These decreases are primarily the result of lower non-cash stock-based compensation expenses. All subjects experienced significantly greater changes from baseline in MRI-PDFF at 12-weeks compared to the change from baseline in the placebo group (placebo adjusted difference of -18.98% (p=0.0082) and -21.24% (p=0.0014) for the low and high doses, respectively). In addition, the company provides COVID-19 testing solutions. Interest income (expense) and other income (expense), net. The goal is to take this forward as rapidly as possible, the medical chief said, with the CEO anticipating the regulatory talks to be a favorable discussion. While the endpoints are yet to be hashed out, Koziel expects general quality of life and improvements in physical activities to be studied in the trial. Add the following snippet of code to the top of your .htaccess file: # BEGIN WordPress In this example the file must be in public_html/example/Example/. RewriteBase / The study did not test for all types of long COVID conditions, but researchers found there were 2.3 fewer cases per 100 people of long COVID conditions, including heart disease, blood disorders, fatigue, liver disease, kidney disease, muscle pain, thinking impairments and shortness of breath, three months after their COVID diagnosis. The easiest way to edit a .htaccess file for most people is through the File Manager in cPanel. Phase 2a evaluates the efficacy and safety of AXA1125 in patients with exertional fatigue related to Long COVID. Long Term Care and Post-Acute Care Providers Multi-System Inflammatory Syndrome (MIS) Associated with COVID-19 Outpatient Providers COVID-19 Public Health Net Loss: Net loss for the quarter and nine months ended September 30, 2022 was $17.8 million, or $0.34 per basic and diluted share, and $58.2 million, or $1.19 per basic and diluted share, respectively. Please note the magic link is Axcella Health Inc AXLA has announced a new clinical program investigating AXA1125 as a potential treatment for patients with Long COVID. And Monday evening, execs put out word that the FDA has upped the ante one more time putting a damper on any lingering hopes for a Q1 approval by the PDUFA date next year. At its core, Bristol Myers claimed that Gileads pioneering CAR-T, Yescarta, infringed on its patent relating to the composition of a chimeric antigen receptor the CAR in CAR-T that can be genetically engineered into a T cell. G&A Expenses: General and administrative expenses for the quarter and nine months ended September 30, 2022 were $3.8 million and $12.3 million, respectively. One of the first trials aimed at tackling long Covid helped some patients recover from lingering physical and mental fatigue, although the drug developed by Axcella Health Inc You may get a 404 error for images because you have Hot Link Protection turned on and the domain is not on the list of authorized domains. Axcella Therapeutics is a biotech company based in Boston and they are currently working in collaboration with Oxford University on Some 89% of those living with long Covid in Ireland have not returned to their previous level of health, a survey found. Either way, please contact your web host immediately. As long Covid impacts millions of people, the biopharma industry has only a dozen or so companies looking at the condition. Axcellas pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and NASH. Before you do anything, it is suggested that you backup your website so that you can revert back to a previous version if something goes wrong. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The search identified 28 557 records, of which 13 577 records were screened; 299 records were also identified via other methods. SVB Securities analysts pegged AXA1125 with a 45% probability of success at getting approved in long Covid. As Covid-19 cases mount once again and millions of people experience lingering symptoms months after diagnosis, Axcella Therapeutics wants to treat long Covid, but like Given the lack of therapeutic options for Long COVID patients and based on our understanding of AXA1125s positive impact on mitochondrial function, bioenergetics, and Long COVID is a persistent and growing challenge of the pandemic, affecting an estimated one hundred million patients worldwide, with fatigue as the most common symptom. Trial Design and Oversight. In a near-first for the biotech industry, Axcella Therapeutics Inc. is launching a clinical study investigating a new drug to treat "long Covid," a long-lasting version of the once Axcella Therapeutics announced it is initiating a new clinical program to study AXA1125 in patients with Long Covid, also called Post COVID-19 Condition and Post-Acute Sequelae of COVID-19 (PASC). Sensorium Therapeutics put out word of its launch and subsequent Series A Tuesday morning, looking to work in psychoactive drugs with an emphasis on mental health, such as anxiety and depression. In this interim analysis, at 24-weeks there were statistically significant improvements in the liver stiffness measurement (LSM) using vibration-controlled transient elastography compared to placebo in the high dose arm for all subjects. The PCr is used to assess improvement of mitochondrial function, which creates most of the chemical energy, in the so-called