Tonix Initiates Phase 1 Study Of TNX-1900 Targeting Trigeminal Neurovascular Activity

Tonix Pharmaceuticals Holding Corp. announced that the first participant has been dosed in a Phase 1 investigator-initiated study evaluating TNX-1900, an intranasal potentiated oxytocin therapy. The study aims to assess its effect on trigeminal nerve-mediated vasodilation in healthy female volunteers, using capsaicin and electrical stimulation as models for trigeminal neurovascular activity.

The study is being led by Antoinette Maassen van den Brink at Erasmus University Medical Center, who serves as both principal investigator and sponsor under a collaborative agreement with Tonix. The research focuses on understanding how TNX-1900 may modulate neurovascular responses underlying migraine mechanisms.

“We are excited to collaborate with Professor Maassen van den Brink on this proof-of-concept study investigating the potential for TNX-1900 for treating migraine, craniofacial pain, and other related conditions,” said Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals. “While there are several CGRP inhibitors approved for the treatment of migraine, TNX-1900’s oxytocin treatment affects a distinct pathway that could address unmet needs. The results of the new study will guide future development of this potential non-opioid treatment for migraine and other craniofacial pain conditions.”

Preclinical findings suggest that intranasal oxytocin can act on receptors in the trigeminal ganglion, potentially inhibiting the release of calcitonin gene-related peptide (CGRP), a key factor in migraine-related vasodilation. Previous research by Dr. Maassen van den Brink has also demonstrated that CGRP inhibitors and triptans can reduce trigeminal-mediated blood flow responses.

Doppler Perfusion Imaging used in earlier studies,” said Dr. Maassen van den Brink. “Oxytocin represents a potential new therapeutic option, targeting a pathway in migraine and craniofacial pain that is distinct from both the triptan and CGRP inhibitor migraine treatment drug classes.”

To support this study, the research team has validated the use of Laser Speckle Contrast Imaging (LSCI), a technique for measuring dermal blood flow, within this neurovascular model, enhancing the ability to monitor treatment effects in real time.