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Axcella Therapeutics (NASDAQ:AXLA) said patients with Long COVID receiving AXA1125 experienced a clinically and statistically significant improvement in measures of mental and physical fatigue, compared to those on placebo in a phase 2a trial.

The company, however, noted that there was no significant difference on the main endpoint measure of phosphocreatine recovery time (PCrτ) following moderate exercise, between those on AXA1125 and placebo.

The study enrolled 41 people with fatigue related to long COVID, of whom 21 received 67.8 grams per day of AXA1125 and 20 got a placebo, in two divided doses for 28 days, with a one-week safety follow-up period.

The company said clinically meaningful shifts in the severity of physical and mental fatigue were also noted in patients who received AXA1125 compared to those on placebo.

"We are delighted to report that we have meaningful clinical results as well as an increased understanding on the best endpoints for future, potentially registrational studies and look forward to engaging with the regulatory authorities around the next steps in clinical development," said Axcella CEO Bill Hinshaw.

There was a statistically significant correlation of improvement in fatigue score and greater distance achieved in the 6 minute walk test (6MWT) only seen for those on AXA1125, Axcella said in an Aug. 2 press release.

The company added that there was a notable trend toward significant improvement in serum lactate levels after a 6MWT for those receiving AXA1125.

Axcella noted that AXA1125 was safe and well tolerated with no significant adverse events reported by the patients.

Regulatory meetings are planned to discuss a path to a registration trial, the company added.