Axcella Kickstarts Long COVID Phase 2 Clinical Trial

Axcella Therapeutics Inc AXLA has started patient screening in a Phase 2a trial of AXA1125, an oral product candidate, as a potential treatment for Long COVID.

• Phase 2a evaluates the efficacy and safety of AXA1125 in patients with exertional fatigue related to Long COVID. 
• Approximately 40 patients in the U.K. will be enrolled and randomized evenly to receive either 67.8 grams per day of AXA1125 or a matched placebo in two divided doses for 28 days, with a one-week safety follow-up period.
• Related Link: Axcella To Test NASH Candidate In Long COVID Patients.
• The primary endpoint in this Phase 2a trial is the change from baseline to Day 28 in phosphocreatine (PCr) recovery time. 
• In past clinical trials, the highly sensitive and well-established measure of mitochondrial function has been correlated with the six-minute walk test, a registrational endpoint in other conditions involving fatigue. 
• Key secondary endpoints in the Phase 2a trial include lactate levels (a serum marker of mitochondrial dysfunction), six-minute walk test, fatigue scores, and safety and tolerability.
• Top-line data are expected to be reported from the Phase 2a trial in mid-2022.
• Price Action: AXLA shares are up 4.24% at $2.46 during the market session on the last check Thursday.