A neuroprotective drug candidate being trialled in WA for ischaemic stroke may also be beneficial for treating Alzheimer’s.
The novel therapeutic ARG-007 has been developed by researchers from The Perron Institute and UWA in conjunction with WA-based biotechnology company Argenica Therapeutics, and is currently at the clinical trial stage as an early intervention treatment to reduce brain damage in stroke.
Argenica has recently completed a Phase 1 clinical trial in healthy human volunteers to assess the safety and tolerability of ARG-007, and the safety report, provided by Linear Clinical Research (Linear) who ran the trial, confirmed that overall, ARG-007 was safe and well tolerated at all doses tested.
Argenica is now progressing towards a Phase 2 clinical trial in ischaemic stroke patients, as well as continuing to generate preclinical data in other neurological conditions, including in TBI, HIE and Alzheimer’s Disease.
Dr Liz Dallimore, Argenica’s Managing Director said preclinical research indicated that ARG-007 may be effective in treating people with Alzheimer’s by inhibiting what is thought to be one of the main causes, abnormal build-up of proteins in and around brain cells.
“Initial data on ARG-007’s ability to significantly reduce the aggregation of one of these proteins, Amyloid-Beta, in an in vitro model of Alzheimer’s Disease is exciting,” she said.
“We are delighted to receive this data package from Linear confirming the safety and tolerability of ARG-007.
“Receiving the unblinded data and comparing the treatment groups with the placebo groups in our Phase 1 clinical trial shows that we are not seeing any clinically significant adverse events related to administration of ARG-007.”
Efficacy was demonstrated in many preclinical models of stroke and other brain injuries, and according to Argenica’s ASX announcement on 6 March 2023, the interim safety report confirmed that there were no clinically significant adverse events seen in participants dosed with ARG-007 at any of the dosage levels tested.
The only adverse events observed during the trial were mild to moderate and were observed in both the ARG-007 treatment groups (54.2%) and the placebo group, with a greater percentage among the placebos (62.5%).
From a total of 31 treatment emergent adverse events or TEAEs in all participants, only 10 of these were considered ‘related’ to the administration of ARG-007, with the two most common TEAEs being headaches and dermatitis.
No clinically significant findings were reported in laboratory parameters, vital signs, physical examination and heart monitoring, and immune dysregulation biomarkers confirmed that ARG-007 did not cause an immune reaction in healthy participants, with preliminary distribution data indicating that the drug is excreted by the kidneys.
“We can now work with Linear to finalise the trial report in preparation for our ethics submission to commence our Phase 2 trial in ischaemic stroke,” Dr Dallimore said.
“Pleasingly, the data generated from the safety report, will also be able to be used for a number of other phase II trials in additional indications.
“Philanthropic funding via the Perron Institute will enable the preclinical studies on the efficacy of the ARG-007 drug to continue.”
The total of $350,000 includes $250,000 from the McCusker Charitable Foundation, which has a long history of supporting Alzheimer’s research in WA, with an additional $100,000 funding from Mr Jim Litis, a long-standing supporter of the Perron Institute.
“We sincerely thank these donors, the McCusker Charitable Foundation and Mr Litis, for this generous funding to support ongoing research on ARG-007 in collaboration with the Perron Institute,” Dr Dallimore said.
Professor Bruno Meloni, head of the Perron Institute’s Stroke Laboratory Research and Argenica’s Chief Scientific Officer, will oversee the Alzheimer’s disease preclinical study, which is due to commence in March with results expected in late 2023.
“After many years of hard work developing our neuroprotective drug for stroke, it’s exciting to see its potential application as a treatment for Alzheimer’s disease moving forward,” he said.
Argenica’s stock increased 5% on the ASX: AGN with news of the results.