Tonix Pharmaceuticals Announces Top Line Results From Phase 2 Proof-of-Concept Clinical Study

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) announced top line results of the Phase 2 proof-of-concept (POC) clinical study of TNX-201 (dexisometheptene mucate) in episodic tension-type headache (ETTH).
According to the news:

Based on preliminary analysis of the results from this exploratory study, Tonix has determined that the study did not achieve its primary efficacy endpoint of participants achieving headache pain-free status at two hours after dosing.  The study also did not achieve two other primary endpoints, which were the proportion of participants with at least a 70% reduction in pain from baseline on the Visual Analog Scale (VAS) at two hours after dosing, and an increase of the mean change from baseline to two hours post-dose in the VAS score. The goal of this POC trial was to evaluate the potential clinical benefit of using TNX-201 to treat tension-type headache.  A single 140 mg dose of TNX-201 was compared to placebo for the treatment of a single tension-type headache.  A single 140 mg dose of TNX-201 proved to be safe and extremely well tolerated by all participants with ETTH. No serious adverse events were reported throughout the duration of the study. There were no treatment emergent adverse event categories reported by more than one participant (1.4%) in either treatment group during the double-blinded treatment period.

Seth Lederman, M.D., Tonix’s president and CEO commented:

We were interested in exploring the potential clinical benefit of TNX-201 as a new class of analgesic that might offer a non-addictive headache treatment option. Racemic isometheptene mucate previously had been used as a treatment for both tension-type headaches and migraine. Given the current treatment landscape, we determined tension-type headache to be the most probable and feasible path to commercialization for TNX-201. We executed a well-designed and efficient POC study to determine whether our hypothesis had merit.  Among other things, the data showed that TNX-201 did not demonstrate efficacy in patients with ETTH whether or not they had a history of migraine headaches.  Although TNX-201 has proved to be safe and very well tolerated in the study, our review of the results supports discontinuing all work on this program.

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