Tonix Pharmaceuticals Doses First Patient in Phase 2 OASIS Study of TNX-102 SL for Acute Stress Reaction Reduction

Tonix Pharmaceuticals Holding Corp., a biotechnology company listed on Nasdaq under the symbol TNXP, has announced the initiation of an investigator-led Phase 2 clinical trial named OASIS. The trial aims to evaluate the effectiveness of TNX-102 SL, a sublingual tablet formulation, in mitigating the severity of acute stress reaction (ASR) and reducing the occurrence of acute stress disorder (ASD). The study is sponsored by the University of North Carolina (UNC) and is financially backed by a $3 million grant from the U.S. Department of Defense. Tonix Pharmaceuticals anticipates the release of the trial's topline results in the latter half of 2026.

The OASIS trial is designed to assess the safety and efficacy of TNX-102 SL in addressing adverse neuropsychiatric outcomes following trauma, focusing on patients who visit emergency departments (ED) after motor vehicle collisions. The study plans to recruit approximately 180 participants across various ED sites in the United States. These participants will be randomized to receive either TNX-102 SL 5.6 mg or a placebo for a two-week period.

Seth Lederman, M.D., the Chief Executive Officer of Tonix Pharmaceuticals, highlighted the significance of TNX-102 SL's impact on sleep quality in treating post-traumatic stress disorder (PTSD). He emphasized that addressing sleep disturbances is critical for managing ASR, as poor sleep can worsen other symptoms and impede recovery. Dr. Lederman noted the considerable unmet need for effective treatments for ASR following traumatic incidents, such as motor vehicle accidents or military experiences. He expressed optimism about the potential for TNX-102 SL, given previous data indicating improvements in PTSD symptoms during the initial weeks of treatment.

The OASIS trial is an extension of the knowledge and infrastructure gained through the AURORA initiative led by UNC. The AURORA project, supported by $40 million in funding, is a major national research effort aimed at enhancing the understanding, prevention, and recovery of individuals who experience traumatic events. It is backed by the National Institutes of Health (NIH), private foundations, and partnerships with organizations like Mindstrong Health and Verily Life Sciences, Alphabet's healthcare division.

Acute and chronic stress disorders impact both civilian and military populations. Statistics from the National Center for PTSD reveal that in the U.S., around 60% of men and 50% of women experience at least one trauma during their lifetime. Emergency departments see one-third of their visits involving trauma evaluations, accounting for 40-50 million patients annually. Among military personnel, a 2014 study found that 87% of 3,157 U.S. veterans reported exposure to at least one traumatic event during their service. Furthermore, approximately 500,000 U.S. troops who served between 2001 and 2015 were diagnosed with PTSD. Currently, no medication is available to address the immediate aftermath of traumatic events, aiming to prevent the development or worsening of ASD and ultimately thwarting PTSD.

TNX-102 SL is a centrally acting, non-opioid investigational drug formulated for chronic use, specifically designed for sublingual administration at bedtime to manage fibromyalgia. The tablet contains cyclobenzaprine hydrochloride, which interacts with multiple neuroreceptor subtypes believed to target non-restorative sleep, a characteristic of fibromyalgia. The formulation ensures efficient transmucosal absorption, with patents secured in various jurisdictions worldwide, offering market protection until 2034.

Tonix Pharmaceuticals, a fully integrated biotech firm, focuses on developing therapies for pain management and vaccines for public health issues. Its development portfolio targets central nervous system disorders, with an emphasis on advancing TNX-102 SL for managing fibromyalgia. The company also engages in the development of biologics for organ transplant rejection, autoimmune diseases, and infectious disease vaccines.