After scoring two promising FDA designations on its lead drug, tiny Tonix Pharmaceuticals is aborting its late-stage study in PTSD due to lousy results — nearly flat-lining the company’s stock Friday morning.
The drug, called Tonmya, apparently failed to improve PTSD symptoms when compared to placebo, missing its primary endpoint after 12 weeks of treatment. Tonmya is an under-the-tongue formulation of cyclobenzaprine, commonly used as a muscle relaxer.
Shares of Tonix $TNXP were halted in pre-market trading. But once Nasdaq hit the play button, Tonix tanked over 77%.
Although the Phase III trial crashed and burned, the company still has hopes for a reconfigured pivotal study, pointing to data at 4 weeks that showed some early promise.
“At week 4, the Tonmya treated group separated from placebo in CAPS-5 (p = 0.019) and in the Clinical Global Impression – Improvement (CGI-I) scale (p = 0.015), a key secondary endpoint,” the company said in a statement. “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.”
Now, it looks like Tonix will try to redesign its trial with new goalposts. The company’s president and CEO Seth Lederman said they were “encouraged by clinical improvement at week 4,” and will use data from this failed study to design the next pivotal study.
“We plan to meet with the FDA as soon as possible to discuss the HONOR results and our proposal to conduct the primary analysis at the week-4 time point in the next pivotal study,” Lederman said.
He also blamed the company’s failure on the difficulties of their chosen indication. “These results underscore the challenges in designing and conducting well-controlled clinical studies in PTSD, especially military-related PTSD,” he said.
Tonmya, also known as TNX-102 SL, had received breakthrough therapy designation from the FDA for its applications in PTSD. And just this month, the agency also handed over fast track status for the drug in a different indication: agitation in Alzheimer’s.
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