Argenica Therapeutics has secured non-dilutive cash funding from the Stan Perron Charitable Foundation (SPCF) via the Perron Institute for Neurological and Translational Sciences to progress preclinical studies into the efficacy of its ARG-007 drug in neonatal Hypoxic Ischaemic Encephalopathy (HIE).

HIE may happen when not enough oxygen or blood goes to a baby’s brain, causing the brain to be injured.

Previous studies assessing the efficacy of ARG-007 in both a preterm and term rat model of neonatal HIE showed a significant reduction in the amount of brain cell death following administration of the drug.

In the term model, a 300 nmol/kg dose reduced neuronal cell death by 86% compared with saline controls 24 hours post administration.

The company says this funding will be used to complete the preclinical animal studies required to progress ARG-007 into clinical trials in newborn infants.

Progressing to preclinical animal studies

To move into human clinical trials in newborn infants, preclinical efficacy studies in rats and larger animal models, plus juvenile toxicology studies in rats, are required to be completed.

The total cost of all preclinical animal efficacy and toxicology studies is approximately AUD3.6million. The grant will cover the costs of the preclinical animal efficacy studies, while Argenica will cover the costs of the juvenile toxicology study which is in the order of AUD1.1m

“The support of the Stan Perron Charitable Foundation for this important research led by Dr Edwards is extremely generous,” MD Dr Liz Dallimore said.

“The Foundation is an incredible organisation allowing Western Australian research into the health and wellbeing of children flourish.

“We are optimistic about the therapeutic potential of ARG-007 in HIE and look forward to working with Dr Edwards and his collaborators to progress these critical studies.”

Commercialisation rights remain with Argenica

Whilst Argenica will not directly receive the funds, ownership of all newly generated intellectual property related to ARG-007 created through the project activities and commercialisation rights of the drug as a treatment for HIE will remain solely with the company.

Argenica will now work with the Perron Institute and the SPCF to finalise the grant agreement.

In parallel, the company is also working with global contract research organisation Labcorp Drug Development’s paediatric regulatory team to develop a regulatory and clinical trial strategy for ARG-007 in HIE in newborns.

Labcorp has extensive experience in planning and running global paediatric clinical trials, as well as obtaining regulatory investigational new drug applications, and orphan drug designation from the Food and Drug Administration for therapies targeting rare paediatric therapies.




This article was developed in collaboration with Argenica Therapeutics, a Stockhead advertiser at the time of publishing.


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