By Dean Seal. The trials primary endpoint will assess the improvement of mitochondrial function within the skeletal muscle from baseline to Day 28 as measured by changes in phosphocreatine (PCr) recovery time via 31-phosphorus magnetic resonance spectroscopy (MRS). Intrinsic Value. "This trial is suggesting that a drug that's very safe to take and has minimal side effects is causing substantial improvement in people's physical and cognitive experience of fatigue," said Dr. Jason Maley, a consultant for Axcella who runs a long COVID clinic at Beth Israel Deaconess Medical Center in Boston. 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. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Axcellas pipeline includes lead therapeutic candidates in Phase 2 development for the reduction in risk of overt hepatic encephalopathy (OHE) recurrence, the treatment of Long COVID, and the treatment of non-alcoholic steatohepatitis (NASH). Top-line data are expected to be reported from the Phase 2a trial in mid-2022. It is widely recognized that mitochondrial dysfunction may contribute to the profound fatigue associated with this condition, said lead researcher Dr. Betty Raman, British Heart Foundation Oxford Centre of Research Excellence Clinical Transition Intermediate Fellow from Oxford Universitys Radcliffe Department of Medicine. About Axcella Therapeutics (Nasdaq: AXLA). 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Financial Results. View source version on businesswire.com: https://www.businesswire.com/news/home/20211215005548/en/, University of Oxford jfredette@axcellatx.com Free Case Study Key secondary endpoints include lactate levels, a 6-minute walk test, fatigue scores, and safety and tolerability. cambridge, mass., october 26, 2021--axcella therapeutics (nasdaq: axla), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted. The company has decided that it will focus on the development of AXA1125 targeting long COVID and non . The companys 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. All rights reserved. "Axcella's emerging leadership in therapeutics for Long COVID and NASH make it an exciting time for the company, and I look forward to working with the Axcella management team and Board as we . Their results, though preliminary, are encouraging. In the study, 41 patients were enrolled and received 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. Based on our . Key secondary endpoints include lactate levels, a 6-minute walk test, fatigue scores, and safety and tolerability. This is not surprising given the sheer number of patients impacted by this syndrome, the life-changing symptoms that they are experiencing and the complete absence of treatment options today. https://www.nytimes.com/interactive/2021/world/covid-cases.html The improvement of mitochondrial function in the skeletal muscle from baseline to day 28 as assessed by variations in phosphocreatine (PCr) recovery time will be the trials primary goal. Neuroglee Therapeutics 8,267 followers 2w Report this post We are proud to announce that Neuroglee was selected from hundreds of competing companies as a Rising Star Finalist in the New Health . The company's unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. Axcella plans to use the net proceeds from the offering together with existing cash and cash equivalents to advance the Long COVID program, including regulatory engagement and preparation for . Reuters, the news and media division of Thomson Reuters, is the worlds largest multimedia news provider, reaching billions of people worldwide every day. 1 New York Times. AXLA Valuations. People in the trial conducted at the University of Oxford received either the Axcella drug or a placebo over a period of 28 days. Long COVID is a post-COVID-19 condition referring to the constellation of long-term symptoms that some people experience after . 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. Bill Hinshaw, Axcella President and CEO, noted, Todays announcement further demonstrates the power of our model and is the result of a confluence of events, including the ongoing global pandemic, new findings about Long COVIDs manifestation and drivers, and Axcellas recent scientific, clinical, and regulatory successes with AXA1125. Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile. Please enter a work/business email address. Any forward-looking statements contained in this press release represent the companys views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. What You Will Learn Persistent Symptoms in Patients After Acute COVID-19. Potential to play leading role in addressing Long COVID fatigue and muscle weakness via AXA1125's mitochondrial and bioenergetic impact. