Adriana Valladares
Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering new approaches to complex disease remedy employing compositions of multi-target endogenous metabolic modulators (EMMs), today announced the first effects of the randomized, double-blind, placebo trial. Phase 2a controlled survey to compare the efficacy and protection of AXA1125 in patients with prolonged COVID-related fatigue.
Long COVID is a persistent and developing challenge of the pandemic, affecting approximately one hundred million patients worldwide, with fatigue being the most commonly reported symptom. COVID. In addition, it reported that Long COVID contributed to approximately $1 trillion in profit losses and $529 billion in higher medical expenses.
We believe that the effective remedy of this complex and debilitating disease requires addressing the underlying disruption of multiple biological pathways. Given the lack of remedy features for patients with prolonged COVID and based on our understanding of the positive effect of AXA1125 on mitochondrial function, bioenergetics and inflammation, Axcella conducted a placebo-controlled intervention study in collaboration with clinical researchers at the University of Oxford in an exploratory trial to test speculation that treatment with AXA1125 could improve symptoms of prolonged COVID fatigue. Bill Hinshaw, CHIEF Executive Officer of Axcella, said: “At Axcella, once we learned we had a prospective intervention in prolonged COVID, we acted temporarily to rein in the speculation that we could meet the superior and developing demand that exists for patients living with debilitating fatigue from prolonged COVID. we are extremely pleased to announce that we have significant clinical effects, as well as a greater understanding of the most productive parameters for long-term prospective registry studies and look forward to engaging with regulatory governance around the next steps in clinical development.
Since there are no established endpoints for Long COVID, the study incorporated several endpoints for prioritization, selection, and use in a long-term registration trial to assess the effects of AXA1125 compared to placebo in subjects with moderate to severe fatigue. Safety and tolerance were also studied.
In the study, 41 subjects were recruited and randomized to receive either 67. 8 grams daily of AXA1125 (N = 21) or placebo (N = 20) in two divided doses over 28 days, with a one-week protection follow-up. consistent coniod. The 41 subjects who started the study remained in the study until the end. Endpoints included phosphocreatine recovery time (PCrτ) after moderate exercise, as assessed through 31P magnetic resonance spectroscopy (MRS), which was included to assess mitochondrial function, and, more importantly, clinically applicable endpoints, adding self-reported intellectual and physical fatigue, as assessed through the Chalder Fatigue Questionnaire (CFQ-11), 6-minute walking control (6MWT), as well as serum lactate levels. CfQ-11 is a validated measure of patient-reported fatigue outcomes that has been used to measure the patient’s effect on fatigue states such as chronic fatigue syndrome.
Subjects who won AXA1125 showed innovations in measures of intellectual and physical fatigue that were statistically very significant and clinically applicable compared to those who won placebo. Mean adjustments to total physical and intellectual scores in CFQ-11 compared to placebo were -4. 30 (p=0. 0039), -2. 94 (p=0. 0097) and -1. 32 (p=0. 0097), respectively. Clinically significant adjustments in the severity of physical and intellectual fatigue were also observed in subjects who won AXA1125 compared to those who won placebo. There was a statistically significant correlation between the improvement in fatigue score and a greater distance achieved in 6MWT (p= 0. 0027), an objective measure of physical ability, observed only in subjects who gained AXA1125.
The initial PCrτ among all subjects was particularly higher and had a greater degree of variability between subjects (92. 46 seconds 35. 3 seconds) than in the past reported in the literature. These effects speculate about a significant mitochondrial disorder in these patients, but restrict the usefulness of this parameter in a clinical trial. There was no significant difference in the number one final results of PCrτ after moderate training between subjects receiving AXA1125 and placebo. There was a notable trend towards a significant improvement in serum lactate levels after 6MWT in AXA1125 subjects (p = 0. 0730). AXA1125 was safe and well tolerated with no significant adverse events reported by the subjects examined.
“The statistically significant improvement in intellectual and physical fatigue reported in study participants who received AXA1125 is a very encouraging finding for COVID-19 patients, who suffer from excessive and constant fatigue throughout the day,” said study leader Dr. Julia S. Brown. Betty Raman, Professor asociada. de Cardiovascular Medicine in the Radcliffe Department of Medicine, University of Oxford.
