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- Argenica Therapeutics (AGN) confirms its drug ARG-007 is safe and well-tolerated after completing its phase one clinical trial
- The drug is intended for the treatment of acute neurological conditions, including acute ischaemic stroke and hypoxic ischaemic encephalopathy (HIE)
- The study report showed ARG-007 absorbs within the first 10 minutes of infusion, before decreasing after 30 minutes and has an extended half-life of up to 15 hours
- AGN is now working towards a final application for Human Research Ethics Committee approval to commence a phase two clinical trial in acute ischaemic stroke patients
- AGN shares last traded at 42 cents at 10:55 am AEST
Biotech company Argenica Therapeutics (AGN) has confirmed its drug, ARG-007, is safe and well-tolerated its final phase one clinical trial report.
The company received receipt of its final phase one clinical trial report provided by clinical research organisation Linear Clinical.
The clinical report concluded that single intravascular doses of ARG-007 ranging from 0.03 to 0.3 milligrams of medication per kilogram (mg/kg) were safe and well-tolerated, with no adverse reactions observed.
The drug is intended for the treatment of acute neurological conditions, including acute ischaemic stroke and hypoxic ischaemic encephalopathy (HIE).
Pharmacokinetic analysis revealed the drug was rapidly absorbed within the first ten minutes of infusion, before decreasing after 30 minutes. It was also shown to have an extended half-life in which the drug remains in the body of 12 to 15 hours, allowing for a prolonged therapeutic effect.
This led the company to conclude the pharmacokinetic profile in humans is aligned with the pharmacokinetic profile seen at the effective doses tested in animals.
Argenica Managing Director Doctor Liz Dallimore said the final phase one clinical trial report was a “huge milestone” for the company.
“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,” Dr Dallimore said.
“With 1.9 million brain cells dying every minute after stroke, time to maximum drug concentration is critical.”
AGN is now working towards a final application for Human Research Ethics Committee approval to commence a phase Itwo clinical trial in acute ischaemic stroke patients, to be submitted by the third quarter of 2023.
AGN shares last traded at 42 cents at 10:55 am AEST.
