Tonix Pharmaceuticals has commenced a critical Phase 2 clinical trial targeting acute stress reaction (ASR), a significant milestone in addressing psychological trauma among civilians and military personnel. The OASIS trial, sponsored by the University of North Carolina's Institute for Trauma Recovery and supported by a $3 million U.S. Department of Defense grant, will investigate TNX-102 SL's potential to mitigate early stress symptoms.
The study will enroll approximately 180 motor vehicle trauma survivors across emergency departments nationwide, focusing on evaluating the medication's effectiveness in reducing ASR severity and preventing the onset of acute stress disorder (ASD). Previous research has indicated that TNX-102 SL demonstrates improvements in sleep patterns and early post-traumatic stress symptoms, which are considered crucial factors in managing psychological trauma.
Dr. Seth Lederman, Tonix's CEO, emphasized the urgent need for interventions that can effectively address traumatic event consequences. The trial represents a significant step toward developing targeted treatments for individuals experiencing immediate psychological distress following traumatic incidents.
The research holds substantial implications for both civilian and military populations, where acute stress reactions can significantly impact individual and collective mental health. By potentially interrupting the progression from acute stress reaction to more chronic conditions like post-traumatic stress disorder, the trial could offer a critical early intervention strategy.
Topline data from the OASIS trial is anticipated in the second half of 2026, with researchers and medical professionals closely monitoring the potential breakthrough in trauma response treatment. The study builds upon Tonix's ongoing commitment to developing innovative solutions for central nervous system disorders and addressing complex public health challenges.
