Tonix : Phase 3 Study On Posttraumatic Stress Disorder Fails To Meet Primary Endpoint
Tonix Pharmaceuticals Holding Corp. (TNXP) said that phase 3 RECOVERY Study of TNX-102 SL in posttraumatic stress disorder or PTSD 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 between TNX-102 SL and placebo. It is consistent with previously reported interim analysis.
“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 at Week 12,” said Seth Lederman, M.D., President and Chief Executive Officer.
Due to the complexity of PTSD as a syndrome and the demonstrated potential of TNX-102 SL to improve sleep quality in PTSD, the company said it plans to meet with the U.S. Food and Drug Administration to discuss a proposed new indication: TNX-102 SL for the treatment of sleep disturbance associated with PTSD.
The RECOVERY study was a double-blind, randomized, placebo-controlled, adaptive design study evaluating the efficacy and safety of TNX-102 SL 5.6 mg over 12 weeks of treatment for civilian and military-related posttraumatic stress disorder.
A pre-specified interim analysis was conducted by an unblinded Independent Data Monitoring Committee after half the target population was enrolled and evaluable in the first-quarter 2020.
The company announced it stopped enrollment in RECOVERY following a non-binding recommendation to stop the trial for futility by the IDMC.
The company chose to discontinue new enrollment but continue all currently enrolled participants at that time to completion. The IDMC decision to discontinue enrollment in the study was not related to safety of TNX-102 SL; the blinded safety data from the IA did not reveal any serious and unexpected adverse events.
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