Argenica Therapeutics Releases Positive Safety Data from Phase 2 ARG-007 Stroke Trial

Perth-based biotech Argenica Therapeutics (ASX: AGN) has released top-line safety results from its Phase 2 trial evaluating lead candidate ARG-007 on patients with acute ischaemic stroke (AIS) who are undergoing mechanical removal of a blood clot in the brain.

The multi-centre, double-blind, randomised, placebo-controlled, single-dose clinical study conducted by the company’s clinical research organisation ProPharma found ARG-007 to be generally well-tolerated in a single dose with no statistically-significant difference in treatment-emergent adverse events between active participants and the placebo group.

The trial also confirmed there was no drug-to-drug interaction with clot-dissolving medications such as Alteplase or Tenecteplase, meaning ARG-007 could safely be delivered to patients receiving these treatments.

Full Phase 2 Data Analysis

Argenica will supplement its full analysis of the Phase 2 trial data including patient sub-populations with further pre-clinical data to gather more information on efficacious doses and timing of delivery.

AI-powered stroke diagnostic company Brainomix will also participate to provide greater insights to the data, and Argenica expects to receive the results by year end and will then use those findings to assist in developing a targeted design for a pivotal Phase 3 trial.

Argenica remains well-funded to advance its ARG-007 program towards further data points with current cash of $7 million and is anticipating a research and development tax refund of as much as $4m.

Milestone Development

Managing director Dr Liz Dallimore said the positive safety data represented a significant milestone in the drug’s clinical development.

“Passing the safety endpoint was of the utmost importance in this trial as it gives us confidence of the drug’s safety when being explored for indications outside of stroke such as traumatic brain injury and hypoxic-ischemic encephalopathy,” she said.

“We have investigated the underlying signals of efficacy to determine which patient group responds best and we are delighted to have seen an efficacy signal in the most at-risk patients with slow collateral circulation who are in most need of a neuroprotection drug.”

Dr Dallimore said around 30% of AIS patients with large vessel occlusion have poor or slow collateral blood supply, where insufficient blood gets through to the affected parts of the brain meaning the brain tissue dies faster.

“We are now one step closer to ARG-007’s potential to address a significant unmet need in stroke treatment,” she added.