Tonix Pharmaceuticals (NASDAQ:TNXP) said it expects to receive the topline results from its 88-patient Phase 2 PREVENTION study of its investigational drug TNX-1900 for the prevention of migraine headaches in chronic migraineurs in early December 2023.
“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),” Tomix chief medical officer Dr. Gregory Sullivan said.
TNX-1900 is a proprietary formulation of oxytocin that contains magnesium which is being developed as a novel, non-CGRP antagonist approach to treatment for chronic migraineurs.
Tonix has shown in animal models that TNX-1900 potentiates the action of oxytocin at oxytocin receptors and potentially improves the consistency of treatment by reducing paradoxical high-dose inhibition.
It blocks the release of trigeminal neuropeptide calcitonin gene-related peptide (CGRP), a key peptide in the pathogenesis of migraine, from trigeminal ganglia neurons while limiting systemic exposure.
Tonix said that by engaging and activating oxytocin receptors in the trigeminal ganglia, the investigational drug has the potential to treat patients suffering from chronic migraines.
“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,” Tonix CEO Dr. Seth Lederman noted in a statement.
Tonix Pharmaceuticals (NASDAQ:TNXP) is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering.
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