PASC

Virios Therapeutics, Inc. Reaches Alignment with FDA on Requirements for Advancing Development Candidate IMC-2 as Treatment for Long-COVID

Retrieved on: 
Tuesday, January 2, 2024
PASC, Orthostatic intolerance, Food, Medical statistics, FDA, Disease, Conditional sentence, Fatigue, Therapy, Fibromyalgia, Vaccine

The FDA agreed that for the planned Phase 2 proof-of-concept study, Virios can use fatigue as the primary endpoint and orthostatic intolerance as a key secondary endpoint to assess the effectiveness of IMC-2 in treating PASC.

Key Points: 
  • The FDA agreed that for the planned Phase 2 proof-of-concept study, Virios can use fatigue as the primary endpoint and orthostatic intolerance as a key secondary endpoint to assess the effectiveness of IMC-2 in treating PASC.
  • The FDA recommended assessment of a range of IMC-2 doses, including valacyclovir doses above presently approved dosage strengths, to ensure effective inhibition of reactivated herpesvirus.
  • Following the receipt of the FDA’s feedback, Virios is currently exploring options to advance the IMC-2 LC Phase 2 research program.
  • IMC-2 has the potential to be one of the first approved treatments specifically for LC.

Guidance Statement for Mental Health Symptoms of Long COVID Announced by the American Academy of Physical Medicine and Rehabilitation

Retrieved on: 
Wednesday, November 8, 2023
AAPM&R, American Academy of Physical Medicine and Rehabilitation, Selective serotonin reuptake inhibitor, Rehabilitation, Physician, Prevalence, Anxiety, AAPM, Sleep, PM, R, Multimedia, Mental, Dysautonomia, PTSD, Quality of life, Injury, COVID, COVID-19, American Academy, PASC, SAMHSA, Joint, Brain, Spinal cord, Ligament, Depression, Tendon, Physical medicine and rehabilitation, PM&R, Patient, Pediatrics, Mental health, Fatigue, Nursing, Pharmaceutical industry, Medical device, Long COVID, MD

Long COVID can cause new mental health symptoms, worsen existing mental health conditions, or mimic other LC symptoms.

Key Points: 
  • Long COVID can cause new mental health symptoms, worsen existing mental health conditions, or mimic other LC symptoms.
  • Long COVID can cause new mental health symptoms and can also worsen existing mental health conditions or mimic other Long COVID symptoms.
  • "There really is some nuance in looking at the mental health symptoms of Long COVID because Long COVID symptoms that are related to mental health can also exacerbate or mimic other symptoms of Long COVID, such as fatigue, brain fog, and sleep disturbances," said Abby Cheng, MD, FAAPMR, author of the guidance.
  • Traditional nonpharmacologic and pharmacologic mental health treatments, such as SSRIs, should be considered in tandem for treating mental health symptoms of Long COVID.

Scientists detail current evidence that Long COVID is caused by persistent SARS-CoV-2 viral reservoirs

Retrieved on: 
Thursday, September 7, 2023
Infection, University, Therapy, COVID-19, SARS-CoV-2, ME/CFS, Biomarker, Multiple sclerosis, Autoimmunity, Harvard Medical School, Patient, UCSF, Coagulation, Nature Immunology, Viral, Paper, PASC, Alzheimer's disease, Pharmaceutical industry, Vaccine, Long COVID

The paper - written by 33 scientists - is titled "SARS-CoV-2 reservoir in post-acute sequelae of COVID-19 (PASC)."

Key Points: 
  • The paper - written by 33 scientists - is titled "SARS-CoV-2 reservoir in post-acute sequelae of COVID-19 (PASC)."
  • These reservoirs could be one of the primary drivers of the Long COVID disease process.
  • Importantly, the authors emphasize that antivirals or other drugs should be tested in clinical trials with the goal of clearing SARS-CoV-2 reservoirs in Long COVID patients.
  • Publication of the paper makes it clear that top researchers in the Long COVID space are taking SARS-CoV-2 persistence seriously.

Axcella Granted Patent for Long COVID Fatigue Treatment

Retrieved on: 
Tuesday, August 29, 2023
FDA, Health, Infectious Diseases, COVID-19, Pharmaceutical, Biotechnology, 1836 U.S. Patent Office fire, Patent, Senior, Fatigue, Dicarboxylic acid, Candidate, Patient, Biology, Therapy, PASC, NOS, Pharmaceutical industry

11,737,999 with claims covering methods of use of Candidate AXA1125, for treating a subject having post-acute sequelae of COVID-19 (PASC), a/k/a Long COVID, particularly fatigue.

Key Points: 
  • 11,737,999 with claims covering methods of use of Candidate AXA1125, for treating a subject having post-acute sequelae of COVID-19 (PASC), a/k/a Long COVID, particularly fatigue.
  • “Today’s issuance expands our global patent portfolio and Axcella’s protection of its lead candidate, AXA1125,” said Paul F. Fehlner, J.D., Ph.D., Senior Vice President, Chief Legal Officer of Axcella.
  • Axcella was previously granted patents related to AXA1125 with claims covering methods of use and compositions.
  • “We are pleased to have this additional designation as we pursue options to bring our investigational product forward for the benefit of the millions of people who continue to suffer from Long COVID Fatigue.

