Tonix Pharmaceuticals presented clinical data on acute stress reaction and prevention of PTSD data of TNX-102 SL in two poster presentations and presented preclinical data demonstrating automated high-throughput assay enabling screening for therapeutics to accelerate wound healing in a third poster presentation at the 2024 Military Health System Research Symposium, MHSRS, held August 26-29, 2024, in Kissimmee, Fla. TNX-102 SL is being evaluated for the reduction in severity of acute stress reaction and the frequency of acute stress disorder and posttraumatic stress disorder when administered within 24 hours of trauma event. In two double-blind, randomized clinical trials of military-related PTSD, TNX-102 SL showed effects on sleep and PTSD symptoms in two and four weeks of treatment. Supportive data on the effects of TNX-102 SL on reducing PTSD symptoms suggest early intervention immediately after trauma using TNX-102 SL has the potential to reduce ASR/ASD symptoms which are similar to those of PTSD. TNX-102 SL has been well-tolerated with no recognized liability for tolerance or abuse. Data from these trials support testing of TNX-102 SL within 24 hours of index trauma for effects on acute stress reaction symptoms and the incidence of PTSD. In the U.S. Department of Defense-funded Optimizing Acute Stress Reaction Interventions trial conducted by the University of North Carolina under an investigator-initiated investigational new drug application, 14 days of bedtime TNX-102 SL will be dosed and tested in the immediate aftermath of motor vehicle collision. The study will test the potential for TNX-102 SL to target trauma-related sleep disturbance and its ability to facilitate recovery from ASR and to prevent PTSD.
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