Shares of Tonix Pharmaceuticals were up nearly 11% in premarket trading after the company announced plans to initiate a Phase II study of TNX-102 SL as a potential treatment for Long COVID Syndrome following a positive meeting with the U.S. FDA.
Shares of Tonix Pharmaceuticals were up nearly 11% in premarket trading after the company announced plans to initiate a Phase II study of TNX-102 SL as a potential treatment for Long COVID Syndrome following a positive meeting with the U.S. Food and Drug Administration (FDA).
New Jersey-based Tonix said the Type B meeting with the FDA provides a clear path for the design of the Phase II study, as well as an overall clinical development plan for TNX-102 SL (cyclobenzaprine HCl sublingual tablets). Long COVID, also known as Post-Acute Sequelae of COVID-19, is associated with multiple symptoms, including fatigue, poor sleep, brain fog, and symptoms of fibromyalgia, for which TNX-102 SL is in an ongoing Phase III study. Tonix said it will submit an Investigational New Drug Application to the FDA in the fourth quarter of this year for the study, which will include a subset of patients who are experiencing the fibromyalgia-like symptoms.
Seth Lederman, president and chief executive officer of Tonix, said Long COVID is a complex and heterogeneous disorder. It is estimated that more than 25% of COVID-19 patients experience Long COVID. It is generally associated with moderate or severe COVID-19 infection, but it can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infections. As the virus continues to ravage its way across the globe, Long COVID is expected to become a global health burden, Lederman said. He said the Phase II study will leverage what Tonix has already learned about pharmacodynamic activity of TNX-102 SL from the fibromyalgia trials.
“Long COVID has been compared to fibromyalgia because of the common symptoms of sleep disturbance, persistent widespread pain, fatigue, and brain fog. Additionally, Long COVID, like fibromyalgia, is experienced by women at a rate approximately four times that of men. The 2003 SARS outbreak, due to an earlier coronavirus, was also described as causing a post-SARS syndrome similar to fibromyalgia,” Lederman said in a statement.
TNX-102 SL is a sublingual form of cyclobenzaprine hydrochloride. The drug is designed to provide rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism, according to the company. TNX-102 SL binds and blocks serotonin 2A, alpha1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors. It is being developed as a daily bedtime treatment for fibromyalgia, PTSD, alcohol use disorder and agitation in Alzheimer’s disease. Lederman noted that the proposed mechanism of TNX-102 SL is to improve sleep quality. The company will determine if TNX-102 SL improves sleep in these patients.
Gregory Sullivan, chief medical officer at Tonix, said data from the Phase III RELIEF study showed that TNX-102 SL demonstrated activity in addressing persistent pain, sleep disturbance, memory, fatigue and energy in patients treated with the medication.
“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. We believe the core symptoms of Long COVID, including fatigue, sleep disturbances, persistent pain and diffuse myalgia share an underlying pathogenesis with fibromyalgia,” Sullivan said in a statement.
In June, the U.S. Centers for Disease Control and Prevention (CDC) issued a new guidance for Long COVID.
