Biotech company Argenica Therapeutics Limited (ASX: AGN), which is developing novel therapeutics to reduce brain tissue death after stroke, has completed the production of its neuroprotective peptide candidate ARG-007 in powder form.
The Company is gearing up for its Phase 2 clinical trials, and the final manufacturing of the sterile drug product in vials is scheduled to be completed by the end of this year. The successful manufacturing of the clinical trial batch of ARG-007 guarantees that Argenica will be able to initiate the first patient dosing in the first quarter of CY24.
The Phase 2 trial aims to determine the safety, preliminary efficacy, and pharmacokinetics (i.e. how a body responds to the medicine) of ARG-007 in Acute Ischemic Stroke (AIS) patients. Proving ARG-007 is safe in these patients will pave the way for the Company to progress to a Phase 3 trial and engage with global pharmaceutical companies.
Managing Director Dr Liz Dallimore stated, “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.”
Auspep Clinical Peptides, a Melbourne-based peptide manufacturer, has finished producing ARG-007 in powder form. The powder has been sent to CordenPharma, Argenica’s European contract manufacturer, where it will be filled and finished as sterilised vials of the ARG-007 drug product solution. This process adheres to Good Manufacturing Practices (GMP) and prepares the solution for patient dosing in the Phase 2 clinical trial.
CordenPharma has ramped up its manufacturing processes to produce ARG-007 under GMP conditions, creating the final sterile vials for the Phase 2 trial. It has already manufactured the saline placebo vials. Testing of the vials is set to finish in early Q1 2024.
After testing, ARG-007 and placebo vials will be sent to Central Pharmacy Logistics (CPL) in Australia, where they will be logged and distributed to various hospital sites for patient dosing in Q1 2024.
Since obtaining ethics approval in September 2023, Argenica’s clinical trial team has been collaborating with several hospitals in Australia to designate them as sites for the Phase 2 clinical trial. Even though the trial has ethical approval, each hospital involved in the Phase 2 trial is responsible for ensuring the scientific quality, ethical acceptability, and safety of the conducted clinical trial within its premises. So, Argenica has been actively engaging with each hospital through a site-specific assessment (SSA) process.
Final 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.
Royal Melbourne, Princess Alexandra, and John Hunter hospitals have submitted their SSAs to their respective Research Governance Offices. Royal Melbourne Hospital has secured the approval, initiating patient recruitment and dosing once the ARG-007 and placebo vials are received.
In December, Sir Charles Gardiner Hospital (Perth), Royal Adelaide Hospital (Adelaide), and Liverpool Hospital (Sydney) are expected to submit their SSA research governance documentation. The additional four hospitals will complete their SSA research governance in January 2024.
Upon approval of SSAs by the Research Governance Offices at each hospital, patient dosing can start as per Phase 2 clinical trial protocol.
Finally, the Company has set up an Independent Data Safety Monitoring Board (DSMB). During the trial, there will be five scheduled data review meetings with the DSMB. These meetings aim to assess safety data and recommend potential protocol changes. The outcomes will be shared publicly.
As Argenica goes full steam ahead with its Phase 2 trials, the medical industry can look forward to major advances in neurological therapeutics.
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