- Axcella Therapeutics ( NASDAQ: AXLA ) is trading ~16% higher post-market after the U.S. Food and Drug Administration cleared its Investigational New Drug ( IND ) application to begin a phase 2b/3 trial in the U.S. for AXA1125 to treat long COVID fatigue.
- The study design now has acceptance from both the U.S. and U.K. regulatory authorities.
- A study found that subjects who received AXA1125 experienced clinically and statistically significant improvement in mental and physical fatigue scores compared to placebo subjects.
- The Ph2b/3 trial will enroll participants who have had fatigue for at least 12 weeks after COVID-19 infection.
- It will also evaluate improvements in physical function, quality of life, and ability to return to work. Participants will receive either placebo or AXA1125 for three months.
- Press Release
For further details see:
Axcella rises 16% after receiving FDA clearance for long COVID fatigue treatment trial