Join our daily newsletter At The Bell to receive exclusive market insights
- Newly listed biotech Argenica Therapeutics (AGN) confirms two of its manufacturing partners have successfully scaled-up the manufacturing of ARG-007
- ARG-007 is the company’s lead drug and aims to reduce brain tissue death after a stroke
- Argenica’s Australian based peptide manufacturer, AusPep, has tested the drug production, which saw achieved a purity profile of 99.9 per cent, well above the required level for clinical trial
- The company also engaged US-based GMP peptide manufacturer, AmbioPharm, to conduct similar trials on ARG-007
- On the market this afternoon, Argenica is up 2.94 per cent and is trading at 35 cents per share
Argenica Therapeutics (AGN) has confirmed two of its manufacturing partners have successfully scaled-up the manufacturing of ARG-007.
ARG-007 is the company’s lead drug and aims to reduce brain tissue death after a stroke.
Notably, the manufacturing of the drug will be up to the good manufacturing practice (GMP) standards.
GMP is a globally-recognised standard for ensuring rigorous and continually monitored processes in drug manufacturing to minimise risks and ensure drugs are safe and effective when administered to patients.
Argenica’s Australian based peptide manufacturer, AusPep, has tested all aspects of ARG-007 production and confirmed the successful process development and scale up of GMP grade ARG-007.
The scaled up GMP grade achieved a purity profile of 99.9 per cent, well above
the required level for clinical trial.
Achieving GMP manufacturing of ARG-007 was needed for Argenica to
undertake safety and toxicology studies in pre-clinical experiments before commencing its inhuman phase one clinical trials.
The company also engaged US-based GMP peptide manufacturer, AmbioPharm, to conduct similar trials on ARG-007, who also achieved process development optimisation of the manufacturing of ARG-007 at a purity of 99.3 per cent.
Commenting on the manufacturing milestone was Chief Executive Officer Liz Dallimore.
“Passing the GMP scale up manufacturing milestone and process optimisation is incredibly exciting for Argenica, especially at the very high peptide purities generated,” Dr Dallimore said.
“We have de-risked our reliance on a sole manufacturing partner and achieved high purity product from both manufacturers. We now have a high purity GMP grade product that we will use in both our pre-clinical studies and phase one clinical trial.”
On the market this afternoon, Argenica was up 2.94 per cent and is trading at 35 cents per share at 3:30 pm AEST.
