Argenica (ASX:AGN) backed in for Phase 2
June 2, 2023Argenica Therapeutics’ investor backing has opened the way for a Phase 2 trial of its novel therapeutics for ischaemic stroke patients after a successful $4 million placement.
Phase 1 successfully trialled ARG-007, a treatment developed by leading UWA researchers and the Perron Institute to reduce brain tissue death after stroke, with all doses judged as safe and well-tolerated.
Planning for the second phase is already well advanced; suppliers are selected, contracts are advanced, and early manufacturing is underway, with long lead time items ordered and paid for.
It is slated as a blinded and randomised placebo-controlled study to determine the safety and effectiveness of a single dose. It is expected to be conducted across multiple hospitals across Australia for ischaemic stroke patients.
“We are delighted to have secured the support again of many of our large and existing shareholders, as well as new institutional investors who recognise the importance of advancing ARG-007 into a Phase 2 trial in ischaemic stroke patients,” Argenica Managing Director Dr Liz Dallimore said.
“We look forward to providing further updates as we advance the Phase 2 trial, along with providing updates on the results of our preclinical work in other neurological indications.”
The Perth-based company has also secured over $4 million in grants and philanthropic funding to support work on other neurological issues, including hypoxic ischaemic encephalopathy, traumatic brain injury, and Alzheimer’s Disease.
A national health issue
It is estimated there are over 100 stroke events in Australia every day, and it presents a significant health issue for older age groups, with more than two-thirds of sufferers aged 65 or over.
Given its standing as a national health issue, Argenica anticipates additional cash flows from research and development tax rebates, with the government providing up to 43.5 per cent in refunds for eligible activities.
Forward plan
The company aims for an ethics application later in the year, and a pre-IND meeting request will be lodged with the Food and Drug Administration imminently to ensure the organisation is satisfied with the design of its Phase 2 trial.
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