Argenica Therapeutics (ASX: $AGN) Phase 2 stroke clinical trial update

Argenica Therapeutics Limited (ASX: $AGN) has completed the manufacturing of the ARG-007 drug substance required for the Phase 2 clinical trial, with the finalised sterile drug product manufacturing to be completed by the end of Q4 CY2023. The company is on track to commence patient dosing in Q1 CY2024. Additionally, approvals for hospital clinical trial sites remain on track, with one hospital ready to commence patient dosing, and several others in the final stages of approval. Argenica has also established an independent Data Safety Monitoring Board (DSMB) for the Phase 2 trial.

Executive Commentary on Phase 2 Stroke Clinical Trial Progress

Proving the scale-up manufacturing of the clinical grade ARG-007 drug product is a significant milestone for the Company, and we are delighted manufacturing timelines remain on track. Further, we are pleased with the progress of research governance at each hospital, there is a lot of work going on behind the scenes in the Company to prepare for our upcoming Phase 2 trial. We look forward to keeping shareholders updated as further milestones are achieved.

Summary of Argenica Therapeutics Phase 2 Stroke Clinical Trial Update

Argenica Therapeutics (ASX: $AGN) has made significant progress in the Phase 2 stroke clinical trial, with the completion of manufacturing of the ARG-007 drug substance and the establishment of hospital clinical trial sites. The company is on track to commence patient dosing in Q1 CY2024. The Phase 2 trial aims to provide data on the safety and preliminary efficacy of ARG-007 in acute ischaemic stroke patients, paving the way for a pivotal Phase 3 trial and potential partnering with pharmaceutical companies. Additionally, the trial is designed to generate preliminary data on the ability of ARG-007 to reduce brain tissue death following stroke and mechanical removal of brain clot. Argenica's ambitions include progressing to a pivotal Phase 3 trial and engaging with global pharmaceutical companies, positioning the company at the forefront of neuroprotective clinical validation.