Axcella Announces FDA IND Clearance Supporting Regulatory Path to Registration of AXA1125 for Long COVID Fatigue
Phase 2b/3 study may proceed under
Study design now accepted by
Axcella to present at Long COVID forum co-sponsored by BIO and Solve M.E.
Axcella to host a conference call
The guidance from the FDA and the MHRA follows the company’s submission of materials to both regulatory agencies including results from the Phase 2a randomized, double-blind, placebo-controlled investigation to evaluate the efficacy and safety of AXA1125 in patients with fatigue related to Long COVID. The study found that subjects who received AXA1125 experienced clinically and statistically significant improvement in mental (p=0.0097) and physical (p=0.0097) fatigue scores compared to placebo subjects. Consistent with the Ph2a trial, the Ph2b/3 trial will enroll participants who have had fatigue for at least 12 weeks after COVID-19 infection. The primary endpoint will utilize the same patient reported outcome tool, the Chalder Fatigue Questionnaire (CFQ-11), to measure improvements in fatigue. Additional endpoints will evaluate improvements in physical function, quality of life, and ability to return to work. Participants will receive either placebo or AXA1125 for three months.
“We’re excited to now have the regulatory clearance from both the
“We are pleased to obtain FDA clearance for this phase 2b/3 study, following our positive feedback from the MHRA,” said
“Treatment with AXA1125 resulted in statistically significant improvement in mental and physical fatigue scores, compared to placebo, in a well-designed and carefully conducted randomized controlled trial,” added
“There remains an urgent need for treatment developed specifically for the millions of patients suffering from Long COVID Fatigue, a disease that is having a devastating health and economic impact,” said
Long COVID is a persistent and growing long-term consequence of the pandemic, affecting an estimated one hundred million patients worldwide, with fatigue as the most commonly reported symptom. Recent estimates indicate that 15-20% of Americans with COVID have persisting health issues,i up to four million Americans are out of work due to Long COVID symptoms, and that Long COVID has contributed to approximately
Investor Conference Call Information
Axcella will host a live conference call and webcast at
About Axcella Therapeutics (Nasdaq: AXLA)
Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to reset multiple biological pathways, improve cellular energetics, and restore homeostasis. Axcella’s pipeline includes lead therapeutic candidates for the treatment of Long COVID, NASH, and the reduction in risk of OHE recurrence. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the potential utility of AXA1125 as a treatment of Long COVID and the Company’s anticipated regulatory pathway for AXA1125 and the timing and potential success thereof. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the potential impact of COVID-19 on the company’s ability to conduct and complete its ongoing or planned clinical studies and clinical trials in a timely manner or at all due to patient or principal investigator recruitment or availability challenges, clinical trial site shutdowns or other interruptions and potential limitations on the quality, completeness and interpretability of data the company is able to collect in its clinical trials of AXA1125, other potential impacts of COVID-19 on the company’s business and financial results, including with respect to its ability to raise additional capital and operational disruptions or delays, changes in law, regulations, or interpretations and enforcement of regulatory guidance, whether data readouts support the company’s clinical trial plans and timing, clinical trial design and target indications for AXA1125, the clinical development and safety profile of AXA1125 and its therapeutic potential, whether and when, if at all, the company’s product candidates will receive approval from the FDA or other comparable regulatory authorities, potential competition from other biopharma companies in the company’s target indications, and other risks identified in the company’s
View source version on businesswire.com: https://www.businesswire.com/news/home/20230215005787/en/
Source: Axcella Therapeutics