Argenica Therapeutics Secures $12M to Advance Phase 2 Trial for Ischaemic Stroke Patients

Argenica Therapeutics Ltd (ASX:AGN) has binding commitments to raise $12 million before costs at $0.52 per share.

The placement was strongly supported by large existing shareholders, new institutional investors, family offices, and sophisticated high-net-worth investors.

The company is developing novel neuroprotective therapeutics to reduce brain tissue death after a stroke and other devastating brain injuries.

Every 19 minutes someone in Australia will suffer a new stroke.

To put this into perspective, one in four people with suffer a stroke in their lifetime.

Unfortunately, only 10% will recover almost completely, due to the extent of brain cell damage.

Advancing research

Argenica is now fully-funded to complete its Phase 2 trial of its lead neuroprotective peptide candidate ARG-007 in ischaemic stroke patients.

There has already been the successful dosing of the first five patient cohort with no adverse events reported.

The study will be double-blinded, randomised and placebo-controlled.

ARG-007 has been successfully demonstrated to improve outcomes in pre-clinical stroke models, traumatic brain injury (TBI) and hypoxic ischaemic encephalopathy (HIE).

Funds will also be allocated to progress the company’s other indications and regulatory activities.

Unmet need

There are no marketed drugs that protect the brain after stroke, and ARG-007 aims to fill this urgent and unmet clinical need.

Current markets cater to the treatment and diagnosis of stroke, not protecting brain cells.

FDA

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) status to ARG-007 for the treatment of HIE.

The ODD qualifies Argenica for incentives including tax credits for qualified clinical trials, exemption from user fees and the potential for seven years of market exclusivity after approval.

Therefore the granting of the ODD for ARG-007 in HIE forms a key pillar of the company’s commercialisation strategy.

 

 

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