Tonix Pharmaceuticals has announced the initiation of the Phase 2 PREVENTION study of the company’s TNX-1900 intranasal potentiated oxytocin for the prevention of migraine headaches. Tonix licensed TNX-1900 for the treatment of migraine from Trigemina in June 2020, and the company announced in November 2021 that the FDA had cleared an IND for a Phase 2 trial of the nasal spray for migraine.
The PREVENTION study is expected to enroll 300 patients with chronic migraines who will get either twice daily TNX-1900, once daily TNX-1900 plus once-daily placebo nasal spray, or twice daily placebo. The company said that it anticipates releasing interim results by the end of this year.
Tonix CEO Seth Lederman said, “Despite several classes of migraine preventatives available, there remains an unmet need for novel approaches with an estimated four million individuals in the United States suffering from chronic migraine, often a seriously disabling condition. TNX-1900 has a unique, multimodal mechanism of action, that includes an ability to inhibit the release of the trigeminal sensory neuropeptide calcitonin gene-related peptide (CGRP) in blood vessels within the brain, its lining and the brainstem, and to suppress signaling in pain neurons. We believe 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 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.”
In addition to TNX-1900, the company is developing a different intranasal oxytocin formulation, TNX-2900 for the treatment of Prader-Willi syndrome, which Tonix licensed from the French National Institute of Health and Medical Research (Inserm) in February 2021.
Read the Tonix Pharmaceuticals press release.