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. About 40 patients 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. There are currently no approved treatments for chronic fatigue in patients with long COVID, a condition estimated to affect more than one hundred million people worldwide. CHICAGO, Aug 2 (Reuters) - 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. AXA1125 is a proprietary multi-targeted EMM composition consisting of five amino acids and an amino acid derivative that works via multiple biological pathways. Axcella Therapeutics, a small biotech created by the venture capital firm Flagship Pioneering which 12 years ago birthed the Cambridge-based coronavirus vaccine maker Moderna said the. Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted e . Long COVID Trial Topline data expected in early Q3 2022. The United Kingdoms Medicines and Healthcare products Regulatory Agency (MHRA) accepted a Phase 2a clinical trial authorization (CTA) submission from Axcella on October 22, 2021. Any forward-looking statements contained in this press release represent the companys views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the, Specialty drug launch strategy and operations, The next chapter of clinical trial services, Mucopolysaccharidosis VI (MPS VI) (Maroteaux-Lamy Syndrome ) Global Clinical Trials Review, H1, 2018, Open-Angle Glaucoma Clinical Trial Anaylsis by Trial Phase, Trial Status, Trial Counts, End Points, Status, Sponsor Type, and Top Countries, 2022 Update, Recurrent Glioblastoma Multiforme (GBM) Clinical Trial Anaylsis by Trial Phase, Trial Status, Trial Counts, End Points, Status, Sponsor Type, and Top Countries, 2022 Update, Primary Biliary Cholangitis (Primary Biliary Cirrhosis) Drugs in Development by Stages, Target, MoA, RoA, Molecule Type and Key Players, 2022 Update. A second product candidate, AXA1665, is under investigation in patients with overt hepatic encephalopathy (OHE) in the EMMPOWER Phase 2 clinical trial (NCT04816916). Axcella Health Inc. (AXLA) SEC Filing 8-K Material Event for the period ending Tuesday, November 1, 2022. Axcella (Nasdaq: AXLA) is teaming up with Oxford University on a Phase 2 trial testing out a drug that targets the mitochondria, which is linked to chronic fatigue when dysregulated or damaged.. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Monday. . Conquering the fatigue that strikes 53% of those with long COVID is the goal of biotech Axcella, which is set to begin a trial for its oral candidate. The company's unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. October 27, 2021 Axcella commences trial of AXA1125 for long Covid-19 treatment The trial will evaluate the efficacy and safety of AXA1125 in approximately 40 Long COVID patients. More than 240 million cases of COVID-19 have been reported worldwide to date1, and it is estimated that nearly a quarter of these people suffer from the viruss long-term effects2. By continuing to use our service, you agree to our use of cookies. In September . Clinical Trials - Where are we Headed with COVID-19 Trials? 2020 O: 857-320-2200 F: 617-441 . Promising Results from Phase 2a Placebo Controlled Clinical Trial for Long COVIDPositive Interim Data from Phase 2b EMMPACT Study of AXA1125 in Nonalcoholic Steatohepatitis (NASH)$34.2 Million Registered Direct Offering of Common Stock Priced At The MarketAppointment of Two New Board MembersCAMBRIDGE, Mass.--(BUSINESS WIRE)--Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology . cambridge, mass.-- ( business wire )-- axcella (nasdaq: axla), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (emm) compositions, and researchers at the oxford university radcliffe department of medicine today announced that patient screening is now CAMBRIDGE, Mass., November 01, 2022--Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous . Axcellas platform and each of its clinical programs will be discussed at the companys R&D Day, which takes place today, Tuesday, October 26, starting at 10:00 a.m. EDT. Promising Results from Phase 2a Placebo Controlled Clinical Trial for Long COVID Positive Interim Data from Phase 2b EMMPACT Study of AXA1125 in Nonalcoholic Steatohepatitis (NASH) $34.2 Million . You might "experience long-term adverse effects resembling CFS/ME"that's chronic fatigue syndrome, or myalgic encephalomyelitis"with "symptomatology such as persistent fatigue, diffuse .. Forward-Looking Statements . About Axcella Therapeutics (Nasdaq: AXLA) . Similar to many other conditions and diseases, mitochondrial dysfunction is increasingly being implicated as a key driver of Long COVID-induced fatigue, which is the most common symptom associated with the condition3,4. This global, placebo-controlled trial, also initiated in the second quarter of 2021, is enrolling approximately 150 subjects with a history of OHE for a 24-week treatment period. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. The company sold convertible notes raising $6.0 million to end the quarter with $25.4 million in cash and equivalents. 