Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced the publication of new preclinical research in the peer-reviewed Journal of Virology that demonstrates significant differences in virulence between mpox virus clade IIb—the strain currently circulating in the U.S.—and the historic clade IIa strain. Conducted at the company's research and development center, the study identified three new mouse models for investigating mpox pathogenesis and found that the clade IIb isolate is up to 100,000 times less virulent than clade IIa. These findings provide additional tools to evaluate vaccines and other medical countermeasures against mpox.
The research supports continued development of TNX-801, Tonix's live attenuated horsepox virus vaccine candidate for the prevention of mpox and smallpox. The company believes the new animal models will help researchers better understand emerging mpox variants, assess vaccine durability and protective efficacy, and advance efforts to address the ongoing global threat posed by the disease. The full press release is available at https://ibn.fm/ZlMk.
Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. The company's recently approved flagship medicine, TONMYA (cyclobenzaprine HCl sublingual tablets 2.8mg), is the first new treatment for fibromyalgia in more than 15 years. Tonix's CNS commercial infrastructure supports its marketed products, including its acute migraine products Zembrace SymTouch and Tosymra. The company is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder.
In addition, Tonix's CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. The company is also advancing a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. These product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
This research is particularly important as it addresses the need for better animal models to study mpox, which continues to pose a global health threat. By demonstrating the substantial virulence difference between clades, the study provides a foundation for developing more effective vaccines and treatments. The implications for public health are significant, as improved countermeasures could help prevent future outbreaks and protect vulnerable populations.
