A Phase 3 trial of Tonmya (cyclobenzaprine HCl sublingual tablets; Tonix Pharmaceuticals), an investigational treatment for military-related posttraumatic stress disorder (PTSD), will be stopped early after the Independent Monitoring Committee (IDMC) found inadequate separation from placebo at week 12.
Tonix made the announcement after the IDMC reviewed results of the first 274 participants (50%) that were randomized in the HONOR trial. The recommendation to stop the trial was based on a pre-specified study continuation threshold at week 12.
Participants in the trial were randomized to receive Tonmya 5.6mg sublingually at bedtime for 12 weeks or placebo sublingual tablets. The treatment group did show separation from placebo on the Clinician-Administered PTSD Scale for DSM-5 (CAP-5) (primary endpoint; P=.019) and the Clinical Global Impression – Improvement (CGI-I) scale (secondary endpoint; P=.015) at week 4 but demonstrated inadequate separation from placebo at week 12.
“We are encouraged by the meaningful clinical improvement at week 4, which replicates findings in the previously-reported Phase 2 AtEase Study,” said Seth Lederman, MD, President and Chief Executive Officer of Tonix. “We believe the results from the HONOR study will help to design the next pivotal study.”
The Company reaffirmed their commitment to seeking treatments for PTSD and stated that they plan on advancing the development of TNX-601 (tianeptine oxalate) for treatment of PTSD with daytime dosing.
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