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Tonix Pharmaceuticals Completes Clinical Stage of Phase 2 PREVENTION Study of TNX-1900 for the Prevention of Migraine Headaches in Chronic Migraineurs
Topline results expected early December 2023 Novel formulation of intranasal oxytocin contains magnesium (Mg2+), shown to potentiate the analgesic effects of
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Topline results expected early December 2023 Novel formulation of intranasal oxytocin contains magnesium (Mg2+), shown to potentiate the analgesic effects of oxytocin on the oxytocin receptor in animal models TNX-1900 blocks release of CGRP, a key peptide in the pathogenesis of migraine, from trigeminal ganglia neurons while limiting systemic exposure CHATHAM, N.J., Oct. 26, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the completion of the clinical phase of the Phase 2 proof-of-concept, double-blind, randomized, placebo-controlled PREVENTION1 study of TNX-19002 (intranasal potentiated oxytocin) as a potential treatment for the prevention of migraine headaches in chronic migraineurs. A total of 88 patients were enrolled in this multi-site study in the U.S. Topline results are expected in early December 2023. TNX-1900 is a proprietary formulation of oxytocin that contains magnesium, which Tonix has shown in animal models potentiates the action of oxytocin at oxytocin receptors and potentially improves the consistency of treatment by reducing paradoxical high-dose inhibition. Its unique, multimodal mechanism of action includes an ability to inhibit the release of the trigeminal neuropeptide calcitonin gene-related peptide (CGRP) in blood vessels within the brain, its lining and the brainstem, and to suppress signaling in pain neurons. Tonix believes that by engaging and activating oxytocin receptors in the trigeminal ganglia, TNX-1900 has the potential to help those suffering from chronic migraine. “TNX-1900 is being developed as a novel, non-CGRP antagonist approach to treatment for chronic migraineurs,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “There are an estimated four million individuals in the U.S. suffering from this debilitating condition, and despite several classes of migraine preventives available, there remains an unmet need for novel approaches.” “With the last patient now treated, we look forward to analysis of the results of this proof-of-concept study, which will help to inform our plans as we discuss next steps with the U.S. Food and Drug Administration (FDA),” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “We...