Australian biotechnology company Argenica Therapeutics has received a final Phase I trial report for ARG-007, its drug candidate for acute neurological conditions.
The report from clinical research organisation Linear Clinical confirms that the drug is safe for patient administration and has a favourable pharmacokinetics (PK) profile.
It concluded that single intravascular ARG-007 doses of 0.03, 0.10, 0.20 and 0.30 mg/kg were safe and well-tolerated.
No dose-related findings were recorded for any of the evaluated safety parameters.
ARG-007’s PK profile was evaluated using blood samples collected from the time of initiation to 48 hours, with the drug concentration analysed in the blood plasma at each specific timepoint.
The human PK data showed that exposure levels and timing of drug concentration in the plasma aligned with the animal PK data.
ARG-007’s rapid uptake indicates that its fast-acting nature meets critical requirements for neuroprotective drugs used to treat acute neurological conditions such as acute ischaemic stroke and hypoxic ischaemic encephalopathy (HIE).
The drug was also shown to have an extended half-life, suggesting prolonged efficacy at the effect site.
Argenica managing director Dr Liz Dallimore said: “We now have quality assured data showing ARG-007 is safe and well-tolerated in humans, and is fast acting, reaching its maximum concentration in the blood at ten minutes but with a relatively long half-life to exert its action for longer.
“With 1.9 million brain cells dying every minute after stroke, time to maximum drug concentration is critical.”
Successful data obtained from the Phase I trial will be used in Argenica’s dose selection for the Phase II trial.
The company expects to file an ethics submission for initiating a Phase II trial in patients with ischaemic stroke in the third quarter of this year.
It began dosing patients in the trial’s third cohort in November last year.