Argenica (ASX:AGN) granted Orphan Drug Designation by the FDA

Argenica (ASX:AGN) granted Orphan Drug Designation by the FDA

November 15, 2023 Off By Tom Duggan

Argenica Therapeutics‘ novel treatment ARG-007 has been granted Orphan Drug Designation by the Food and Drug Administration for treatment of Hypoxic Ischaemic Encephalopathy.

The Orphan designation is given to drugs or biological products which can prevent, diagnose, or treat rare diseases or conditions and opens up not only tax credits for clinical trials and user fee exemptions, but potentially seven years of market exclusivity.

Argenica Managing Director Dr Liz Dallimore said the granted designation was a key pillar of the company’s commercialisation strategy for ARG-007.

“The potential for extensive market exclusivity following approval of ARG-007 is an extremely compelling commercial driver for the Company,” Dr Dallimore said.

“We look forward to continuing to progress the development of ARG-007 as a treatment for HIE in newborn infants, in which there are currently no therapeutic drugs available to treat this devastating condition.”

Treating HIE

Preclinical data has shown ARG-007 significantly reducing brain cell death in animal models of the condition, and Argenica is continuing work to complete all the required studies to progress to clinical trials.

The condition occurs when the brain does not receive enough oxygen or blood flow, possibly occurring at any time before labour through to immediately after delivery.

The initial injury is followed by progressive brain cell death, and while some children will only display minor effects, it can cause severe permanent disabilities.


Initially developed as a treatment to reduce brain tissue death after stroke, ARG-007 has since shown effectiveness on a wide range of neurodegenerative diseases.

Alongside up to 70 per cent reduction in brain tissue death in stroke victims, it has been shown to significantly reduce the cellular uptake of key proteins related to Parkinson’s and Alzheimer’s Diseases and braincell damage caused by traumatic injuries.

Argenica is now progressing towards Phase 2 clinical trials for ischaemic stroke patients as it continues to generate preclinical data as a potential wide-ranging treatment of neurological disorders.

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