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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 ...
Tonix Pharmaceuticals Announces Participation in Endpoints Panel at the Long COVID Workshop and RECOVER TLC Workshop Convened by the Foundation for the
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"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) \n 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\nCHATHAM, 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...