Tonix Pharmaceuticals Licenses TNX-4900, Novel Sigma-1 Receptor Antagonist for Chronic Neuropathic Pain
Key Insights
Tonix Pharmaceuticals (search) has licensed exclusive worldwide rights to TNX-4900 (search), a highly selective Sigma-1 receptor (search) antagonist developed at Rutgers University for treating chronic neuropathic pain (search).
The compound demonstrated significant analgesic efficacy in preclinical models of diabetic and chemotherapy-induced neuropathic pain (search) without evidence of tolerance or motor impairment.
TNX-4900 (search) binds the human Sigma-1 receptor (search) with nanomolar affinity and exhibits favorable pharmacokinetic properties, including 28% oral bioavailability.
Tonix Pharmaceuticals (search) Holding Corp. has announced the licensing of exclusive worldwide rights to TNX-4900 (search), a highly selective small-molecule Sigma-1 receptor (search) antagonist with demonstrated analgesic activity in multiple models of neuropathic pain (search). The compound, formerly known as PW507, was developed through a structure-based drug design program at Rutgers University.
Novel Mechanism for Non-Opioid Pain Management
TNX-4900 (search) represents a promising new class of non-opioid, non-addictive analgesics targeting the Sigma-1 receptor (search). "Sigma-1 receptor antagonism has generated considerable scientific interest as a promising class of non-opioid, non-addictive analgesics," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals (search). "With our extensive experience studying and developing an FDA approved non-opioid analgesic we are well-positioned to oversee this new development program. We believe TNX-4900 has the potential to be best-in-class."
The compound was created through computer-aided and AI-driven approaches led by Dr. Youyi Peng and Dr. William Welsh at Rutgers University. Dr. Youyi Peng, co-inventor of TNX-4900 (search) and now a consultant to Tonix, noted that "TNX-4900 showed robust analgesic efficacy in multiple pain models and an encouraging safety profile, supporting its potential as a new non-opioid approach to treating neuropathic pain (search)."
Compelling Preclinical Profile
TNX-4900 (search) demonstrates exceptional selectivity and potency characteristics. The compound binds the human Sigma-1 receptor (search) with nanomolar affinity (Ki = 7.5 nM) and demonstrates greater than 100-fold selectivity over the Sigma-2 receptor. Additionally, it exhibits high blood-brain barrier penetration and favorable adsorption, distribution, metabolism and elimination (ADME) properties, including oral bioavailability of approximately 28%.
In preclinical studies, TNX-4900 (search) produced significant and durable reductions in pain behaviors in models of diabetic and chemotherapy-induced neuropathic pain (search) after both acute and chronic dosing. Importantly, the compound showed no evidence of tolerance or motor impairment, addressing key limitations of current pain management approaches.
Development Strategy and Company Portfolio
Dr. William Welsh, Distinguished Professor in the Department of Pharmacology at Rutgers Robert Wood Johnson Medical School, emphasized the significance of this research: "Our foundational research into TNX-4900 (search) represents an important step toward developing non-opioid solutions for chronic pain. We are pleased to see this innovation progress toward potential clinical application, which could address a critical need for safer pain management options."
Tonix plans to advance TNX-4900 (search) through expanded pharmacokinetic, formulation, and safety studies to support IND-enabling development. The company brings relevant experience to this program, having successfully developed and commercialized TONMYA (search), an FDA-approved first-in-class, non-opioid analgesic medicine for fibromyalgia (search) treatment. TONMYA represents the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years.
The licensing of TNX-4900 (search) expands Tonix's development portfolio focused on central nervous system disorders, which includes ongoing programs for acute stress reaction, acute stress disorder, and major depressive disorder. The company also maintains active development programs in immunology, immuno-oncology, rare disease, and infectious disease areas.