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
Long COVID Trial:
Patient enrollment is complete in the prospective, placebo controlled, randomized trial conducted at the
“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
Overt Hepatic Encephalopathy (OHE) Trial:
The company is conducting a global Phase 2 randomized, double-blind, placebo-controlled, multi-center investigation on the efficacy and safety of AXA1665 in OHE. The trial commenced in the second quarter of 2021. Despite investigator interest, this is a rare disease of very ill patients with enrollment challenges and timelines to approval will be long; as a result, the Company has made the decision to terminate the trial and focus resources on both the ongoing Long COVID and NASH programs.
Internet Posting of Information
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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 restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (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 timing of the company’s clinical trial data readouts, its expected cash runway and the potential impact of recent federal memoranda. 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 belief that mitochondrial dysfunction is a key driver of Long Covid induced fatigue, 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 AXA1665 and 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 AXA1665 and AXA1125, the clinical development and safety profile of AXA1665 and AXA1125 and their 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
Source: Axcella Therapeutics