Axcella Health Inc (NASDAQ: AXLA) stock price surged 53.7% after the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application to start a phase 2b/3 trial in the U.S. for AXA1125, a drug targeted at treating Long COVID Fatigue. The news came out late yesterday after the markets closed, triggering an after-hours rally.
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Investors cheered the FDA’s decision three weeks after Axcella received regulatory guidance from The Medicines and Healthcare products Regulatory Agency (MHRA), the U.K.’s medical regulator, supporting a single trial that could act as the registration trial for patients with Long COVID fatigue.
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Axcella also received regulatory guidance from the FDA regarding the trial created to be the registration trial for patients with Long COVID Fatigue. The company now has regulatory approval from the U.K. and the United States for the trial, which should kick off soon.
The regulatory approvals for the final study came after the company submitted the results of its Phase 2a randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of AXA1125 in patients with fatigue related to Long COVID.
The study results indicated that patients who received AXA1125 showed clinically and statistically significant improvement in physical (p=0.0097) and mental (p=0.0097) fatigue scores compared to placebo subjects.
Axcella’s Ph2b/3 trial will enrol participants who have had fatigue for 12 weeks after being infected by COVID-19. The study will utilise the Chalder Fatigue Questionnaire (CFQ-11) filled out by patients to measure the primary endpoint of improvements in fatigue.
Bill Hinshaw, Axcella Health’s CEO, said:
“We’re excited to now have the regulatory clearance from both the U.S. and U.K. authorities to advance our Long COVID program into a trial that can lead to registration. The guidance from the FDA demonstrates continued progress, following the MHRA milestone a few weeks ago, providing clear next steps in this important, ongoing, and as-yet untreated disease. There are millions of people around the world suffering from Long COVID Fatigue who are without options. Axcella has the leading program in the field, and this regulatory feedback provides the next step in developing a potential Long COVID Fatigue treatment.”
*This is not investment advice.
The Axcella Health stock price surged 53.65% to trade at $0.9262, from Wednesday’s closing price of $0.6028.
