Argenica Therapeutics (ASX:AGN) breakthrough in stroke treatment shows promise in phase 2 trial

Argenica Therapeutics (ASX:AGN) is making significant strides in its mission to develop life-changing treatments for stroke and other brain injuries.

As part of its Phase 2 clinical trial for ARG-007, a groundbreaking neuroprotective peptide designed to minimise brain damage post-stroke, the company recently passed a crucial safety milestone.

An independent Data Safety Monitoring Board (DSMB) has recommended that the trial proceed as planned, with no adjustments to the protocol, following a comprehensive review of safety data from the first half of participants.

This endorsement not only underscores the strong safety profile of ARG-007 but also accelerates Argenica’s goal of offering new hope to stroke patients.

Highlights:

• Positive Safety Review: Data Safety Monitoring Board (DSMB) approves continuation of Phase 2 trial.
• Progress Milestone: 63% of patient dosing completed; all trial sites activated.
• Expected Completion: Full recruitment anticipated by Q2 2025.

Argenica Therapeutics is pushing forward in its Phase 2 clinical trial for ARG-007, a neuroprotective peptide aimed at reducing brain damage after strokes.

With 63% of patients now dosed, the trial has received a positive safety recommendation from the independent DSMB.

“This is a significant milestone for the Company,” stated Dr Liz Dallimore, Managing Director of Argenica. “With a green light from the DSMB to continue the trial unchanged, we are delivering on our stated objectives.”

ARG-007 targets acute ischaemic stroke patients to improve brain recovery, a vital advancement in stroke treatment.

The DSMB’s recommendation to proceed without protocol modifications reflects confidence in ARG-007’s safety profile. Of the 46 patients reviewed, there were no serious adverse events; only one patient reported mild issues, including bradycardia and hypotension, both of which resolved swiftly.

The trial’s design includes both stroke patients who receive standard clot-busting medication, tissue plasminogen activator (tPA), and those who do not, allowing researchers to understand the interplay between ARG-007 and tPA.

This nuanced approach could lead to breakthrough findings, paving the way for ARG-007 as a supplementary stroke therapy.

Argenica’s progress, coupled with a green light from the DSMB, strengthens its commitment to revolutionising stroke care.

The company expects to conclude dosing by Q2 2025, with final data anticipated shortly thereafter. With all 10 trial sites now activated and a steady pace of recruitment, the future looks promising for this innovative Australian biotech.

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