• Argenica Therapeutics (AGN) completes the dosing stage of a phase one clinical trial of its ARG-007 product to reduce brain tissue death after stroke and injury
• The news marks the completion of Argenica’s fourth and final cohort dosing, which saw six healthy participants dosed with ARG-007 and two receive a placebo
• Throughout the trial, all four doses of the treatment were shown to be well-tolerated by patients, with no serious adverse events observed
• As such, the fourth cohort has been given the tick of approval from the trial’s safety review committee (SRC)
• All trial data will now be compiled and analysed by March 2023 ahead of a final clinical report in May
• Argenica Therapeutics shares are up 5.49 per cent to 48 cents at 11:44 am AEDT

Argenica Therapeutics (AGN) has completed the dosing stage of a phase one clinical trial of its ARG-007 product to reduce brain tissue death after stroke and injury.

The news marks the completion of Argenica’s fourth and final cohort dosing, which saw six healthy participants dosed with ARG-007 and two receive a placebo.

Throughout the trial, all four doses of ARG-007 were shown to be well tolerated by patients, with no serious adverse events observed, resulting in the fourth cohort being given the tick of approval from the trial’s safety review committee (SRC).

Argenica CEO and Managing Director Liz Dallimore said the completion of dosing in the company’s phase one clinical trial was a “pivotal milestone” for the company.

“This is incredibly exciting for the company, as it now paves the way for Argenica to test ARG-007 not only in stroke patients but also patients with other neurological conditions where a single dose of ARG-007 has already shown efficacy in preclinical studies,” she said.

“This includes conditions such as hypoxic ischaemic encephalopathy, cardiac arrest, and severe traumatic brain injury.”

The company and the SRC have now received further information on non-serious adverse events from the trial clinical research organisation, Linear Clinical Research.

Linear will now work to compile all trial data and prepare an interim analysis report to be completed in March 2023, ahead of returning a final clinical study report to Argenica by May 2023.

The clinical study report will provide the data required for Argenica to submit the Phase two ethics application.

Meanwhile, the company has begun planning for its phase two clinical trial in ischaemic stroke patients, to be conducted across multiple hospitals in Australia.

Argenica Therapeutics shares were up 5.49 per cent to 48 cents at 11:44 am AEDT.