Tonix study analysis shows 'meaningful' response to Tonmya in PTSD participants
Tonix Pharmaceuticals presented a poster at CNS Summit 2018 held November 1-4, 2018, in Boca Raton, Fla. A poster, entitled "Time Since Trauma in PTSD: Phase 3 Multi-Center, Double-Blind, Placebo-Controlled Trial of TNX-102 SL, a Sublingual Formulation of Cyclobenzaprine, in Military-Related PTSD" includes results and retrospective analyses from the Phase 3 P301 study. TNX-102 SL, or Tonmya, is being developed for the treatment of posttraumatic stress disorder (PTSD). The poster can be found on the Scientific Presentations page of Tonix's website. The poster presentation reports that a retrospective analysis revealed a treatment effect in participants who experienced trauma less than or equal to nine years prior to screening. For this subgroup, the p-value of the primary endpoint at Week 12, using mixed model repeated measures with multiple imputation, was 0.039. In contrast, there was no benefit relative to placebo in the participants who experienced trauma more than nine years prior to screening. A retrospective analysis of female participants overall, and of military participants with non-combat index traumas experienced less than or equal to nine years from screening, suggests clinically meaningful separation from placebo at Weeks 4 and 12 in these specific subgroups. The female subgroup experienced an 11.5 point improvement in CAPS-5 at Week 4 and 9.1 point improvement at Week 12, while the non-combat participant subgroup experienced a 4.8 point improvement at Week 4 and 4.4 point improvement at Week 12. In addition, the Week 4 assessment of CAPS-5 in the Phase 3 HONOR study showed clinically meaningful improvement at this time point in the entire modified intent-to-treat population. Furthermore, for study participants who experienced trauma less than or equal to nine years prior to screening, all five secondary measures showed a p-value of less than0.05 at the Week 12 endpoint, indicating possible global and functional recovery, and improved sleep quality and mood after 12 weeks of Tonmya treatment compared with placebo. Based on these findings and following a recent Breakthrough Therapy Type B Clinical Guidance meeting with the U.S. FDA, the company plans to incorporate several new design features into the new Phase 3 study, including restricting enrollment of study participants to individuals with PTSD who experienced an index trauma within nine years of screening; enrolling participants who have experienced civilian traumas, in addition to those with military-related traumas; and a CAPS-5 primary endpoint assessed at Week 4 instead of at Week 12.