Tonix stops Phase III of PTSD candidate on lack of separation from placebo

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) said it will stop the Phase III HONOR trial of Tonmya (Sublingual TNX-102) to treat military-related post-traumatic stress disorder (PTSD) after the candidate showed "inadequate separation" from placebo at an interim analysis of the primary endpoint at week 12.

The primary endpoint evaluated the change from baseline in the severity of PTSD symptoms at week 12 as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). An IDMC conducted a prespecified interim analysis of the double-blind, U.S. trial after half of the patients (n=274) completed the 12-week course of treatment comprising placebo or two 2.8 mg tablets of Tonmya given each day at bedtime...