Results

Shrink the patient group, boost the efficacy: Tonix says a retro look shows promise in select PTSD group

A backwards glance at trial data — and a reshuffling of the patients involved — has reverted failure to optimism for Tonix Pharmaceuticals. At least that’s what company execs are rooting for, according to an update they’ve provided today on its PTSD drug Tonmya.

You might remember Tonmya for the recent Phase III trial flop that washed Tonix’s stock into the gutter, sinking the share price nearly 70% over the past four weeks.

The company’s drug is an under-the-tongue formulation of cyclobenzaprine, commonly used as a muscle relaxer. The drug apparently failed to improve PTSD symptoms when compared to placebo, missing its primary endpoint after 12 weeks of treatment.

But now, the NYC-based company says it’s taken a deeper look at the data on that trial — along with some old data from a Phase II study — and has determined a subset of the patients saw better results than others. Tonix shrunk the patient group to only include those with PTSD who had suffered their trauma within the past 9 years. These patients — which make up about 50% of the total patient group — saw a significantly better response, with a P value of 0.039.

Seth Lederman

“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,” said the company’s CEO Seth Lederman in a statement. “These results emphasize the urgency for early diagnosis and treatment for PTSD, especially for military-related PTSD.”

Unfortunately for Tonix, it doesn’t look like investors are quite as jazzed about the retrospective analysis. The stock $TNXP is up about 4% from yesterday’s close as of press time, but that’s still down about 68% from its pre-trial-results crash last month.

Tonmya, also known as TNX-102 SL, had received breakthrough therapy designation from the FDA for its applications in PTSD. And just last month, the agency also handed over fast track status for the drug in a different indication: agitation in Alzheimer’s.

The company says its future clinical trials in PTSD will only look at patients who experienced trauma within the past 9 years.


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