Argenica on track to commence patient dosing for Phase 2 stroke clinical trial in Q1

Argenica Therapeutics wraps up manufacturing of ARG-007 drug for Phase 2 clinical trial in acute ischaemic stroke
Patient dosing for trial expected to commence in Q1 CY2024
Data on safety and efficacy will pave the way for Phase 3 trial

Special Report: Argenica Therapeutics is progressing its Phase 2 clinical trial in acute ischaemic stroke (AIS) patients, with the manufacturing of its ARG-007 drug substance now complete.

The Phase 2 trial will be a multi-centre, double-blind, randomised, placebo-controlled, parallel-group, single-dose study to determine the safety, preliminary efficacy and pharmacokinetics of ARG-007 in AIS patients.

Proving the drug is safe is expected to pave the way for Argenica Therapeutics (ASX:AGN) to progress to a pivotal Phase 3 trial and engage with global pharmaceutical companies.

The trial will recruit only patients with a diagnosed large vessel occlusion (LVO) stroke that are eligible for endovascular thrombectomy (mechanical removal of a clot in the brain).

LVO strokes account for close to 40% of all acute ischaemic strokes and are responsible for 60% of post-stroke dependency and 90% of mortalities after stroke – and are therefore considered the most devastating type of stroke.

Generating preliminary data on the ability of ARG-007 to reduce brain tissue death following stroke and thrombectomy will be a significant de-risking milestone for the company.

Patient dosing in Q1 CY24

The finalised sterile drug product manufacturing is now expected to be completed by the end of Q4 2023 ahead of patient dosing in Q1 2024.

“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,” managing director Dr Liz Dallimore said.

“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.”

The trial will be conducted in up to 10 hospitals across Australia that have dedicated stroke care units capable of performing endovascular thrombectomy.

Final approvals for hospital clinical trial sites remains on-track, with one hospital ready to commence patient dosing, and several others in the final stages of approval.

Data will pave the way for Phase 3

The Phase 2 trial will 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.

As part of the trial, AGN has established an independent Data Safety Monitoring Board (DSMB) comprising several independent neurologists and a biostatistician, who will be responsible for reviewing the safety data as the trial progresses.

The purpose of the DSMB is to monitor the rates of adverse events (AEs), endpoints, and study progress in the Phase 2 trial.

In addition, the DSMB will provide recommendations regarding the continuation, modification, or termination of the study to AGN.

This article was developed in collaboration with Argenica Therapeutics, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.