Argenica Therapeutics receives preliminary US patent approval for lead drug to treat stroke patients

Argenica Therapeutics ASX AGN patent United States US stroke TBI HIE ARG-007
Argenica Therapeutics anticipates the formal patent will be granted for its lead drug ARG-007 "within months".

The United States Patent and Trademark Office has issued a preliminary patent approval for Argenica Therapeutics’ (ASX: AGN) lead drug ARG-007 as a therapeutic treatment for patients of stroke, traumatic brain injury (TBI) and hypoxic ischaemic encephalopathy (HIE).

The “notice of allowance” confirms the company’s Neuroprotective Peptides patent application has been allowed for issuance and Argenica anticipates formal granting of the patent to occur within months.

ARG-007 is a neuroprotective therapeutic drug which has been shown to reduce brain cell death following stroke, TBI and HIE in animal models.

It is in the process of being verified for its safety and toxicity before the company commences phase 1 clinical trials in humans early next year.

Argenica hopes the drug will be used by first responders to protect brain tissue against damage during a stroke, with further potential to enhance recovery once a stroke has taken place.

Other neurological conditions

The patent application also covers use of the drug in other neurological conditions such as Alzheimer’s disease, Huntington’s disease, multiple sclerosis, Parkinson’s disease, motor neuron disease, neuropathic pain, spinal cord injury and epilepsy.

It provides Argenica with confidence that ARG-007 can be commercialised in broader applications within the US should the company generate the efficacy data required to progress its development for these conditions.

Important step

Argenica chief executive officer Dr Liz Dallimore said the notice of allowance was an important step in the drug’s development process.

“Stroke, TBI and HIE are conditions with huge unmet medical needs in the US and represent large addressable markets that we will be looking to target,” she said.

“The granting of this patent will strengthen our ability to enter into commercial negotiations with US pharmaceutical companies in the future.”

Stroke statistics

Each year in the US, approximately 795,000 people suffer a stroke; 1.5 million people sustain a TBI; and approximately four in every 1,000 live term births and up to 60% of pre-term infants suffer HIE.

Argenica already has granted patents for ARG-007 in the large addressable markets of the European Union (validated in 11 key countries), Japan and China.

The patents are wholly-owned by Argenica and its IP (intellectual property) assignment is free of royalties or other encumbrances.

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