Virios Therapeutics Announces Positive Data Demonstrating Improvement in Multiple Long-COVID Symptoms Following Treatment with a Combination of Valacyclovir and Celecoxib in an Exploratory, Open-Label, Proof of Concept Study

Retrieved on: 
Monday, July 17, 2023
PROMIS, Myalgia, NRS, Brookings Institution, Arthralgia, Headache, Female, FM, Overalls, Health status of Asian Americans, Celecoxib, BHC, COVID, Doctor of Philosophy, Fatigue, Pain, Food and Drug Administration Amendments Act of 2007, Long COVID, Medical director, COVID-19, Patient, Center of excellence, Dysautonomia, Fibromyalgia, Nausea, Conditional sentence, Diagnosis, Health, Therapy, PASC, Valaciclovir, Food, Post-exertional malaise, Pharmaceutical industry, MD

This open-label, single-center, investigator-initiated study was conducted at the Bateman Horne Center (“BHC”) with an unrestricted investigational grant.

Key Points: 
  • This open-label, single-center, investigator-initiated study was conducted at the Bateman Horne Center (“BHC”) with an unrestricted investigational grant.
  • Treatment with Val/Cel was generally well tolerated, with an observed safety profile consistent with the known safety profiles of valacyclovir and celecoxib.
  • There were no serious adverse events observed in this study and only one treated patient discontinued treatment due to adverse events, possibly related to Val/Cel treatment.
  • “We look forward to engaging the Food and Drug Administration to discuss progressing this novel treatment option into active Phase 2 clinical development.”

Neurological Long COVID Symptoms Guidance Statement Announced by the American Academy of Physical Medicine and Rehabilitation

Retrieved on: 
Tuesday, May 16, 2023
Headache, PM, Tremor, American Academy of Physical Medicine and Rehabilitation, Ligament, Pediatrics, Spinal cord, AAPM, COVID-19, Health equity, Weakness, Quality of life, American Academy, Rehabilitation, Brain, Multimedia, COVID, History, PM&R, DSM-IV codes, Physical examination, AAPM&R, Pain, Occupational therapy, Patient, Physician, Dysautonomia, Joint, Palsy, Diagnosis, Injury, R, Mental health, Neurology, PASC, Physical medicine and rehabilitation, Tendon, Fatigue, Pharmaceutical industry, Hospital, Long COVID

New data suggests antiviral treatments for COVID-19 may help prevent Long COVID, but millions of Americans still suffer from symptoms of Long COVID.

Key Points: 
  • New data suggests antiviral treatments for COVID-19 may help prevent Long COVID, but millions of Americans still suffer from symptoms of Long COVID.
  • "Identifying patients with progressive or ominous "red flag" neurological symptoms is essential for emergent triaging," said Dr. Leslie Rydberg, co-author of the neurology Long COVID guidance statement.
  • "These symptoms may be due to Long COVID versus another medical condition, but a history and physical examination is essential."
  • The American Academy of Physical Medicine and Rehabilitation is the national medical specialty organization representing more than 10,000 physicians specializing in physical medicine and rehabilitation.

New Yale study evaluates PAXLOVID's use in Long COVID recovery

Retrieved on: 
Tuesday, March 21, 2023
Contraindication, Yale School of Medicine, Partnership, Pfizer, Travel, Outcomes research, Infection, Yale Center for Environmental Law & Policy, Quality of life, Data collection, Yale school, Research, Multimedia, Immunity, Evaluation, Immune system, Hugo, Ritonavir, Health, Death, PASC, Long, Pharmaceutical industry, Online shopping, Long COVID, HAVEN, Medicine

Long COVID, also known as post-acute sequelae SARS-CoV-2 infection (PASC), is estimated to affect millions of people worldwide.

Key Points: 
  • Long COVID, also known as post-acute sequelae SARS-CoV-2 infection (PASC), is estimated to affect millions of people worldwide.
  • The study will enroll previously healthy people with fair to poor health as a result of Long COVID.
  • The Yale Center for Infection and Immunity and the Yale Center for Outcomes Research and Evaluation at Yale School of Medicine are collaborating on the study.
  • The research study is enrolling through the Hugo Health Kindred Long COVID community, which is an open and growing community for people interested in research into Long COVID.

