New data from AI-driven re-analysis of the Phase 2 clinical trial results by Argenica Therapeutics has confirmed that the neuroprotective drug ARG-007 delivers its strongest benefit in more severe cases of ischemic stroke.
Ischaemic stroke, the most common type, occurs when a blood clot or fatty deposit blocks blood flow to the brain.
Discovered by Prof Bruno Meloni at The University of Western Australia and WA’s Perron Institute, ARG-007 aims to protect brain cells and reduce cell death following a stroke and other types of brain injury.
Argenica, the WA-based biotechnology company developing this novel therapeutic, reported that when scoring of stroke severity was standardised through application of the AI tool, ARG-007’s potential to meaningfully improve functional independence in patients with substantial brain injury on presentation to hospital was demonstrated.
As well as statistically significant improvements in functional outcomes for clinical trial participants recovering from more severe stroke, the ARG-007 treatment, compared with a placebo, also resulted in significantly lower follow up volumes of brain tissue death.
“Reduced brain tissue death is a defining hallmark of neuroprotection and a key validation of ARG-007’s mechanism of action,” said Argenica’s Managing Director, Dr Liz Dallimore.
“We are extremely excited by the outcomes of this analysis from Brainomix, a company at the forefront of data and imaging analysis in stroke clinical trials.
“Severe acute ischaemic stroke patients have the highest unmet need as they tend to have poorer outcomes after thrombectomy (clot removal).
“ARG-007’s demonstrated efficacy for these clinical trial participants highlights its potential to become the first adjunctive neuroprotective therapy to improve outcomes for this highest-need segment.
“This AI-enabled precision analysis approved by the United States Food and Drug Administration accurately classifies enrolled trial participants based on stroke severity when they first present to the emergency department.
“We are excited to progress to the next stage of development having the confidence to design a more targeted Phase 2b clinical trial of our lead neuroprotective therapy ARG-007,” Dr Dallimore said.
Based on an Argenica Therapeutics ASX announcement