Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a company that is developing innovative pharmaceutical products to address public health challenges, presented entitled “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) at the 72nd Annual Scientific Convention of the Society of Biological Psychiatry in San Diego. The poster can be found on the Scientific Presentations page on Tonix’s website. A moderator is a characteristic of study participants that is associated with a treatment response.
Baseline posttraumatic stress disorder (PTSD) severity threshold and combat trauma-related PTSD were two potential moderators of treatment response that were further examined. A retrospective analysis of the Phase 2 AtEase* data indicated a study entry Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) severity score of ≥33 is more aligned with the entry criteria of previous PTSD pharmacotherapy registration trials using prior CAPS versions. In the AtEase CAPS-5 ≥33 subset, the effect size of TNX-102 SL** 5.6 mg is approximately 0.5 on total CAPS-5 and also approximately 0.5 on cluster B (intrusion) and cluster E (arousal and reactivity) scores. Another potential moderator of treatment response was combat trauma, and the subgroup of AtEase with PTSD from combat-type traumas had statistically significant effects of TNX-102 SL 5.6 on CAPS-5 total severity and cluster B and cluster E, and on overall functional improvement by Sheehan Disability Scale total score, work and social items. TNX-102 SL was well-tolerated with a high completion rate in AtEase. There were no adverse event-related discontinuations; non-dose related tongue numbness was common, generally transient, and never rated as severe. No clinically significant changes in weight or vital signs over the 12 weeks of study were observed.
Seth Lederman, M.D., president and chief executive officer of Tonix, commented, “We continue to work with the U.S. Food and Drug Administration (FDA) to accelerate the development and registration of TNX-102 SL for PTSD. Our Phase 3 HONOR study is currently enrolling participants with military-related PTSD. A planned unblinded interim analysis on approximately 50% of the randomized participants (N=275) is on track for the first half of 2018.”
At Ease is a Phase 2 multicenter, 12-week, double-blind placebo-controlled study conducted at 24 U.S. sites in men and women ages 18-65 years. Inclusions: PTSD DSM-5 Criterion A trauma(s) incurred during military service since 2001; screening and baseline CAPS-5 score ≥29; free of antidepressants ≥2 months from baseline; free of or washed off from other psychotropics; not participating in trauma-focused psychotherapy within a month from baseline. Exclusions: serious suicide risk; substance/alcohol use disorders within 6 months; lifetime bipolar I or II, psychotic, obsessive-compulsive, or antisocial personality disorders. Participants were randomized in 2:2:1 ratio to placebo, TNX-102 SL 2.8 mg or TNX-102 SL 5.6 mg. Primary analysis: comparison of mean change from baseline at Week 12 in CAPS-5 score between TNX-102 SL 2.8 mg and placebo.
