Tonix Pharmaceuticals has no tonic for cocaine intoxication, with the biopharma terminating a midstage trial for the condition amid poor trial enrollment.
The investigational drug in question, TNX-1300, had snagged an FDA breakthrough therapy designation to treat cocaine intoxication and overdose.
In a Securities and Exchange Commission filing made public Friday, however, Tonix said it has discontinued enrollment and terminated the study, dubbed Catalyst.
The trial was set up in an emergency department, but enrollment in this setting “was slower than projected,” Tonix said in the filing, noting that the related trial termination was not due to safety or efficacy concerns.
The investigational therapy works as a recombinant protein enzyme via a non-disease-producing strain of E. coli bacteria.
Tonix said that there is no specific pharmacotherapy indicated for cocaine intoxication, which can prompt life-threatening risks including heart attacks, respiratory failure and seizures.
It’s not curtains yet for TNX-1300, as Tonix added that it will be “evaluating new study designs and new endpoints for further development” of the drug, though the company did not give specifics.
In 2022, the biopharma had received financing for the study from the U.S. government via a pact with the National Institute on Drug Abuse, part of the National Institutes of Health.
Tonix is no stranger to drug and trial setbacks. At the end of 2023, the company dropped a major depression disorder therapy after the drug flamed out of a phase 2 trial.
A few months prior, Tonix abandoned testing out a cyclobenzaprine drug for fibromyalgia-like long COVID after the asset failed to show a statistically significant improvement in pain symptoms.
There however may be reprieve for that therapy, called TNX-102 SL, on the horizon. Tonix is gearing up for what it hopes will be an FDA approval for the med in fibromyalgia, with an FDA decision date expected before or by Aug. 15.