Axcella's NASH Candidate Shows Favorable Action In Long COVID-Related Fatigue

• Axcella Health Inc (NASDAQ: AXLA) has reported topline results from the Phase 2a study to evaluate the efficacy and safety of AXA1125 in patients with fatigue related to Long COVID.

• In the study, 41 subjects were enrolled and randomized to receive either 67.8 grams per day of AXA1125 or a matched placebo.

• Subjects who received AXA1125 had improvements in mental and physical fatigue measures that were both highly statistically significant and clinically relevant compared to those who received placebo.

• Mean changes in total, physical and mental scores in the CFQ-11 versus placebo were -4.30, -2.94, and -1.32, respectively.

• Clinically meaningful shifts in physical and mental fatigue severity were also noted in subjects who received AXA1125 than the placebo.

• There was a notable trend toward significant improvement in serum lactate levels after a 6MWT in AXA1125 subjects (p=0.0730). AXA1125 was safe and well tolerated, with no significant adverse events reported by study subjects.

• Price Action: AXLA shares are up 21.10% at $2.35 during the premarket session on the last check Tuesday.

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