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Argenica Therapeutics moves closer to phase 1 in-human trials of ARG-007 for stroke

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By Imelda Cotton - 
Argenica Therapeutics ASX AGN pre-clinical results stroke drug ARG-007 HIE hypoxic-ischaemic encephalopathy brain tissue

Argenica Therapeutics says the positive results indicate ARG-007’S wider potential beyond stroke.

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Perth-based biotech company Argenica Therapeutics (ASX: AGN) has completed the final pharmacokinetic (PK) study into the effects of lead candidate ARG-007 on the bodily functions of stroke patients.

The rodent-based study was essential in determining how the drug is absorbed, distributed, metabolised and excreted by the body and helped establish appropriate dosing regimes for a phase 1 in-human clinical trial.

Data generated showed favourable PK profiles in the dose range of 0.05 milligrams per kilogram to 5mg/kg of ARG-007 and included an efficacious dose range of approximately 1mg/kg to 3mg/kg (in rodents).

The drug reached maximum concentration in the blood in rapid time, indicating a fast onset of therapeutic effect.

Pilot study

The results confirm ARG-007’s PK profile as determined by a pilot pre-clinical PK study in mid-2021.

It further supports previous measured data from a radiolabelled positron emission tomography (PET) imaging study showing ARG-007 is rapidly taken up by the kidneys (the standard route of peptide clearance from the body).

In addition to measured PK data, no adverse effects were observed in the animals in each arm of the study.

The data indicates that ARG-007 should be safe and well-tolerated in humans at pharmacodynamically relevant doses.

Data package

An understanding of the PK of investigational drugs is essential for establishing appropriate dosing regimens and is an important element of the data package required to initiate the clinical development of ARG-007.

Chief executive officer Dr Liz Dallimore said the data would be used to more effectively plan the phase 1 in-human clinical trials.

“The completion of this pharmacokinetics study is the final step required to finalise our ethics submission, allowing us to move closer to initiating our phase 1 clinical trial,” she said.

“Achieving favourable PK profiles in this animal study complements the positive data we have received from our safety and toxicology studies.”

Phase 1 trial

The phase 1 trial will aim to improve Argenica’s understanding of how ARG-007 affects the body, and allow it to evaluate the drug’s safety when administered in humans.

It will also focus on determining the ideal safe dosage and identifying any possible adverse reactions before the company moves onto a more comprehensive phase 2 trial, where ARG-007 will be administered to stroke patients.