Argenica Therapeutics (ASX: AGN) has reported positive results from a drug-to-drug interaction assessment showing its lead candidate ARG-007 does not interfere with clot-dissolving agent tenecteplase (TNK) in the treatment of acute ischemic stroke.
Argenica conducted the assessment in response to the FDA’s clinical hold on an investigational new drug (IND) application pending the results of additional studies and information on ARG-007’s safety and tolerability.
It aimed to determine whether the neuroprotective therapy interferes with the clot-dissolving activity of TNK—a genetically modified version of standard-of-care drug alteplase, a recombinant tissue plasminogen activator the FDA recently approved for the treatment of acute ischemic stroke.
Whole-Blood Clot Evaluation
Argenica’s assessment evaluated whole-blood clots from four human donors (two males and two females) to determine whether ARG-007 would inhibit TNK-induced thrombolysis.
The tests used aminocaproic acid—a well-known inhibitor of fibrinolysis (clot-dissolving activity) that reliably blocks the clot-dissolving effect of TNK—as a positive control.
Across all four donors and eight concentrations of ARG-007, spanning from low to high doses, the drug was shown to not inhibit TNK’s mechanism of action.
The findings support the overall safety profile of the drug, while representing a critical step toward resolving the FDA’s questions.
Meeting FDA Requirements
Argenica confirmed the findings would meet the FDA requirements, significantly de-risking ARG-007’s development for use alongside standard-of-care clot-dissolving agents.
The company will use the data to assist its preparations for the next clinical study, with additional safety and dosing data used to strengthen the IND package.
Argenica plans to generate additional data on the maximum tolerated dose of ARG-007 in rats to inform the clinical safety margin for dosing in humans.
The company is also moving toward its next planned clinical study of ARG-007, ensuring that operational, regulatory, and manufacturing readiness is in place to enable rapid progression towards commercialisation once the IND hold is lifted.
