Benzinga | Dec 21, 2020 07:16AM EST

Tonix Pharmaceuticals Reports Results from Phase 3 RECOVERY Study of TNX-102 SL in PTSD Did Not Achieve Statistical Significance In The Prespecified Primary Efficacy Endpoint

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