endpoint and study design from the U.K.’s MHRA to conduct a single registration trial of AXA-1125 for those with long COVID fatigue. Axcella will be meeting with the MHRA in the near term to discuss getting an innovative licensing and access pathway application, which is designed to accelerate the approval process. Axcella also has just submitted its IND to the U.S. FDA for a global phase IIb/III study for treating long COVID.
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