CFS/ME

Tonix Pharmaceuticals Completes Clinical Phase of PREVAIL Proof-of-Concept Study of TNX-102 SL for the Treatment of Fibromyalgia-Type Long COVID

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월요일, 8월 7, 2023
Tonix Pharmaceuticals, Therapy, Arthralgia, Cluster analysis, Sleep, DSM-IV codes, SL, Brain, Infection, COVID, CFS/ME, Bangladesh Technical Education Board, Quality, Pain, Myalgia, Back pain, Translational medicine, Patient, Quality of life, Fibromyalgia, National Institute of Allergy and Infectious Diseases, NIAID, FDA, CFS, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NIH, Food, Fatigue, Pharmaceutical industry, Long COVID

CHATHAM, N.J., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company, today announced the completion of the clinical phase of the Phase 2 proof-of-concept PREVAIL study of TNX-102 SL as a potential treatment for fibromyalgia-type Long COVID. Topline results for the PREVAIL study are expected in the third quarter of 2023.

Key Points: 
  • “Approximately 40% of U.S. Long COVID patients have fibromyalgia-like multi-site pain symptoms based on our observational studies of Long COVID patients from the TriNetX claims database,”2,3 said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
  • We have termed this subgroup, ‘Fibromyalgia-type Long COVID.’ Given our encouraging results with TNX-102 SL as a potential treatment for fibromyalgia4, we are testing TNX-102 SL as a bedtime medicine for the management of Fibromyalgia-type Long COVID.
  • In their recent publication, cluster analysis of the symptom frequencies in the RECOVER study identified four subgroups of Long COVID patients.
  • We believe that daily pain has the potential to be an endpoint for registrational studies in fibromyalgia-like long COVID.”

Tonix Pharmaceuticals Describes Emerging Research on the Incidence of Multi-Site Pain Symptoms in Long COVID Patients During Event Titled, “Long COVID: What Will it Take to Accelerate Therapeutic Progress?”

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수요일, 2월 22, 2023
United States Department of Health and Human Services, CFS/ME, SL, Advocacy group, Chronic pain, Biotechnology Innovation Organization, Assistant, Research, Acceleration, Patient, M.E, Office of the Assistant Secretary for Health, BIO, Tonix Pharmaceuticals, Infection, CFS, Fatigue, Fibromyalgia, Insomnia, COVID, Pharmaceutical industry, Health, Long COVID

CHATHAM, N.J., Feb. 22, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that during a virtual event co-hosted by BIO and Solve M.E. titled, “Long COVID: What Will it Take to Accelerate Therapeutic Progress?”, Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, presented emerging research describing the role of infections in triggering fibromyalgia or CFS/ME and other fibromyalgia-type illnesses, and discussed Tonix’s ongoing Phase 2 study of TNX-102 SL in fibromyalgia-type Long COVID. Symptoms of Long COVID, like multi-site pain, fatigue and insomnia, are the hallmarks of chronic pain syndromes like fibromyalgia and CFS/ME.

Key Points: 
  • Symptoms of Long COVID, like multi-site pain, fatigue and insomnia, are the hallmarks of chronic pain syndromes like fibromyalgia and CFS/ME.
  • “Furthermore, a recent survey2 found comparable pain, fatigue and function between Long COVID, fibromyalgia and CFS/ME.”
    Enrollment continues in the Phase 2 PREVAIL study of TNX-102 SL as a potential treatment for patients with Long COVID syndrome whose symptoms overlap with fibromyalgia.
  • PREVAIL is a randomized, double-blind, placebo-controlled study in the U.S. that is expected to enroll approximately 470 patients.
  • National Research Action Plan on Long COVID, 200 Independence Ave SW, Washington, DC 20201.