Tonix Pharmaceuticals Initiates Phase 2 Clinical Study of TNX-201 in Episodic Tension-Type Headache

Tonix Pharmaceuticals Holding Corp. TNXP ("Tonix"), a clinical-stage company developing next-generation medicines for fibromyalgia, post-traumatic stress disorder, and episodic tension-type headache, today announced that it has begun randomizing patients into a Phase 2 clinical study of TNX-201 (dexisometheptene mucate) in episodic tension-type headache. The study is expected to enroll approximately 200 patients at nine clinical centers in the United States. Tonix plans to report top-line results from this study in the fourth quarter of 2015. This randomized, double-blind, placebo-controlled, proof-of-concept (POC) Phase 2 study will evaluate the efficacy and safety of a single 140 mg dose of TNX-201 versus placebo for the treatment of a single tension-type headache. In addition to the primary efficacy endpoint of pain-free at two hours post-dose as recommended by the U.S. Food and Drug Administration (FDA) for a prospective confirmatory tension headache study, this POC Phase 2 study will also assess efficacy according to a variety of measures, including: the proportion of patients reported to be pain-free at several other post-dose time intervals as assessed on a four-point Numeric Rating Scale (NRS), Visual Analog Scale (VAS), and binary questionnaire for self-reporting pain; the proportion of patients who utilize rescue medication during the 24-hour post-dose period; and the change from baseline pain severity at several time intervals. This study is adequately designed to establish efficacy and safety evidence to support a future confirmatory study. In addition, this POC Phase 2 study may reveal efficacy endpoints that are more relevant to episodic tension-type headache than pain-free at two hours. To learn more, please visit www.clinicaltrials.gov (NCT02423408). "Approximately 75 million people in the U.S. suffer from frequent episodic tension-type headache, a condition that is estimated to be three times as prevalent as migraine. We believe TNX-201 may offer differentiation from currently-approved drugs for episodic tension-type headache, all of which contain barbiturates," stated Seth Lederman, M.D., chairman and CEO of Tonix. "If approved by the FDA, TNX-201 may become the only non-narcotic prescription medicine for episodic tension-type headache and the first new prescription pharmaceutical approved for this indication in more than 40 years. We look forward to reporting top-line results from our Phase 2 study in episodic tension-type headache in the fourth quarter of this year." In a Phase 1 single ascending dose safety, tolerability, and pharmacokinetic study, TNX-201 was well-tolerated at all doses tested and no subject discontinued due to treatment-emergent adverse events. Dose-dependent pharmacokinetic behavior was observed, with no evidence of isomer interconversion.