powerhouse of the cell in skeletal muscle. Background: Aerosolized medications are frequently administered across the health care continuum to acutely ill patients. Just click. We'll e-mail you a link to set a new password. As part of the registered direct offering, the $6.0 million convertible notes automatically converted into the Company's common stock. Please note this link is one-time use only and is valid for only 24 hours. Addressing long COVID will be critical to individual and community health and our collective recovery from the pandemic. The mean change in total fatigue score versus placebo was -4.30, good for a p-value of 0.0039. Medikamente gegen Long Covid, also andauernde Beschwerden nach Abklingen der eigentlichen Covid-19-Erkrankung. Hexagon Bio has so far raised $67 million in a new round, the company confirmed to Endpoints. More than two years ago, BioMarin went into a version of corporate shock when the FDA demanded to see two years of follow-up data from its Phase III trial ahead of a marketing decision for its hemophilia A gene therapy valoctocogene roxaparvovec (valrox). Fatigue is a major concern for patients who experience the lingering effects of Covid-19. By these metrics, patients that took Paxlovid were 26% less likely to develop long COVID. as well as hereditary cancer testing. -, Axcella to Present at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting, Chardan Lowers PT for Axcella Health to $5 From $7, Citing 'Greater Dilutionfrom Future Modeled Capital Raises', Maintains Buy Rating, AXCELLA HEALTH INC. Management's Discussion and Analysis of Financial Condition and Results This randomized, double-blind, placebo-controlled, parallel-group trial was conducted at 143 sites in 16 countries. Axcella Health Inc. published this content on 01 November 2022 and is solely responsible for the information contained therein. In this example the image file must be in public_html/cgi-sys/images/. (RTTNews) - Axcella Therapeutics (AXLA) on Tuesday reported positive topline results from the Phase 2a study of its drug candidate AXA1125 in patients with fatigue related to Long Covid. The company will report second quarter earnings in the coming weeks. Axcellas net loss for the quarter and nine months ended September 30, 2022, was $17.8 million, or $0.34 per basic and diluted share, and $58.2 million or $1.19 per share, respectively. The trial will target patients with long Covid To get to this finding, the researchers combed through electronic health records from more than 56,000 patients in the VA health system who tested positive for COVID-19 between March and June 2022, and had at least one risk factor for severe disease. The study involved 988 participants. During viral pandemics, the World Health Organization and The collaboration between AAV gene therapy developers and CDMOs has resulted in scalable manufacturing solutions to transition a gene and a dream into a biological therapeutic poised for successful patient outcomes and a greater number of commercialized treatments. Price Action: AXLA shares are up 4.24% at $2.46 during the market session on the last check Thursday. Axcella noted its impact on the workforce, citing recent congressional subcommittee data that say almost one in five adults with Covid will go on to have long Covid, and that about one million Americans are out of work because of the condition. Axcella Therapeutics Inc (NASDAQ: AXLA) has started patient screening in a Phase 2a trial of AXA1125, an oral product candidate, as a potential treatment for Long COVID. If not, correct the error or revert back to the previous version until your site works again. If the drug makes it into a Phase III study in long Covid, the biotech thinks it can be efficient and will then work with the right parties to help us develop and capitalize the company, Hinshaw said. At a glance. warns against voter fraud, November is Subscriber Appreciation Month, Cross country state roundup: Trio of South Sound runners seize titles. Skip To Main Content. Promising Results from Phase 2a Placebo Controlled Clinical Trial for Long COVID Positive Interim Data from Phase 2b EMMPACT Study of AXA1125 in Nonalcoholic | November 1, 2022 Copyright 2022 Surperformance. Ateas antiviral, AT-527, failed a mid-stage test last year, and the company subsequently ditched a six-month follow-on study looking at the drugs impact on long Covid in up to 1,000 patients. The trial also looked at blood tests measuring lactate, a sign of muscle health, as well as patient-reported measures of mental and physical fatigue. A drug made by Axcella Health, originally developed to treat fatty liver disease, showed promise in a small study of 41 subjects. About Axcella Therapeutics (Nasdaq: AXLA). Axcella Therapeutics Inc (NASDAQ: AXLA) has started patient screening in a Phase 2a trial of AXA1125, an oral product candidate, as a potential treatment for Long COVID. Axcellas pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH). Trial Design and Oversight. A new startup on the West Coast wants to tackle chronic diseases and age-related conditions, and its trying to do so using the world of secreted proteins.. Axcella to Present at the American Association for the Study of Liver Diseases (AASLD) .. Chardan Lowers PT for Axcella