Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) has received the official minutes of the Type B Pre-Investigational New Drug Application meeting with the FDA to develop TNX-102 SL as a prospective Long COVID Syndrome treatment. Long COVID is officially known as the Post-Acute Sequelae of COVID-19.
Tonix to commence study in Long COVID
The company hopes the minutes will clear the way for an agreement regarding the design of a second Phase study and the general clinical development framework for TNX-102 SL to be approved as an appropriate treatment for a subset of Long COVID patients. According to the minutes, Tonix plans to file an IND in Q4 2021 to enable Phase 2 research for a subset of Long COVID patients with symptoms that overlap with fibromyalgia.
CEO Seth Lederman said, “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. 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 shares the same symptoms with Fibromyalgia
Long COVID is compared to fibromyalgia due to the common symptoms of fatigue, brain fog, sleep disturbance, and persistent widespread pain. Just like Fibromyalgia, Long COVID is more prevalent in women than in men.
Chief medical officer of Tonix Gregory Sullivan said, “Based on our positive fibromyalgia Phase 3 RELIEF study in which TNX-102 SL showed activity in addressing persistent pain, sleep disturbance, memory, fatigue and energy, we are hopeful that TNX-102 SL might provide a unique treatment opportunity for the symptoms of Long COVID in patients whose symptoms overlap with those of fibromyalgia.”