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Tonix Pharmaceuticals Reports Topline Results from Phase 3 RECOVERY Study of TNX-102 SL in PTSD and Outlines Future Development Plans
Primary Endpoint For Full Cohort of Enrolled Participants Did Not Achieve Statistical Significance (P=0.343), Consistent with Previously Reported Interim
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Primary Endpoint For Full Cohort of Enrolled Participants Did Not Achieve Statistical Significance (P=0.343), Consistent with Previously Reported Interim Analysis Encouraging Activity of TNX-102 SL Observed in Secondary Endpoints: Clinical Global Impression – Severity (P=0.024), Patient Global Impression of Change (P=0.007) and PROMIS Sleep Disturbance (P=0.055) Participants were 94% Civilian PTSD and 79% Female: Global Impression and Sleep Results Similar to Prior Studies of TNX-102 SL in Predominantly Male, Military-Related PTSD Studies TNX-102 SL Generally Well Tolerated; No New Safety Signals Observed: No Change in Weight or Blood Pressure Total CAPS-5 Decreased by 58% in Treatment Group and 49% in Placebo Group Planning Development of TNX-102 SL for Treatment of PTSD Sleep Disturbance Indication, Pending FDA Discussion CHATHAM, N.J., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced topline results from its Phase 3 RECOVERY study1 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) (Table 1). 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) (Table 1) 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 (Table 1). 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. “As expected from the futility result at the interim analysis in the first quarter of 2020, TNX-102 SL did not separate on the primary endpoint of CAPS-5 a...