eClinical Technology and Industy News

Axcella Announces Completion of Enrollment of Clinical Trial for Long COVID and Has Prioritized its Clinical Portfolio

  • Long COVID Trial Topline data expected in early Q3 2022
  • NASH Trial interim data expected in late Q3 2022
  • OHE Trial Suspended

Excerpt from the Press Release:

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced that it has prioritized its clinical development portfolio after rapid enrollment for its Phase 2a clinical trial in Long COVID. The company affirmed topline data readout for its Phase 2a Long COVID trial in early Q3 2022 and interim data readout for NASH in late Q3 2022. The company is suspending its Phase 2 clinical trial in OHE (Overt Hepatic Encephalopathy) while exploring potential partnership for the program.

Long COVID Trial:

Patient enrollment is complete in the prospective, placebo controlled, randomized trial conducted at the John Radcliffe Hospital at Oxford University in England. Lead researcher Dr. Betty Raman, British Heart Foundation Oxford Centre of Research Excellence Clinical Transition Intermediate Fellow, said, “We have completed enrollment of the forty patients for this integral study on schedule. We look forward to sharing the results of the trial given the ever growing patient need for a product to address Long COVID fatigue.”

“Achieving completion of enrollment is a significant milestone in the development path of AXA1125 as a potential treatment for Long COVID, a large and growing consequence of the global pandemic,” said Margaret Koziel, M.D., Chief Medical Officer at Axcella. “We believe mitochondrial dysfunction is a key driver of Long Covid induced fatigue. Preclinical and clinical data indicate that AXA1125 may have an important impact.”

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