Health to $5 From $7, Citing 'Greater Dilutionfrom Future.. AXCELLA HEALTH INC. Management's Discussion and Analysis of Financial Condition and Re.. Transcript : Axcella Health Inc., Q3 2022 Earnings Call, Nov 01, 2022. Biogen Outlines Aduhelm's Confirmatory Trial Plans, Data Expected In 2026, Seres Posts Interim Microbiome Data Analysis From Failed Ulcerative Colitis Study. It is also possible that you have inadvertently deleted your document root or the your account may need to be recreated. No patients in the trial had been on any other Covid-19 therapies, she said. Regarding the primary outcome, Axcellas medical chief said the drug developer was expecting baseline PCr to be around 50 seconds, but the figure was sky-high in the patients who actually took part in the study, conducted in conjunction with the University of Oxford. The study did not test for all types of long COVID conditions, but researchers found there were 2.3 fewer cases per 100 people of long COVID conditions, including heart Some 89% of those living with long Covid in Ireland have not returned to their previous level of health, a survey found. This compares with a net loss of $15.6 million, or $0.41 per basic and diluted share, and $46.7 million, or $1.23 per basic and diluted share, for the quarter and nine months ended September 30, 2021. Financial Stability. Axcella's pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID, and NASH. Absolute changes in LSM were 0.13, -2.01, and -4.07 kilopascals (kPa) in the placebo, low dose and high dose arms, respectively (p= 0.0992 and 0.0096 for the low and high dose, respectively, compared to placebo). Bioscience & Technology Business CenterThe University of KansasLawrence, Kansas. This included the release of top-line results in Long COVID and an interim analysis of the Phase 2b EMMPACT trial in NASH. Mean changes in total, physical and mental scores in the CFQ-11 versus placebo were -4.30 (p=0.0039), -2.94 (p=0.0097) and -1.32 (p=0.0097), respectively. All were more than 12 weeks post COVID infection and had an abnormal phosphocreatine recovery time, a measure of mitochondrial function. The treatment prospect will be compared against placebo in about 40 patients in the U.K. twice a day for 28 days starting later this year. Instead, the baseline value was 92 seconds, which is like people who have severe peripheral arterial disease, like they are not getting blood flow to their lower legs, Koziel said. Benzinga does not provide investment advice. /index.php [L] Others who received the drug also reported physical and mental improvements that were deemed to be statistically significant as shown on a scale developed to measure chronic fatigue, according to the preliminary results, and the drug was shown to be safe and well tolerated. Statistically significant improvements in alanine aminotransferase (ALT) were seen at both weeks 12 and 24 in all subjects (placebo-adjusted difference of -28.61% (p=0.0183) and -36.3% (p=0.0017) for the low and high doses, respectively). In the latest setback for Bristol Myers Squibb in a years-long legal tussle with Gilead over a CAR-T patent, the Supreme Court of the United States has declined to hear its petition to revive a $1.2 billion verdict. Axcella expects that its current cash balance will be sufficient to meet its operating needs into the second quarter of 2023, provided that, if the Company is unable to satisfy the cash covenants contained in its loan and security agreement with SLR Investment Corp., and SLR Investment Corp. seeks immediate repayment of the loan in full, the Company believes that its cash and cash equivalents will be sufficient to fund its operations into the late first quarter of 2023. The company rapidly achieved its enrollment target in the study. Any forward-looking statements contained in this press release represent the company's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Approximately 40 patients in the U.K. will be enrolled and randomized evenly to receive either 67.8 grams per day of AXA1125 or a matched placebo in two divided doses for 28 days, with a one-week safety follow-up period. Juvena Therapeutics emerged with a $41 million Series A on Monday morning, nabbing Mubadala Capital the UAEs sovereign wealth fund and Horizons Ventures as its lead investors. You'll have to wait, 911 call made from Apple Watch of Washington woman buried alive released, Tyson Foods CFO arrested after drunkenly entering random woman's home and sleeping in her bed, police say, Jackson, in dissent, issues first Supreme Court opinion, Rapper Hurricane G dies at 52 after battle with lung cancer, Heavy rain, snow coming to SoCal on Tuesday, Below-average start to early voting, D.A. 