Tonix is a clinical-stage biopharmaceutical company focused on bringing novel therapeutics and diagnostics to prevent and treat central nervous system disorders, immunology conditions, infectious diseases, and rare diseases.
At Tonix, we are focused on identifying and developing candidates that have the promise to treat and prevent human disease and alleviate suffering. Through our own development, in-licensing, collaborations and acquisitions we are curating an innovative and effective portfolio that targets the relief of pain and attenuates infection. Currently, our pipeline is primarily comprised of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Our infectious disease portfolio includes COVID-19 next-generation vaccines to prevent COVID-19, an antiviral to treat COVID-19, and a potential treatment for Long COVID. We are progressing small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions through our CNS portfolio.
Central Nervous System
Tonix’s lead CNS candidate, TNX-102 SL1 (sublingual formulation of cyclobenzaprine) is in mid-Phase 3 development for the management of fibromyalgia, a disorder characterized by chronic musculoskeletal pain, sleep deprivation, fatigue and mood changes. Tonix reported positive results from a Phase 3 study of TNX-102 SL in fibromyalgia in December 2020. TNX-102 SL is also being developed for Long COVID.
Tonix’s lead infectious disease product candidate is a potential vaccine for COVID-19, TNX-1840/TNX-18502. This candidate is a live replicating vaccine based on Tonix’s recombinant pox vaccine (RPV) platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix is also working on TNX-8012, a live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox.
TNX-2900, Tonix’s proprietary potentiated intranasal oxytocin, is in development for the treatment of Prader-Willi syndrome (PWS), the most common genetic cause of life-threatening childhood obesity. TNX-2900 has been granted Orphan Drug Designation (ODD) in the US by the FDA for the treatment of PWS.