Drug intelligence / Profile preview

TNX-1300

Development stage
Phase 2
Lead developer
Tonix Pharmaceuticals
Modality
Replacement Enzymes → Therapeutic Enzymes → Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

TNX-1300 is a recombinant protein enzyme (recombinant T172R/G173Q double-mutant cocaine esterase) produced through recombinant DNA technology in a non-disease-producing strain of *E. coli* bacteria. It is derived from a bacterial enzyme originally identified in *Rhodococcus* species that use cocaine as their sole carbon and nitrogen source. TNX-1300 rapidly and efficiently degrades and metabolizes cocaine in the bloodstream by catalyzing its breakdown into ecgonine methyl ester and benzoic acid, thereby reducing the risk of life-threatening toxicity associated with acute cocaine intoxication. The wild-type enzyme was engineered to improve stability at human body temperature via targeted mutations (T172R/G173Q), resulting in an active duration of approximately 6 hours. TNX-1300 is being developed for the treatment of acute cocaine intoxication/overdose, for which there are currently no approved specific pharmacotherapies; current management relies on supportive care only. The drug has received Breakthrough Therapy designation from the FDA and development support from the National Institute on Drug Abuse (NIDA). It is currently undergoing Phase II clinical trials for this indication[1][2][3][5][6].

Other names
recombinant T172R/G173Q double-mutant cocaine esterasecocaine esteraseCocE
02

Targets

CocE (Cocaine esterase)

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