Argenica (ASX:AGN) receives paediatric approval from FDA for infants therapeutic that aims to save lives

Argenica Therapeutics’ neuroprotective drug ARG-007 has received a Pediatric Disease Designation from the United States Food and Drug Administration for treatment of hypoxic ischaemic encephalopathy, a rare, devastating condition which limits blood flow to the brains of newborn infants.

About 40 to 60 per cent of youngsters affected by HIE die in their first two years, so ARG-007 offers promise the therapeutic can finally turn around the incidence of the life-threatening condition in babies which happens when not enough oxygen flows to the brain before, during or after their deliveries.

Argenica’s latest approval provides a potential award of a Priority Review Voucher, a redeemable asset used to accelerate the review of a marketing application if not sold to another party, a transfer often accounted for in the tens of millions.

Preclinical data has shown the treatment having a significant impact on reducing brain cell death from the condition on an animal model, and Argenica continues work on validating a prospective treatment on newborns.

ARG-007 has already received an Orphan Drug Designation for the condition, a status given to drugs which have demonstrated promise on rare diseases which provides greater FDA guidance and a potential seven years of US market exclusivity.

Argenica Managing Director Dr Liz Dallimore said further validation by the FDA on the promise of ARG-007 was extremely encouraging.

“There are currently no therapeutic drugs available to treat this devastating condition,” Dallimore said.

“This RPDD will provide the company with potential significant upside at the end of a clinical program in HIE to receive a priority review to get the drug on the market quickly, or the option to sell the voucher to a third party.

“We look forward to continuing to progress the development of ARG-007 as a treatment for HIE in newborn infants.”

And while Argenica advances its preclinical status for HIE, stage 2 clinical trials for the therapeutic’s most advanced possible use, treatment of ischaemic stroke, is now getting underway across 10 Australian hospitals.

The trials are slated to provide key data on the safety and preliminary efficacy of ARG-007’s treatment of stroke.

Proof of ability to reduce the volume of braincell death after stroke would position ARG-007 as a leading neuroprotective drug candidate and open the path for wide-spanning phase 3 studies and potential partnerships.

The drug has also been preclinically shown to significantly reduce the cellular uptake of the key proteins related to Parkinson’s disease and braincell damage from traumatic injuries.

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