Argenica (ASX:AGN) completes clinical manufacturing

Argenica Therapeutics has completed upscaled manufacturing and release testing of GMP-grade ARG-007 therapeutic, with the drug for people with brain injury and neurodegenerative conditions now ready for testing in acute ischaemic stroke patients.

The Phase 2 trials are to debut next month and are slated to provide key data on the safety and preliminary efficacy of ARG-007, paving the way for a pivotal Phase 3 study and potential partnerships.

With a dearth of drugs of its kind on market, evidence of ARG-007’s ability to reduce the total volume of brain cell death by preserving neurons would position the therapeutic as a leading neuroprotective drug candidate.

Potential applications of ARG-007 for treating neurological disorders are wide-ranging but good pre-clinical and Phase 2 data would be a leap forward proving its conceptual purpose in efficacy against stroke.

Argenica Managing Director Dr Liz Dallimore said the company achieving successful scale-up for manufacturing at current good manufacturing practice standard was a huge milestone.

“We’re also delighted to bring on the Gold Coast and Royal Brisbane & Women’s hospitals into the trial. Both will be fantastic additions to the trial, with both having exceptional experience in stroke care and clinical trials,” Dr Dallimore said.

“We look forward to working with such highly credentialled and committed professionals at all of our trial sites in the delivery of this Phase 2 trial.”

The Gold Coast and Royal Brisbane & Women’s hospitals will also be included in the trial list, now standing as 10 sites which see high volumes of stroke patients and host comprehensive stroke units with highly specialised resources and personnel.

The treatment has already been granted orphan drug designation by the US Food and Drug Administration for treatment of hypoxic ischaemic encephalopathy, opening up tax credits and potentially seven years of market exclusivity.

Argenica has also shown the preclinical ability to reduce cellular uptake of the ‘Parkinson’s protein’ aggregates by 84 per cent and to significantly reduce braincell damage caused by traumatic brain injuries.

The company’s initiation visits will begin this month and enable the sites to start recruiting and dosing patients into the trial, with first dosing on track to begin next month for the Perth-based biotech’s landmark clinical trials.

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