Karim Azer PhD, Vice President of Platform and Discovery at Axcella, said: “The effects of this trial inspire us to further compare the multi-objective effects of AXA1125 on mitochondria and related biomarkers to advance the benefits that axa1125 brings to Patients with Long COVID. The preliminary analysis, which adds studies on biomarkers of the mitochondrial, inflammatory and endothelial environment, provides additional data that reinforce the basic justification for the compelling clinical benefits of axa-1125.
Dr Jason Maley, director of the Critical Illness and COVID-19 Survival Program at Beth Israel Deaconess Medical Center, said: “This is the first pharmaceutical agent to demonstrate advanced results for patients with prolonged COVID in a randomised controlled trial and suggests that AXA1125 possibly plays a vital role in the long-term remedy of those patients as they seek to return to the life they had before infection. On behalf of the countless patients urgently seeking treatments for the debilitating symptoms of Long COVID, I am extremely happy to see the continued progression of AXA1125. “
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About Axcella Therapeutics (Nasdaq: AXLA) Axcella is a clinical-stage biotechnology company pioneering a new technique for treating complex diseases that employs endogenous metabolic modulator (EMM) compositions. The company’s product applicants are comprised of EMMs and derivatives that are designed in separate combinations and proportions to repair cellular homeostasis in several key biological pathways and improve cellular energy efficiency. The Axcella pipeline includes leading curative candidates in Phase 2 progression for the treatment of prolonged COVID and nonalcoholic steatohepatitis (NASH). The company’s unique style allows the evaluation of its EMM Compositions through non-IND clinical studies or IND clinical trials. For more information, stop at www. axcellatx. com.
Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the interest that may be held in product applicants. or the securities of the Company. following the announcement of the effects of the company’s recent clinical trials and the timing of the company’s clinical trial data readings and next steps in its clinical programs, adding a prospective registration trial of AXA1125 for the treatment of prolonged COVID. The words “possibly”, “will”, “could”, “deserve”, “deserve”, “expect”, “plan”, “anticipate”, “intend”, “believe”, “estimate”, “predict”, “project”, “prospective”, “pursue”, “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements involve such identifying words. All forward-looking statements included in this news release are based on management’s existing expectations and confidence and are subject to a number of significant risks, uncertainties and issues that could cause actual events or effects to differ. differ materially from those expressed or implied by any forward-looking statement. statements in this press release, adding but not limited to those similar to the belief that mitochondrial disorder is a key driving force of prolonged COVID-induced fatigue, the possible influence of COVID-19 on the company’s ability to drive and all of its ongoing or planned clinical studies and clinical trials in a timely manner or not at all due to recruitment or availability problems of patients or principal investigators, clinical trial site closures or other interruptions and prospective limitations in the quality, integrity and knowledge interpretation ability the Company may gather in its clinical trials of AXA1125, other possible effects of COVID-19 on the Company’s business and monetary effects, aggregating with respect to its ability to raise further capital and operational disruptions or delays, adjustments in the law, regulations or interpretations and application of regulatory guidance, whether whether the knowledge readings assist the Company’s clinical trial plan and schedule, clinical trial design and target indications for AXA1125, clinical progression and protection profile of AXA1125 and its prospect of cure, if and when, if any, applicants for the Company’s products will obtain approval from the FDA or other comparable regulatory authorities, prospective festival from other biopharmaceutical corporations on the target indications and other known hazards in corporate filings with the SEC, adding Axcella’s annual report in the Form 10-K, quarterly reports on Form 10-Q, and upcoming filings with the SEC. The Company cautions you not to place undue reliance on forward-looking statements, which speak only as of the date they are made. Axcella disclaims any legal responsibility to publicly update or revise such statements to reflect any restatement in expectations or the occasions, situations or instances on which such statements may be based, or the likelihood that actual effects may differ from established ones. in forward-looking statements. All forward-looking statements included in this press release constitute the company’s outlook only as of the date hereof and should not be relied upon as constituting its outlook as of any future date. The Company expressly disclaims any legal responsibility to update any forward-looking statements.
Dr. Maley receives reimbursement as a representative of the Society.
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