Tonix Pharmaceuticals Holding Corp. products

TNX-1300 (recombinant T172R/G173Q double-mutant cocaine esterase 200 mg, IV solution) is being developed under an Investigational New Drug application (IND) for the treatment of cocaine intoxication. It has been designated a Breakthrough Therapy by the FDA. Currently there is no specific pharmacotherapy indicated for cocaine intoxication, a state characterized by acute agitation, hyperthermia, tachycardia, arrhythmias, and hypertension, with the potential life-threatening sequalae of myocardial infarction, cerebrovascular accident, rhabdomyolysis, respiratory failure, and seizures. Patients are currently managed only by supportive care for the adverse effects of cocaine overdose on the cardiovascular and central nervous systems.

TNX-1900, Tonix’s proprietary potentiated intranasal oxytocin is in the pre-Investigational New Drug (IND) stage and is currently being studied as a candidate for prophylaxis of chronic migraine.

TNX-102 SL is a small, rapidly-disintegrating, under the tongue (sublingual) product candidate containing 2.8 mg of cyclobenzaprine HCl. The unique patented formulation has been designed to optimize the delivery and absorption of cyclobenzaprine for the therapeutic benefit of improving sleep quality, while minimizing the potential residual effects of oral formulations of cyclobenzaprine. TNX-102 SL is a centrally acting analgesic that helps in relieving pain by improving sleep.

TNX-601 ER is a novel oral formulation of tianeptine hemioxalate that is being developed as a potential treatment for major depressive disorder (MDD), posttraumatic stress disorder (PTSD) and neurocognitive dysfunction associated with corticosteroid use. Tonix’s TNX-601 ER includes tianeptine hemioxalate in an extended-release formulation.

TNX-1500 is a humanized monoclonal antibody (mAb) directed against CD40-ligand, which is also known as CD154, T-BAM, 5c8 antigen, TRAP and gp39. TNX-1500 incorporates the antigen binding fragment (Fab) region of hu5c8 (recombinant monoclonal antibody to CD40-ligand), that has been extensively characterized at the molecular level in complex with the CD40-ligand. TNX-1500 is being studied and evaluated for its role in preventing or treating organ transplant rejection and for treating autoimmune disorders.