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Tonix Pharmaceuticals Announces Results of Pre-IND Meeting with FDA for TNX-102 SL as a Potential Treatment for Long COVID Syndrome, Also Known as Post-Acute Sequelae of COVID-19 (PASC)
Company Plans to Submit an IND to Support a Phase 2 Clinical Trial of TNX-102 SL for the Treatment of Long COVID Long COVID Symptoms of Pain, Sleep
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Company Plans to Submit an IND to Support a Phase 2 Clinical Trial of TNX-102 SL for the Treatment of Long COVID Long COVID Symptoms of Pain, Sleep Disturbance, Fatigue and Brain Fog Overlap with Symptoms of Fibromyalgia, for which TNX-102 SL is in Mid-Phase 3 Development Long COVID Afflicts More Than 30% of Patients Following Infection with SARS-CoV-2, the Virus that Causes COVID-19, and is Expected to be a Global Health Burden CHATHAM, N.J., Aug. 24, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it received the official minutes from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-102 SL1 (cyclobenzaprine HCl sublingual tablets) as a potential treatment for Long COVID Syndrome (Long COVID), which is now known officially as Post-Acute Sequelae of COVID-19 (PASC2). Tonix believes the minutes provide a path to agreement on the design of a Phase 2 study and the overall clinical development plan to qualify TNX-102 SL as an indicated treatment for a subset of patients affected by Long COVID. Based on the minutes, the Company is planning to submit the IND in the fourth quarter of 2021 to support a Phase 2 study for the management of a subset of Long COVID patients whose symptoms overlap with fibromyalgia. Seth Lederman, M.D., President and Chief Executive Officer of Tonix, stated, “Long COVID is a new, complex and heterogeneous disorder. Long COVID is a protracted syndrome experienced by many people following SARS-CoV-2 infection that can include a number of persistent disabling symptoms, including fatigue, widespread pain, sleep disturbance, brain fog or difficulty concentrating, arthralgias, diffuse myalgia, olfactory dysfunction, and headache.3 Our Phase 2 study will focus on Long COVID patients whose primary symptoms overlap with fibromyalgia, and, therefore, our Long COVID program leverages what we have learned about the pharmacodynamic activity of TNX-102 SL from more than 1,000 participants who have been or are enrolled in our fibromyalgia trials to date. Long COVID has been compared to fibromyalgia because of the common symptoms of sleep disturbance, persistent widespread pain, fatigue, and brain fog.4 Additionally, Long COVID, lik...