|Title:||Phase 2 Multisite Double-Blind Placebo-Controlled Trial of TNX-102 SL in Military-Related Posttraumatic Stress Disorder: Mediators and Moderators of Treatment Response (Poster No. 3001130)|
|Date:||Saturday, May 20, 2017|
|Time:||5-7 p.m. PDT|
|Location:||Sapphire CP, Hilton San Diego Bayfront|
NEW YORK, May 11, 2017 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a company that is developing innovative pharmaceutical products to address public health challenges, announced it will present additional analyses of data from its Phase 2 study in military-related posttraumatic stress disorder, or PTSD, at the 72 nd Annual Scientific Convention of the Society of Biological Psychiatry (SOBP) on May 20, 2017 in San Diego. Gregory Sullivan, M.D., chief medical officer of Tonix, will present moderators and mediators analyses from Tonix's Phase 2 AtEase study of TNX-102 SL *. TNX-102 SL is the first PTSD drug candidate designated by the U.S. Food and Drug Administration (FDA) as a Breakthrough Therapy. A moderator is a characteristic of participants going into the study that is associated with a response to treatment, while a mediator is a clinical finding that the response to therapy may depend on, such as sleep quality. Details of the poster presentation follow.
*TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication. About TNX-102 SL and the Phase 3 HONOR Study TNX-102 SL is a patented** sublingual formulation of low dose cyclobenzaprine that is in Phase 3 development for PTSD. In a Phase 2 study, TNX-102 SL 5.6 mg was found to be effective in treating military-related PTSD, and FDA has awarded TNX-102 SL Breakthrough Therapy designation. Tonix is currently conducting a Phase 3 HONOR study of TNX-102 SL in military-related PTSD in the United States. HONOR is a 12-week randomized, double-blind, placebo-controlled trial evaluating the efficacy of TNX-102 SL 5.6 mg in participants with military-related PTSD. This two-arm, adaptive-design trial is targeting to enroll up to approximately 550 participants across approximately 35 clinical sites. An unblinded interim analysis will be conducted once the study has accumulated efficacy results from approximately 275 randomized participants. In a recent Cross-disciplinary Breakthrough meeting, FDA confirmed that a single-study NDA approval could be possible if the topline data from HONOR is statistically very persuasive. Additional details of HONOR are available at www.thehonorstudy.com or https://clinicaltrials.gov/ct2/show/NCT03062540. ** The U.S. Patent and Trademark Office has issued a patent (U.S. Patent No. 9,636,408) protecting the composition and manufacture of the unique formulation that characterizes TNX-102 SL. This patent is expected to provide Tonix with U.S. market exclusivity until 2034 upon NDA approval.