Argenica Therapeutics (ASX:AGN) establishes clinical advisory panel to support Phase 2b stroke trial

Argenica Therapeutics (ASX:AGN) has established a new Clinical Advisory Committee to assist with the advancement of its planned Phase 2b clinical trial of ARG-007 in acute ischaemic stroke, with the group bringing together expertise specific to stroke as the company progresses into later stage clinical trial development.

The company said the committee will support optimisation of trial design, including endpoints, patient selection and dosing strategy.

Highlights

• Argenica has established a Clinical Advisory Committee to assist with advancement of its Phase 2b clinical trial of ARG-007 in acute ischaemic stroke.
• The committee brings expertise across stroke neurology, neurointervention, neuroimaging, neuroprotectant drug development and clinical trial design.
• The committee will support optimisation of trial design, including endpoints, patient selection and dosing strategy.
• Members include Professor Geoffrey Donnan, Dr Tim Phillips, Professor Jeffrey Saver, Dr Michael Devlin, Dr Taylor Kimberly and consumer representative Mr Tony Rolfe.
• Argenica non-executive director Dr Mark Etherton will support the committee.

Professor Geoffrey Donnan, Professor of Neurology at University of Melbourne, co-chair of the Australian Stroke Alliance and former president of the World Stroke Organization, was appointed to the committee for his experience in stroke research and large-scale clinical trials, including imaging-based approaches used to guide patient selection.

Dr Tim Phillips, a consultant interventional neuroradiologist at Sir Charles Gairdner Hospital, Fiona Stanley Hospital and Royal Perth Hospital, leads what the company described as Australia’s highest-volume interventional neuroradiology service and is principal investigator on 11 currently active clinical trials.

Professor Jeffrey Saver, director of the UCLA Stroke Center, was also cited for his work in acute stroke treatment and major ischaemic stroke clinical trials.

The committee also includes Dr Michael Devlin from Princess Alexandra Hospital, who has principal investigator experience in the company’s Phase 2 trial and across multiple imaging-selected stroke trials involving large vessel occlusion.

Dr Taylor Kimberly, Chief of Neurocritical Care at Mass General Brigham and Professor of Neurology at Harvard Medical School, brings expertise in stroke imaging and biomarker development.

Mr Tony Rolfe joins as consumer representative, bringing more than 40 years of experience across Australian health policy and research systems, including senior roles at the National Health and Medical Research Council.

The company said he also brings lived experience of stroke and leadership within the Stroke Foundation Consumer Council.

Argenica non-executive director Dr Mark Etherton will support the committee. He is a former director of the Massachusetts General Hospital Acute Stroke Service and senior medical director at Takeda Pharmaceuticals.

Argenica Managing director Dr Liz Dallimore said the appointments were an important step in advancing ARG-007 into Phase 2b.

“The appointment of this Clinical Advisory Committee represents an important step in advancing ARG-007 into a Phase 2b clinical trial. The Committee brings deep expertise in moderate-to-severe stroke, imaging-based patient selection and late-stage clinical development, which will be critical in optimising trial design and execution. We are focused on maximising the probability of success as we progress ARG-007 towards the next stage of development.”

Argenica said ARG-007 is designed to protect vulnerable brain tissue by reducing cell death and limiting secondary damage after an ischaemic event.

The company said the therapy is being developed to improve outcomes for patients following stroke and other acute neurological injuries, with ARG-007 positioned as Argenica’s lead drug candidate within its broader clinical development strategy.

The company said it remains focused on advancing novel neuroprotective treatments as it progresses ARG-007 toward the next stage of development.