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 characteristics, competitive position and development potential of AXA1125, the potential for it to address patients unmet needs, and the timing of the companys clinical trial readouts. Axcella's pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID, and NASH. Tools. 9-min read. Source: Axcella Therapeutics. (2021-12-16 | NDAQ:AXLA) Axcella Therapeutics Announces Initiation of AXA1125 Long COVID Phase 2a Clinical Trial. Margaret Koziel, MD, the chief medical officer at Axcella, discussed what long covid is, who is at risk, and how Axcella is testing whether their therapy improves "feeling and function" among people with long covid. Axcella anticipates top-line results from the trial during the middle of next year. Our Standards: The Thomson Reuters Trust Principles. 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 characteristics, competitive position and development potential of AXA1125 and AXA1665, the potential for these product candidates to address patients unmet needs, and the timing of the companys clinical trial initiations and readouts. With no approved Long COVID therapies, the need for continued innovation is urgent. We also use them to share usage . 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 others in the past, it has . The University of Oxford is leading a new a phase 2a clinical trial to investigate whether a drug could treat the fatigue and muscle weakness experienced by many patients who have recovered from COVID. METHODS: An 18-week proof-of-concept study was conducted to assess the safety and efficacy of HTD1801 in PSC. The trial will evaluate the efficacy and safety of AXA1125 in approximately 40 Long COVID patients. Axcella Therapeutics Inc. said Thursday it has closed a $34.2 million direct offering and appointed two new board members, one of whom will be chairman. Email Alerts. Axcella's pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID, NASH, and the reduction in risk of OHE recurrence. Please disable your ad-blocker and refresh. If you have an ad-blocker enabled you may be blocked from proceeding. Reporting by Julie Steenhuysen Axcella Therapeutics Announces Initiation of AXA1125 Long COVID Phase 2a Clinical Trial by Business Wire December 16, 2021 7:28 AM | 7 min read Patient screening underway in the United. Tick the boxes of the newsletters you would like to receive. Research indicates that fatigue is the most common of these symptoms, impacting a majority of Long COVID patients. There is mounting evidence suggesting that infection with the COVID-19 virus can impair the mitochondrias ability to act as the powerhouse of the cell, manifesting in Long COVID fatigue and muscle weakness, said Dr. Alison Schecter, President of R&D at Axcella. IRT plays a crucial role in the success of a Direct-to-Patient trial. id with pleiotropic mechanisms of action. The company explicitly disclaims any obligation to update any forward-looking statements. COVID-19 vaccine maker BioNTech on Monday raised the lower bound of its 2022 COVID-19 vaccine revenue guidance for the full year, citing demand for its adapted shots and higher prices. This global, placebo-controlled trial was initiated in the second quarter of 2021 and is enrolling approximately 270 subjects with biopsy-proven NASH for a 48-week treatment period. cambridge, mass.-- ( business wire )--axcella therapeutics (nasdaq: axla), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted. This provides us with hope that we can make a real difference for tens of millions of patients suffering from this debilitating condition.. How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges, Hard data and deep insights on clinical trials strategy & operations, Receive our newsletter - data, insights and analysis delivered to you. CAMBRIDGE, Mass.-(BUSINESS WIRE)-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 that it will present data on clinical plasma proteomic biomarkers in patients with NASH at the American Association for the Study of Liver . To ensure the most secure and best overall experience on our website, we recommend the latest versions of, https://www.nytimes.com/interactive/2021/world/covid-cases.html, Dr. Betty Raman, Radcliffe Department of Medicine, University of Oxford, United Kingdom (Topic: Long COVID), Dr. Stephen Harrison, Medical Director of Pinnacle Clinical Research, San Antonio, TX and Visiting Professor of Hepatology, University of Oxford, United Kingdom (Topic: NASH), Dr. Eric Lawitz, VP, Scientific and Research Development, The Texas Liver Institute and Clinical Professor of Medicine, University of Texas Health San Antonio (Topic: OHE), Dr. Elliot Tapper, Director, Cirrhosis Program and Associate Professor of Medicine, University of Michigan (Topic: OHE). Through its research commercialization arm, Oxford University Innovation, Oxford is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 200 new companies since 1988.