Tonix Pharmaceuticals says USAMMDA exercising right to terminate CRADA
Tonix Pharmaceuticals announced that on April 18 the company received a notice of termination, effective April 29, whereby the U.S. Army Medical Materiel Development Activity, or USAMMDA, is exercising its contractual right to terminate without cause the Collaborative Research and Development Agreement, or CRADA, entered into on December 4, 2015 between the company and USAMMDA relating to the development of Tonmya or TNX-102 SL for the treatment of Posttraumatic Stress Disorder. "The termination does not affect Tonix's finances or the conduct of the ongoing RECOVERY trial in PTSD. Due to the statutory limitations on all CRADAs, Tonix's agreement with USAMMDA never contemplated nor contained any provision for funding Tonix or any PTSD study. There is, therefore, no financial impact to Tonix as a result of this action. A key objective of the CRADA was for USAMMDA to assist Tonix in recruiting active duty personnel from military treatment facilities into the Phase 2 AtEase and Phase 3 HONOR studies of military-related PTSD. However, no patients were recruited by USAMMDA from MTFs into either study. The ongoing RECOVERY trial is recruiting only patients whose PTSD results from trauma that occurred less than nine years before screening. Since the large U.S. troop deployments into the war zones in Iraq and Afghanistan were more than nine years ago, the number of relevant potential trial participants in MTFs would be lower than during our previous clinical trials. Therefore, we believe there is no patient recruitment impact to Tonix as a result of this action. Although a potential benefit of the CRADA was cooperation in planning PTSD studies, USAMMDA was not involved in the planning or execution of any Tonix PTSD study. Therefore, we believe there is no research or development impact to Tonix as a result of this action," the company said.