Tonix Pharmaceuticals (TNXP.Q) announced today that it has received the official minutes from a Type B pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-102 SL (cyclobenzaprine HCI sublingual tablets) as a potential treatment for Long COVID Syndrome.
“TNX-102 SL is in mid-Phase 3 development for the treatment of fibromyalgia. The proposed mechanism of TNX-102 SL is to improve sleep quality…we plan to conduct clinical trials to determine whether TNX-102 SL improves sleep in certain of these other disorders in addition to Long COVID and fibromyalgia,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix.
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human diseases and alleviate suffering. With this in mind, the Company’s TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride. Aside from sounding like a spell from Harry Potter, cyclobenzaprine hydrochloride is used as a central nervous system (CNS) muscle relaxant designed to relieve pain and discomfort. Utilizing cyclobenzaprine hydrochloride, TNX-102 SL is intended to be used as a daily bedtime treatment for fibromyalgia, a disorder characterized by widespread pain, fatigue, sleep problems and mental distress. In addition to fibromyalgia, TNX-102 SL is also in clinical development for PTSD, alcohol use disorder and agitation in Alzheimer’s disease.
I thought this article was about COVID Long Syndrome. Why are we talking about fibromyalgia? Well, Long COVID is a protracted Syndrome experienced by many people following SARS-CoV-2 infection that is defined by a number of persistent symptoms including widespread pain, fatigue, sleep problems, brain fog, and difficulty focusing, to name just a few. By now, you’ve probably put two and two together and realized that almost all of the symptoms associated with fibromyalgia overlap with the symptoms of Long COVID. With this in mind, Tonix believes the minutes from its Type B meeting with the FDA will provide a path to agreement on the design of a Phase 2 study. The Company’s planned Phase 2 study will focus on Long COVID patients whose primary symptoms overlap with fibromyalgia, leveraging what Tonix has learned about TNX-102 SL from its participants enrolled in various fibromyalgia trials to date.
“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,” commented Gregory Sullivan, M.D., Chief Medical Officer of Tonix.
According to Tonix’s Q2 2021 Financial Results, the Company was able to increase its cash position substantially from $77.1 million on December 31, 2020, to $165.7 million as of June 30, 2021. During the same period, Tonix’s total assets increased to $189,493,000 and its total liabilities decreased to $8,672,000. Keep in mind, the Company’s cash used in operations was roughly $19.1 million in Q2 2021 compared to $10.1 million year-over-year. This increase is largely due to increased expenses related to Tonix R&D programs. Looking forward, Tonix is planning to submit an IND application in Q4 2021 to support a Phase 2 study for the management of a subset of Long COVID patients whose symptoms overlap with fibromyalgia.
Tonix’s share price opened at $0.767, up from a previous close of $0.689. The Company’s shares are up 4.87% and were trading at $0.723 as of 10:37AM ET.