US FDA grants Argenica Therapeutics' ARG-007 orphan drug designation

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The US FDA has granted Argenica Therapeutics' (ASX:AGN) ARG-007 Orphan Drug Designation (ODD) for the treatment of Hypoxic Ischaemic Encephalopathy (HIE).

Argenica recently announced further encouraging preclinical data on the potential of ARG007 in reducing brain injury following HIE. The data showed that ARG-007 significantly reduces brain cell death in animal models of HIE.

HIE occurs when the brain does not receive enough oxygen or blood flow for a period of time. It may occur at any time prior to labour, during labour and delivery, or immediately following delivery. The initial injury caused by a loss or reduction of oxygen supply is followed by progressive brain cell death due to excitotoxicity, oxidative stress, and inflammation.

Dr Liz Dallimore, Argenica’s managing director, said, “The granting of Orphan Drug Designation for ARG-007 in HIE forms a key pillar of Argenica’s commercialisation strategy. The potential for extensive market exclusivity following approval of ARG-007 is an extremely compelling commercial driver for the Company. 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.”