Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), which is developing a next-generation treatment for posttraumatic stress disorder (PTSD), will announce new results today from a retrospective analysis of the data from the AtEase study, a 12-week, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating TNX-102 SL*, 5.6 mg, in military-related PTSD.
The retrospective analysis focused on patients whose total CAPS-5 entry score was greater than or equal to 33. The analysis revealed that at the 5.6 mg dose, TNX-102 SL had a significant improvement (p=0.012) in reckless or self-destructive behavior, which can include dangerous driving, high-risk thrill-seeking, excessive alcohol or drug use, injurious behaviors to self or others, or suicidal behaviors.
Gregory Sullivan, M.D., chief medical officer of Tonix, will present these findings at the International Society for Traumatic Stress Studies 32nd Annual Meeting today, November 10, 2016, in Dallas, Texas in a poster session. The poster showcasing this new data can be found on Tonix’s website on the Scientific Presentations page.
Dr. Sullivan commented, “Not only did the retrospective analysis support the viability of TNX-102 SL, 5.6 mg, as a potential treatment for military-related PTSD, it also demonstrated that Tonix’s lead compound could potentially fulfill a critical need in the military and veteran populations with PTSD who have elevated rates of suicidal behaviors, as well as vehicular and other accidents resulting from high-risk behaviors.” Dr. Sullivan continued, “The most common side effect in AtEase was transient tongue numbness at the site of administration in about 38% of those on TNX-102 SL. Systemic side effects that were elevated over those seen with placebo were somnolence, headache, and sedation at rates of 12-16% in the TNX-102 SL, 5.6 mg, group.”
Seth Lederman, M.D., president and chief executive officer of Tonix, added, “These findings further validate our focus on PTSD and our commitment to the patients who await a new therapeutic option. The anticipated commencement of the Phase 3 HONOR study in the first quarter of 2017 provides an opportunity for patients with military-related PTSD to take part in a milestone study.”
*TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an Investigational New Drug and has not been approved for any indication.
About Tonix Pharmaceuticals Holding Corp.
Tonix is developing next-generation medicines for common disorders of the central nervous system, with its lead program focusing on posttraumatic stress disorder. This disorder is a serious condition characterized by chronic disability, inadequate treatment options, high utilization of healthcare services, and significant economic burden. This press release and further information about Tonix can be found at www.tonixpharma.com.