Tonix Pharmaceuticals (TNXP) Doses First Patient in Phase 2 Study for Treating Cocaine Intoxication
Tonix Pharmaceuticals Holding Corp. (TNXP), an integrated biopharmaceutical and PRISM Pharma Index company with both marketed products and a pipeline of development candidates, Ā announced today that the first patient has been dosed in a Phase 2, single-blind, placebo-controlled proof-of-concept trial of TNX-1300. This trial is investigating TNX-1300, a double-mutant cocaine esterase (200 mg, i.v. solution), as a treatment for acute cocaine intoxication in emergency departments (EDs). TNX-1300 is a recombinant enzyme that rapidly degrades and metabolizes cocaine in users, a capability demonstrated in a previous Phase 2a randomized, double-blind, placebo-controlled, laboratory-based clinical study, supporting its potential as a life-saving treatment for cocaine intoxication.
Tonix has received a Cooperative Agreement Grant from the National Institute on Drug Abuse (NIDA), a part of the National Institutes of Health (NIH), to support the development of TNX-1300 for this indication. Furthermore, the U.S. Food and Drug Administration (FDA) has granted TNX-1300 Breakthrough Therapy designation.
“Cocaine abuse and dependence pose significant challenges in the U.S., yet there is no FDA-approved treatment for cocaine intoxication, a life-threatening condition marked by symptoms such as agitation, hyperthermia, tachycardia, arrhythmias, hypertensive crisis, myocardial infarction, stroke, and seizures,” stated Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “In 2022, cocaine-related overdose deaths reached 27,569. With around 505,000 emergency room visits annually involving cocaine use and approximately 61,000 of these requiring detox services for cocaine overdose, TNX-1300 could potentially reduce the morbidity and mortality associated with cocaine intoxication. By addressing the root cause rather than just the symptoms, TNX-1300 may offer substantial advantages over the current standard of care for cocaine overdose.”