Tonix Pharmaceuticals to discontinue Phase 3 HONOR study of PTSD med

Tonix Pharmaceuticals announced that it will stop the Phase 3 HONOR study of Tonmya in military-related posttraumatic stress disorder due to inadequate separation from placebo on the primary endpoint at week 12. The primary analysis was the change from baseline in the severity of PTSD symptoms as measured by the Clinician-Administered PTSD Scale for DSM-5 between those treated with Tonmya and those receiving placebo, after 12 weeks of treatment. The Independent Data Monitoring Committee reviewed the results of the first 50 percent of participants randomized in the HONOR study and recommended stopping the trial based on a pre-specified study continuation threshold at week 12. However, meaningful improvement in overall PTSD symptoms was observed at week 4. At week 4, the Tonmya treated group separated from placebo in CAPS-5 and in the Clinical Global Impression – Improvement scale, a key secondary endpoint. Also, at week 4, sleep quality improved as measured by both the PROMIS sleep disturbance scale and the CAPS-5 sleep disturbance item, supporting the proposed mechanism of action of Tonmya. Preliminary safety data from these participants did not reveal any serious and/or unexpected adverse events and the decision to discontinue the study is not related to safety.
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