US-based Tonix Pharmaceuticals has dosed the first patient in a Phase II trial evaluating a treatment for acute cocaine intoxication in emergency settings.
The company is investigating its asset TNX-1300 in the single-blind, placebo-controlled, proof-of-concept trial (NCT06045793) compared to placebo in patients in the emergency department.
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The study is being conducted in emergency departments of six academic medical centres across the US and aims to enrol 60 subjects presenting with cocaine intoxication.
Patients will either receive a single intravenous (IV) injection of 200mg TNX-1300 or an IV injection, the latter being the current standard of care.
Following treatment, blood samples will be drawn at specific time points to assess the pharmacokinetics of TNX-1300 and levels of cocaine and its metabolites in the plasma.
The primary endpoint of the study is the change from baseline in systolic blood pressure an hour after dosing, as per ClinicalTrials.gov. Secondary endpoints include heart parameter measurements and intoxication assessments based on the Stimulant Intoxication Scale.
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By GlobalDataTNX-1300’s development is being supported by the National Institutes of Health (NIH), according to Tonix. The asset has also been granted breakthrough therapy designation by the US Food and Drug Administration (FDA).
TNX-1300 is a double-mutant cocaine esterase produced through recombinant DNA technology. The enzyme was identified in a type of bacteria called Rhodococcus that uses cocaine as its sole source of carbon and nitrogen from surrounding coca plants. Cocaine esterase catalyses the breakdown of cocaine into compounds with lower toxicity.
Tonix’s drug is active for approximately six hours at body temperature, unlike wild-type versions of the enzyme that is unstable at the same temperature.
Tonix’s CEO Seth Lederman said: “There is currently no FDA-approved treatment indicated for cocaine intoxication. 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.”
