Tonix Pharma Presented Data on TNX-102 SL for Stress, PTSD, and Wound Healing at 2024 MHSRS

Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company, has announced significant developments in its efforts to combat acute stress reactions (ASR) and posttraumatic stress disorder (PTSD). At the 2024 Military Health System Research Symposium (MHSRS) in Kissimmee, Florida, Tonix presented clinical data and preclinical findings related to their product TNX-102 SL. This sublingual tablet is being investigated for its potential to alleviate symptoms of ASR and reduce the occurrence of acute stress disorder (ASD) and PTSD when administered shortly after a traumatic event.

TNX-102 SL has undergone two double-blind, randomized clinical trials focused on military-related PTSD. These studies revealed that the medication can positively affect sleep and overall PTSD symptoms within just a few weeks of treatment. The data suggest that early intervention with TNX-102 SL immediately post-trauma could mitigate symptoms of ASR and ASD, which are closely related to those of PTSD. Importantly, TNX-102 SL has shown a good tolerance profile with no significant risk of abuse.

Building on this promising data, an investigator-initiated Phase 2 trial, funded by the U.S. Department of Defense, is set to begin in the third quarter of 2024. Conducted by the University of North Carolina, the Optimizing Acute Stress Reaction Interventions (OASIS) trial will investigate the effectiveness of TNX-102 SL in reducing posttraumatic neuropsychiatric issues among emergency department patients who have experienced a motor vehicle collision. The trial will enroll approximately 180 participants, who will be randomly assigned to receive either TNX-102 SL or a placebo for two weeks, starting within 24 hours of the traumatic event.

Tonix Pharmaceuticals' CEO, Dr. Seth Lederman, emphasized the importance of addressing sleep disturbances, which play a crucial role in the development and persistence of PTSD. By improving sleep quality in the initial aftermath of trauma, TNX-102 SL has the potential to alter the progression of posttraumatic pathology, facilitating early recovery. The OASIS study aims to verify whether TNX-102 SL can reduce ASR symptoms, offering a new treatment option that could enhance recovery, job performance, and the quality of life for military personnel, veterans, and civilians alike.

Tonix also highlighted its third poster presentation at the MHSRS, showcasing preclinical data on a new high-throughput assay designed to improve wound healing. This innovative method combines automated miniaturized scratch assays with cell-painting techniques, allowing for the extensive screening of potential wound-healing therapies and identifying their mechanisms of action.

Additionally, Tonix is advancing its CNS portfolio, which includes TNX-1300 for cocaine intoxication and TNX-1500 for organ transplant rejection and autoimmune diseases. The company is also preparing to submit a New Drug Application (NDA) for TNX-102 SL for the management of fibromyalgia, a move anticipated in the second half of 2024. This submission follows two successful Phase 3 studies and an FDA Fast Track designation for the drug.

Tonix’s efforts extend beyond CNS disorders. The company is engaged in developing TNX-4200, a broad-spectrum antiviral agent targeting CD45, under a $34 million contract with the Defense Threat Reduction Agency. This initiative underscores Tonix’s commitment to enhancing medical readiness in the face of biological threats.

These developments underscore Tonix Pharmaceuticals' dedication to addressing both immediate and long-term health challenges faced by those exposed to traumatic events, offering hope for improved interventions and outcomes for affected individuals.

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