Tonix Pharmaceuticals (NASDAQ:TNXP) announced the first patient dosing in its Phase 2 trial of the recombinant enzyme TNX-1300 for treating life-threatening cocaine intoxication in patients presenting to the emergency department. The company anticipates topline results in the first half of 2025.
Tonix has been awarded a Cooperative Agreement Grant from the National Institute on Drug Abuse, a division of the NIH, to support the development of TNX-1300 for treating cocaine intoxication. Additionally, TNX-1300 has received Breakthrough Therapy designation from the FDA.
In a statement, Seth Lederman, M.D., and CEO of Tonix, said, “Cocaine abuse and dependence are major problems in the U.S. However, there is currently no FDA-approved treatment indicated for cocaine intoxication, a life-threatening state characterized by acute symptoms including agitation, hyperthermia, tachycardia, arrhythmias, hypertensive crisis, myocardial infarction, stroke, and seizures.”
Dr. Lederman added, “In 2022, the number of overdose deaths involving cocaine reached 27,569 individuals. With approximately 505,000 emergency room visits annually involving cocaine use and approximately 61,000 of the visits involving detox services to treat cocaine overdose, we believe TNX-1300 has the potential to help address the morbidity and mortality caused by cocaine intoxication. By targeting the cause rather than the symptoms of cocaine intoxication, TNX-1300 may offer significant advantages to the current standard of care for cocaine overdose.”