Virios Therapeutics Announces Exploratory Long-COVID Trial Top-Line Data, Featuring Combination of Valacyclovir and Celecoxib, Projected in June 2023

Retrieved on: 
Monday, February 13, 2023
PASC, Fatigue, Celecoxib, Memory, Attention, Sleep, Long COVID, Diagnosis, Pain, Center of excellence, Patient, Fibromyalgia, Therapy, Anxiety, Valaciclovir, ME/CFS, Conditional sentence, COVID-19, Pharmaceutical industry

ATLANTA, Feb. 13, 2023 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI), a development-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases including fibromyalgia (“FM”), announced today that it expects top-line results from its Phase 2 Post-Acute Sequelae of COVID-19 (also known as PASC or Long-COVID) exploratory clinical trial to be available in June 2023.

Key Points: 
  • ATLANTA, Feb. 13, 2023 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI), a development-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases including fibromyalgia (“FM”), announced today that it expects top-line results from its Phase 2 Post-Acute Sequelae of COVID-19 (also known as PASC or Long-COVID) exploratory clinical trial to be available in June 2023.
  • This study will assess the potential of the antiviral combination of valacyclovir and celecoxib to provide symptomatic improvements in patients suffering from Long-COVID when added to standard of care therapy.
  • Outcomes being assessed in this study include fatigue, sleep, attention, pain, autonomic function, memory and anxiety.
  • This study is supported via an unrestricted investigational grant to the Bateman Horne Center, a non-profit, interdisciplinary Center of Excellence advancing the diagnosis and treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), fibromyalgia, post-viral syndromes including Long-COVID, and related comorbidities.

New Data Links Modulation of Key Immune-Related Proteins to Improvement of Specific Symptoms in Long COVID

Retrieved on: 
Thursday, February 16, 2023
COVID-19, Research, Infectious Diseases, Biotechnology, Other Health, Health, General Health, Other Science, Science, Biomarker, PASC, Fatigue, NYHA, Trial of the century, Randomized controlled trial, Frontiers in Medicine, Diagnosis, Patient, MRC, Timeline of the COVID-19 pandemic in the United Kingdom, FSS, Medical Research Council (United Kingdom), New York Heart Association Functional Classification, Georgetown University School of Nursing, Medical Research Council, COMPASS, CDC, Survivor, Modified Rankin Scale, DSM-IV codes, Chronic, ME/CFS, Pravastatin, Clinical descriptions of chronic fatigue syndrome, Community, Alternative medicine, Classification, Pharmaceutical industry, Medical imaging, Maraviroc, COVID, Medicine

Data from a new clinical study show modulation of key immune regulating proteins with maraviroc and pravastatin correlates with symptom reduction in patients with post-acute sequelae of COVID (PASC), commonly known as long COVID.

Key Points: 
  • Data from a new clinical study show modulation of key immune regulating proteins with maraviroc and pravastatin correlates with symptom reduction in patients with post-acute sequelae of COVID (PASC), commonly known as long COVID.
  • The study results, published in Frontiers in Medicine, also support a precision medicine approach to diagnosis of long COVID as well as differentiation of long COVID from ME-CFS (myalgic encephalomyelitis/chronic fatigue syndrome), which presents with similar symptoms.
  • Subjective neurological, autonomic, respiratory, cardiac and fatigue symptoms scores all decreased by statistically significant margins.
  • In particular, the FSS (fatigue being the most common symptom) decreased and was closely correlated in decreases of IL-2 and TNF-α.

Aethlon Medical Announces Third Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Monday, February 13, 2023
PASC, Biotechnology, Science, NCI, Infection, Blood, Pfizer, Government, Mpox, Publication, COVID-19, NIH, Safety, ICU, Interest, NAMSA, OSI Pharmaceuticals, UCSF Medical Center, Consolidated, Patient, Biochemistry, Medtech, CSO, Clinical trial, Metastasis, University, Research, University of Waterloo, University of Alberta, Virology, Organic chemistry, Syntex, ATM, Exosome, Plasma, Lung cancer, Internet, SAN, EST, COVID, Biophysics, Drug discovery, Cancer, Doctor of Philosophy, MD, Pharmaceutical industry, Vaccine, Cryptocurrency

SAN DIEGO, Feb. 13, 2023 /PRNewswire/ -- Aethlon Medical, Inc. (NASDAQ: AEMD), a medical therapeutic company focused on developing products to diagnose and treat cancer and life threatening infectious diseases, today reported financial results for its third quarter ended December 31, 2022 and provided an update on recent developments.

Key Points: 
  • SAN DIEGO, Feb. 13, 2023 /PRNewswire/ -- Aethlon Medical, Inc. (NASDAQ: AEMD), a medical therapeutic company focused on developing products to diagnose and treat cancer and life threatening infectious diseases, today reported financial results for its third quarter ended December 31, 2022 and provided an update on recent developments.
  • Financial Results for the Third Quarter Ended December 31, 2022
    As of December 31, 2022, Aethlon Medical had a cash balance of approximately $17.5 million.
  • The Company will hold a conference call today, Monday, February 13, 2022, at 4:30 p.m. EST to review financial results and recent corporate developments.
  • Interested parties without internet access or unable to pre-register may dial in by calling:
    All callers should ask for the Aethlon Medical, Inc. conference call.