Tonix Pharmaceuticals Holding (NASDAQ: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it has received approval from the U.S. Food and Drug Administration (“FDA”) for the Investigational New Drug (“IND”) application for the investigator-initiated OASIS trial. The OASIS trial is a Phase 2 trial to evaluate TNX-102 SL in reducing the severity of acute stress reaction (“ASR”) and the frequency of acute stress disorder (“ASD”) and posttraumatic stress disorder (“PTSD”). The trial will enroll approximately 180 acute trauma patients following motor vehicle collisions. It is sponsored by The University of North Carolina (“UNC”) Institute for Trauma Recovery and supported by a $3 million grant from the U.S. Department of Defense (“DoD”).
“No medication is currently available at or near the point-of-care to treat patients suffering from traumatic events and support long-term health,” commented Seth Lederman, M.D., CEO of Tonix. “There is an unmet need for treating ASR after traumatic events such as civilian motor vehicle collisions or warfighter experiences in forward bases or in theater. Previous trials of TNX-102 SL in PTSD suggested activity on sleep and stress related symptoms in the first several weeks of treatment.”
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About Tonix Pharmaceuticals Holding Corp.
Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system disorders. Tonix’s priority is to submit a New Drug Application (“NDA”) to the FDA for Tonmya, which has completed two positive Phase 3 studies for the management of fibromyalgia. Tonix intends to meet with the FDA in the first half of 2024 and submit an NDA for the approval of Tonmya for the management of fibromyalgia in the second half of 2024. TNX-102 SL is being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results from a proof-of-concept study were reported in the third quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2024. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome (“PWS”). TNX-2900 has been granted Orphan Drug designation by the FDA and an investigational new drug (“IND”) application has been cleared to support a Phase 2 study in PWS patients. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (“CD40L” or “CD154”) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-801 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. During the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (“NIH”), National Institute of Allergy and Infectious Diseases (“NIAID”) Project NexGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals. Tonix Medicines, the company’s commercial subsidiary, markets Zembrace(R) SymTouch(R) (sumatriptan injection) 3 mg and Tosymra(R) (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. For more information about Tonix, visit www.tonixpharma.com.
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