USA: The RECOVER Initiative - Long Covid research

Dakota15 said:
https://twitter.com/user/status/1837210699522576479


https://twitter.com/user/status/1837221063165628823
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While the “multidisciplinary and multi-organ system” approach is good for doctors treating patient symptoms and comorbidities, to me from a research perspective it’s scientists effectively throwing in the towel and saying we’ll never find the root drivers and causes, because the root causes cannot be everything everywhere all at once, it’s a cop out.
 
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Duke Medicine, 9/12/24: 'NIH Awards Dr. Carolyn Glass Grant to Study Long COVID'

'The NIH awarded Associate Professor Carolyn Glass, MD, a $500,000 grant as part of the RECOVER Initiative'

"The two-year grant funding will begin in September 2024. Glass will be part of a national effort that oversees the collection of tissues as well as the prioritization, design, and implementation of best scientific practices for patients recovering from COVID"
 
C&EN: 'NIH plots path forward for clinical trials of long COVID treatments'

'It’s a starting point for resolving what many advocates perceive as a bottleneck'

'if the 3-day meeting the agency just held to discuss the future of its RECOVER initiative is any indication, things are about to shift'

“This should not be a yearlong process,” Marrazzo said. “We need to do this quickly.”

'The urgency is a welcome change for critics of RECOVER'

'NIAID appears likely to green-light multiple types of trials'

“Our lives are at stake. I cannot emphasize this enough,” McCorkell said. “We need to turn this meeting into action.”
 
https://twitter.com/user/status/1839343495691301227


NPR News Now link: https://www.npr.org/podcasts/500005/npr-news-now

NPR: "Researchers and people with Long COVID are meeting this week at the NIH in Maryland. Patient groups and some clinicians say the federal government has been putting too much emphasis on observational studies that don't result in treatments. An estimated 17 million Americans have Long COVID...yet there are still no FDA-approved treatments for this chronic condition. Meighan Stone of the Long COVID Campaign says she's hopeful the NIH meeting is a sign the agency is approaching Long COVID with a new sense of urgency...the NIH is currently deciding how to allocate $515 million to Long COVID research...Stone says the funding should go to clinical trials that takes a patient-centered approach."

Meighan Stone, on NPR: "People living with Long COVID are losing their homes, their losing their careers, their ability to parent, really their lives.."
 
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Foundation for the National Institutes of Health (FNIH) - Team Science Day, 9/16/24:

NIH Director Dr. Monica Bertagnolli: "…where we need so desperately much more fundamental science - that’s Long COVID - we don't have a diagnosis, we have a clinical diagnostic for Long COVID right now based on more than 30,000 people that have been accrued as part of the RECOVER Initiative - but we don't have a lab test - and this disease waxes and wanes and we’re operating in the dark without a fundamental understanding of what that virus is doing to human beings. I can't give you a clear example in a single infectious agent and its effects on us where we're in great shape when we've got the fundamental underpinnings and we're at sea and looking for our way when we don’t."

https://twitter.com/user/status/1839479003993739385
 
Tonix Pharmaceuticals Announces Participation in Endpoints Panel at the Long COVID Workshop and RECOVER TLC Workshop Convened by the Foundation for the National Institutes of Health (FNIH) and the National Institute of Allergy and Infectious Diseases (NIAID)

Tonix’s CEO Dr. Lederman shared perspectives from the development of TNX-102 SL for fibromyalgia and the proof-of-concept Phase 2 study of TNX-102 SL for Fibromyalgia-type Long COVID
CHATHAM, N.J., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman M.D., Chief Executive Officer of Tonix Pharmaceuticals, participated in the “Endpoints” panel at the RECOVER Treating Long COVID (TLC) – Navigating the Pathway Forward workshop hosted by the Foundation for the National Institutes of Health (FNIH) and National Institute of Allergy and Infectious Diseases (NIAID), held September 23-25, 2024, in Bethesda, Md.

The panel, titled “Endpoints,” focused on clinical trial endpoints that could provide meaningful data to support regulatory approval of potential Long COVID therapeutics.

