Tonix Pharmaceuticals Announces First Participant Dosed in Phase 1 Study of TNX-1900 for Migraine and Craniofacial Pain
Tonix Pharmaceuticals: First Participant Dosed in Phase 1 Pharmacodynamic Study of TNX-1900 (Intranasal Potentiated Oxytocin) for Migraine and Craniofacial Pain
Key Highlights
- Tonix Pharmaceuticals (Nasdaq: TNXP) has announced the dosing of the first participant in a Phase 1 investigator-initiated study for TNX-1900, an intranasal potentiated oxytocin formulation.
- The study aims to assess TNX-1900’s effects in treating migraine and craniofacial pain, using a trigeminal neurovascular reactivity model.
- Laser Speckle Contrast Imaging (LSCI) will be used to measure forehead skin blood flow response to capsaicin and electrical stimulation, offering real-time, high-resolution dermal blood flow measurements.
- Oxytocin’s mechanism of action is distinct from the CGRP inhibitor class currently available for migraines, targeting a separate pathway.
- The research is a collaboration with Dr. Antoinette Maassen van den Brink, Professor of Neurovascular Pharmacology at Erasmus University Medical Center.
- The study’s outcome may guide future development of TNX-1900 as a potential non-opioid treatment for migraine and other craniofacial pain conditions.
Detailed Study Information
- In animal models, intranasal oxytocin binds to receptors in the trigeminal ganglion, blocking the release of calcitonin gene-related peptide (CGRP), a key player in migraine pathogenesis.
- Previous research demonstrates that CGRP inhibitors and triptans can inhibit forehead dermal blood flow in response to capsaicin, validating the study’s model for human migraine and pain response.
- The LSCI technique recently validated by Dr. Maassen van den Brink’s team is a significant advancement, allowing for improved measurement over earlier Laser Doppler Perfusion Imaging methods.
- Oxytocin may present a new therapeutic option, targeting pathways distinct from both triptan and CGRP inhibitor drug classes, addressing unmet needs in migraine treatment.
About Migraine – Market Opportunity
- Migraine affects approximately 1.2 billion individuals globally annually, with 39 million Americans suffering from migraines and about four million experiencing chronic migraines (≥15 headache days/month).
- This represents a massive, underserved market for effective, non-opioid treatments.
About TNX-1900
- TNX-1900 is a proprietary, intranasal combination of oxytocin and magnesium, designed to enhance oxytocin receptor binding and inhibit trigeminal neuron activity.
- Unlike CGRP receptor antagonists and anti-CGRP antibody drugs, TNX-1900’s mechanism blocks CGRP release at the trigeminal ganglion, promising selective action and potentially improved safety.
- Intranasal delivery concentrates oxytocin in the trigeminal system, resulting in low systemic exposure and lower risk of off-target effects (e.g., cardiovascular risks associated with systemic CGRP inhibition).
- Daily dosing is rapidly reversible, unlike monthly or quarterly anti-CGRP antibody treatments, offering greater physician and patient control.
- TNX-1900 is also being developed for other indications, including binge eating disorder, adolescent obesity, bone health in pediatric autism, and arginine-vasopressin deficiency.
- Tonix holds a license from the University of Geneva to use TNX-1900 for insulin resistance and related conditions.
Tonix Pharmaceuticals Pipeline and Commercial Portfolio
- Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotech focused on CNS and immunology treatments.
- The company has launched TONMYA® (cyclobenzaprine HCl) for fibromyalgia, and markets Zembrace® Symtouch® and Tosymra® for acute migraine.
- Tonix’s CNS pipeline includes TNX-2900 (intranasal oxytocin) for Prader-Willi syndrome (Phase 2 ready), and TNX-4800 (long-acting monoclonal antibody) for Lyme disease prophylaxis, as well as TNX-1500 (CD40 ligand inhibitor) for kidney transplant rejection prevention.
Potential Price-Sensitive Information for Investors
- Initiation of Phase 1 Study: The dosing of the first participant in the TNX-1900 study is a significant milestone and may be viewed positively by investors as it demonstrates progress in Tonix’s clinical pipeline.
- Novel Mechanism and Market Differentiation: TNX-1900 targets a pathway distinct from existing migraine treatments, potentially addressing unmet medical needs and offering a competitive advantage.
- Large Addressable Market: With migraine affecting millions globally, successful development and commercialization of TNX-1900 could be highly lucrative for Tonix.
- Safety Advantage: Nasal delivery of oxytocin may reduce systemic side effects and cardiovascular risks, a notable concern with current CGRP inhibitors.
- Versatile Applications: TNX-1900 is being developed for multiple indications beyond migraine, increasing its commercial potential.
Forward-Looking Statements and Risks
- The press release includes forward-looking statements regarding the completion of clinical trials, regulatory approvals, commercialization, and other business activities.
- Risks include failure to obtain FDA approvals, commercialization challenges, need for additional financing, patent protection uncertainties, reimbursement issues, and competition.
- Investors are cautioned that all product development candidates, including TNX-1900, are investigational and have not been approved for any indication.
Contact Information
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Disclaimer
This article is intended for informational purposes only and does not constitute investment advice. All forward-looking statements are subject to significant risks and uncertainties, including regulatory, clinical, financial, and competitive risks. Tonix Pharmaceuticals’ product development candidates are investigational and have not been approved for any indication. Investors should conduct their own due diligence and consult with financial professionals before making investment decisions. The information herein reflects the facts as of the date of publication and may change without notice.
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