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 expected benefits of Mr. Rosiello's and Mr. Straight Nissen's service on the Board of Directors of Axcella. In past clinical trials, the highly sensitive and well-established measure of mitochondrial function has been correlated with the six-minute walk test, a registrational endpoint in other conditions involving fatigue. In the 41-patient pilot study released on Tuesday, for three of 21 patients who received the drug, AXA1125, their physical fatigue scores returned to normal levels after 28 days of treatment, Axcella Chief Medical Officer Margaret Koziel said in a phone interview. One of the first trials aimed at tackling long COVID helped some patients recover from lingering physical and mental fatigue, although the drug developed by Axcella Health Inc The biotech thinks clinically and statistically significant improvements in self-reported mental and physical fatigue can get the drug toward the finish line, as there are no currently approved treatments for the pandemic diseases long-term impacts. Notice that the CaSe is important in this example. Axcella share prices increased by 20% between the news release Tuesday morning and market close on Wednesday. Axcella Health Inc. (AXLA) SEC Filing 8-K Material Event for the period ending Tuesday, November 1, 2022. For the study's primary goal, there was no statistically significant difference between the groups on phosphocreatine recovery time. The companys unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. The types of confounders that often lead to long Covid and Covid, in general, are often characterized in the NASH population, so we already know that its working preclinically and clinically in that setting based on our previous data, so this gives us a lot of optimism and confidence as we go forward, CEO Bill Hinshaw said in a joint interview. See the Section on 404 errors after clicking a link in WordPress. People in the trial conducted at the University of Oxford received either the Axcella drug or a placebo over a period of 28 days. JAMA. About. At a glance. At the end of March, Axcella had about $63 million at its disposal. Simultaneous with the financing, the company appointed Robert Rosiello and Torben Straight Nissen to its Board of Directors, and Mr. Rosiello also became Chairman of the Board. Almost a year after the FDA cleared their sickle cell disease program for a first-in-human trial, the base editing experts at Beam Therapeutics are still working on enrolling their first patient. Axcella Therapeutics Inc (NASDAQ: AXLA) has started patient screening in a Phase 2a trial of AXA1125, an oral product candidate, as a potential treatment for Long COVID. On platforms that enforce case-sensitivity example and Example are not the same locations. 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. The company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Axcella Therapeutics Inc AXLA has started patient screening in a Phase 2a trial of AXA1125, an oral product candidate, as a potential treatment for Long COVID.. When you have a missing image on your site you may see a box on your page with with a red X where the image is missing. Cambridge, Mass., November 1, 2022 - Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced financial results for the third quarter ended September 30, 2022 and provided a business update. Beam announced in its Q3 update that its pushing back plans to file an IND in 2022 for BEAM-102, which takes an alternative approach to treat the genetic blood disorder. Notice that the CaSe is important in this example. From private practice and health system leaders to scientists and public health officials, hear from the experts in medicine on COVID-19, monkeypox, medical education, advocacy issues, burnout, vaccines and more. The biotech isnt giving up on the pandemic diseases long-term effects, unlike the move that PureTech Health made after missing the beat in its own Phase II last month. While Omicron and other variants and sublineages of the coronavirus have limited the impact of vaccines and therapies, Axcella doesnt expect that to be the case for AXA1125 in long Covid. Pioneering a new approach to treating complex diseases and supporting health using Endogenous Metabolic Modulators (EMMs). The drug, originally developed for fatty liver disease, aims to treat the crushing chronic fatigue reported by more than half of long COVID sufferers by restoring normal function of mitochondria, the minuscule power plants that help cells perform properly. The median age of patients was 43 years old and, to be enrolled, the patients had to have severe fatigue for at least three months, CMO Margaret Koziel told Endpoints News. Symptoms last for months Look for the .htaccess file in the list of files. "Through the third quarter, we made important progress in our clinical development of AXA1125 and strengthened our balance sheet with a new financing. Intrinsic Value. Nov. 17, 2020, 02:22 PM TipRanks 2d.NIO Stock This randomized, double-blind, placebo-controlled, parallel-group trial was conducted at 143 sites in 16 countries. The researchers evaluated 1,459 people living with Long COVID who were part of the Zoe Health People in the trial conducted at the University of Oxford received either the Axcella drug or a placebo over a period of 28 days. This will reset the permalinks and fix the issue in many cases. The properties will tell you the path and file name that cannot be found. ", Mr. Hinshaw continued, "As the company advances toward late-stage clinical trials, we are pleased to have the additions of Mr. Rosiello and Mr. Straight Nissen to our Board, whose extensive leadership experience will help guide Axcella as we focus on taking steps toward delivering these treatments to patients.". 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