Argenica Therapeutics produces GMP-grade ARG-007 for prevention of brain tissue death in stroke patients
Argenica says the successful GMP manufacturing trials will enable the company to progress to clinical studies and provide more confidence surrounding manufacturing and safety.
Newly-listed biotech Argenica Therapeutics (ASX: AGN) has confirmed that two of its manufacturing partners have produced scaled-up, GMP-grade batches of its neuroprotective peptide candidate ARG-007 for the prevention of brain tissue death in stroke patients.
Australian peptide producer AusPep was the first to test all aspects of ARG-007 production and confirm the process development and scale-up of the drug to GMP (good manufacturing practice) grade, which is critical to Argenica undertaking safety and toxicology studies before commencing in-human Phase 1 clinical trials.
The scaled-up manufacturing process resulted in a product with a final purity of 99.9%.
Peptide purity can have a fundamental impact on a therapeutic drug’s safety, and any impurities may change the desired efficacy or induce unwanted toxicity.
For a peptide drug to be used in clinical trials, it must achieve a purity level of greater than 98%.
Mitigating risks
Argenica also engaged US-based GMP peptide manufacturer AmbioPharm to conduct similar trials on ARG-007 in an effort to mitigate production risks associated with a single manufacturing partner.
AmbioPharm achieved process development optimisation at a purity of 99.3%, indicating it should be able to produce the drug to GMP quality and grade.
The GMP grade material is now with Argenica’s clinical research organisation partner for use in pre-clinical studies including standard genotoxicology, final pharmacokinetics, safety and toxicology work.
Increased confidence
Argenica chief executive officer Dr Liz Dallimore said AusPep and AmbioPharm’s achievements would allow it to progress towards clinical trials with increased confidence surrounding manufacturing and safety.
“Passing the GMP scale-up manufacturing milestone and process optimisation is incredibly exciting, especially given the very high peptide purities generated,” she said.
“We have de-risked our reliance on a sole manufacturing partner, and achieved a high purity product that we can use in our pre-clinical studies and phase 1 clinical trial.”
Novel therapeutics
Argenica is developing ARG-007 as a novel therapeutic drug to reduce brain tissue death after stroke and improve patient outcomes.
It is a cationic arginine-rich peptide which has been in pre-clinical development for more than six years and shown preclinical evidence of induced neuroprotection in animal models of stroke.
Dr Dallimore said the aim was for the therapeutic to be administered by first responders to protect brain tissue against damage during a stroke, with further potential to enhance recovery once a stroke has taken place.
Argenica debuted on the ASX in June following a $7 million initial public offering.