Tonix Pharmaceuticals announces FDA IND clearance for trial of TNX-102 SL

Tonix Pharmaceuticals announced the U.S. Food and Drug Administration, FDA, has cleared the Investigational New Drug, IND, application for the Phase 2 investigator-initiated OASIS trial to evaluate TNX-102 SL1 in reducing the severity of acute stress reaction and the frequency of acute stress disorder and posttraumatic stress disorder. The trial is sponsored by The University of North Carolina Institute for Trauma Recovery and supported by a $3 million grant from the U.S. Department of Defense. “No medication is currently available at or near the point-of-care to treat patients suffering from traumatic events and support long-term health,” said Seth Lederman, M.D., Chief Executive Officer 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.2,3 The study is motivated by the observation that the symptoms of ASR and PTSD are similar and by the hypothesis that TNX-102 SL’s effect on sleep quality may reduce ASR symptoms.”