Argenica (ASX:AGN) continues on pace for pivotal Australian stroke trials

Argenica Therapeutics now has eight of 10 sites now online as phase 2 clinical trials for proving neuroprotective treatment ARG-007’s efficacy against stroke continues across Australia’s hospitals.

The remaining two hospitals are set for activation by month’s end and, since marking the first dosing at the end of March, a score of patients have now been recruited and dosed.

Proven safe in healthy patients through phase 1, the secondary trial is directed at testing safety in acute ischaemic stroke patients and generating preliminary data on the therapeutic’s ability to reduce brain tissue death after stroke and the removal of a clot.

After the first five patients reported no adverse events, the Data Safety Monitoring Board recommended the pivotal trials continue as planned and will soon reconvene once dosing hits the 23-patient mark.

Having all hospitals online will facilitate greater recruitment of patients presenting to hospital emergency departments with diagnosed strokes, with recruitment is on track to finish dosing 92 patients by the end of 2025.

Argenica Managing Director Dr Liz Dallimore said the company was delighted with the trial’s progress to date.

“We are very encouraged by the fact that recruitment is progressing well, and the investigators at the hospitals that have recruited patients have all been extremely positive about the study protocol,” she said.

“We look forward to having all trial sites activated and recruiting patients in the coming weeks, which will give us greater clarity on patient recruitment rates and when we can expect to complete the study. We will continue to provide trial updates as recruitment of patients progresses.”

ARG-007 has been long in the making since a Western Australian research team discovered that certain peptides could limit brain damage after a stroke.

With little treatment of its kind on the market, confirmation of efficacy would position the drug as a leading candidate against stroke, and earlier-stage trials have continued to show a wider-spanning potential for other neurological impairments.

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