“We were honored to be invited to participate in the Long COVID workshop to discuss the progress of the RECOVER study and to plan the path forward for developing drugs to treat Long COVID,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We welcomed the opportunity to share lessons from our development of TNX-102 SL for Fibromyalgia-type Long COVID, and also for fibromyalgia for which we expect to submit the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in October. Given the urgency of the Long COVID situation, I recommended that the RECOVER-TLC team dialogue with FDA about validating Patient Global Impression of Change (PGIC) as a primary endpoint for therapeutics trials in the context of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)-type Long COVID.”

Dr. Lederman continued, “FDA has already recognized PGIC as a potential endpoint in their recent draft guidance on patient-reported outcomes (PROs). I believe the development of Long COVID drugs should emulate the highly successful regulatory pathway established for cancer drugs. I believe PGIC has the potential to be for Long COVID, what Progression-Free Survival (PFS) has been for new cancer drugs. There are several conceptual similarities that lead me to believe PGIC also could be an appropriate endpoint for accelerated approvals for CFS/ME and Long COVID drugs.”

About the RECOVER Initiative

Millions of Americans suffer from Long COVID. This disease affects each person differently, so no single research study can provide all the answers to Long COVID for everyone. The National Institutes of Health (NIH) created the RECOVER Initiative to find answers across many different types of research studies.

RECOVER brings together clinicians, scientists, caregivers, patients, and community members to understand, treat, and prevent Long COVID. RECOVER has created the world’s most comprehensive and diverse group of Long COVID study participants. For more information can be found at www.recovercovid.org.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and modernizing solutions for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, and its priority is to submit a New Drug Application (NDA) to the FDA in October 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced the U.S. Department of Defense (DoD), Defense Threat Reduction Agency (DTRA) awarded it a contract for up to $34 million over five years in an Other Transaction Agreement (OTA) to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD, instrumental in progressing this development. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

*Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

This press release and further information about Tonix can be found at www.tonixpharma.com.
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Tonix Pharmaceuticals Announces Participation in Endpoints Panel at the Long COVID Workshop and RECOVER TLC Workshop Convened by the Foundation for the National Institutes of Health (FNIH) and the National Institute of Allergy and Infectious Diseases (NIAID) :: Tonix Pharmaceuticals Holding Corp. (TNXP)
 
Todd Davenport on Xitter

“I appreciated the chance to share about post-exertional malaise/post-exertional neuroimmune exhaustion (PEM/PENE) at the RECOVER-TLC workshop. It was a surprise that PEM/PENE was not a focus of the original RECOVER studies, but it was an even bigger surprise that PEM/PENE..."

"...was hardly discussed in any substantive way for the upcoming RECOVER reboot. How NIH handles PEM/PENE will predict the success of the remaining RECOVER efforts. I will be watching what they do. In the meantime, I give the RECOVER-TLC workshop the grade of ‘incomplete.’”

Thanks for including my remarks, @betsyladyzhets in the @thesicktimes newsletter.

https://twitter.com/user/status/1841202521261678656



ETA sick times link
https://thesicktimes.org/2024/10/01...d-to-the-recover-treating-long-covid-meeting/
 
10/2/24: 'Happenings from the September Meeting of NIAID’s Advisory Council'

'Legislative Activities: In June, Dr. Marrazzo participated, along with Dr. Bertagnolli, Dr. David Goff (National Heart, Lung, and Blood Institute Director), Dr. Walter Koroshetz (National Institute of Neurological Disorders and Stroke Director), and Dr. Joe Breen (NIAID Division of Allergy, Immunology, and Transplantation) in a “Lunch and Learn” on Long COVID for congressional staff.'
 
Dakota15 said:
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Dr. Marrazzo: “There probably is persistence of virus. There definitely is immune dysregulation. There definitely is mitochondrial dysfunction, T-cell exhaustion. Probably complement dysregulation, prothrombotic inflammation, and maybe even some dysbiosis in the gut microbiome that may be contributing to breakdown of the gut barrier and the transportation of bacteria that then promotes systemic inflammation.”

Sounds very confident.
 
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