By Alex Keown
Shares of Tonix Pharmaceuticals shot up 25 percent in premarket trading this morning after the company announced there may be a future for its late-stage posttraumatic stress disorder treatment Tonmya after a Phase III trial was halted early in July following a data review showed an inadequate response.
After the trial was halted, the company examined some data and noted that a “retrospective analysis” showed a treatment effect in participants who experienced trauma less than or equal to nine years prior to screening, which was approximately 50 percent of the modified intent-to-treat population. Tonix noted that the impact of “time since trauma” on Tonmya treatment response was not evident in the P201 Phase II trial. The company said that might relate to the fact that the trial had “relatively fewer participants who experienced trauma greater than nine years before screening.”
Tonix Chief Executive Officer Seth Lederman said future studies of Tonmya will focus on patients with more recent trauma of fewer than nine years.
“The finding that treatment response to Tonmya in P301 decreases as the time since trauma gets longer, suggests that military service members and veterans with PTSD are transitioning from a Tonmya-treatment responsive state to a non-responsive state after approximately nine years. These results emphasize the urgency for early diagnosis and treatment for PTSD, especially for military-related PTSD,” Lederman said in a statement.
PTSD affects approximately 11 million U.S. adults and is characterized by chronic disability, inadequate treatment options, especially for military-related PTSD, and an overall high utilization of health care services that contributes to significant economic burdens. TNX-102 SL (cyclobenzaprine HCl sublingual tablets), which would be marketed under the name Tonmya, is derived from the muscle relaxant Cyclobenzaprine.
In July Tonix halted its P301 HONOR trial early following an analysis of 12-week data from an Independent Data Monitoring Committee. The IDMC reported that at the 12-week mark, there was “inadequate separation” between patients with PTSD symptoms who were treated with Tonmya and placebo. However, the company said in July that at week four of the study, “meaningful improvement in overall PTSD symptoms was observed.”
Tonix said will present a poster on the Tonmya at the 2018 Military Health System Research Symposium (MHSRS) in Kissimmee, Fla. that includes the new findings.
Gregory Sullivan, Tonix chief medical officer, said PTSD is a complex condition. Although it is caused by trauma, there is clear evidence of a “dynamic pathophysiology which changes over time.”
“Treatment responsiveness over the course of the disease may vary with different pharmacological classes, and may also differ between PTSD from combat versus other types of trauma. Yet it is unclear what specific features of PTSD change over time and make it less treatment responsive. These findings of P301 and P201 show that in PTSD, time since trauma is important in the treatment response to Tonmya,” Sullivan said in a statement.
Tonix said there were no serious or unexpected adverse events in either the Phase II or Phase III trials. The adverse events in both studies were comparable and consistent with the company’s experience in prior fibromyalgia studies, Tonix said.