Phase III RECOVERY study of TNX 102 SL fails to meet significance in PTSD.- Tonix Pharma

Tonix Pharmaceuticals announced topline results from its Phase III RECOVERY study of TNX 102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the treatment of civilian and military-related posttraumatic stress disorder (PTSD). The RECOVERY study did not achieve statistical significance in the prespecified primary efficacy endpoint of change from baseline to Week 12 in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) between TNX 102 SL and placebo (p=0.343). In the primary analysis, TNX 102 SL subjects achieved a 20.7 unit reduction in CAPS-5 versus 18.5 units for placebo. TNX 102 SL separated from placebo in the first key secondary endpoint, Clinical Global Impression – Severity (CGI-S) scale (p=0.024) and in the Patient Global Impression of Change (PGIC), (p=0.007). TNX 102 SL also trended for improvement on the PROMIS Sleep Disturbance scale (p=0.055), consistent with the proposed mechanism of targeting the PTSD sleep disturbance. Among completers, there was a 58% observed mean reduction in symptoms in the active group compared to 49% in the placebo group, as measured by CAPS-5 total. TNX 102 SL is generally well tolerated and no new safety signals were observed.