Argenica Therapeutics (ASX: AGN) is readying for phase 1 clinical trials of its stroke drug ARG-007, with pre-clinical study results anticipated throughout the current March quarter.
The company anticipates preliminary study activities, along with ethics submission preparation, and clinical trial and site management set up will be finished by the end of March.
This paves the way for the phase 1 clinical trial to begin recruiting immediately after ethics approval has been secured.
Argenica has developed ARG-007, which is a neuroprotective peptide, to treat people with stroke, traumatic brain injury (TBI) and hypoxic ischaemic encephalopathy (HIE).
In stroke victims, Argenica says ARG-007 can be administered to reduce brain tissue death and improve patient outcomes. It has been designed for first responders to administer.
The drug has been successful in pre-clinical stroke models.
December quarter milestones
During the December quarter, Argenica hit numerous milestones in advancing towards its upcoming clinical trials.
The focus during the period was final pharmacokinetic and safety and toxicology studies to ensure effective and safe dosage of ARG-007 in clinical research.
Argenica has engaged drug development consultants Beyond Drug Development and Ground Zero Pharmaceutics to provide input and advance on the final pre-clinical data package to ensure adherence to US Food and Drug Administration and the Human Research Ethics Committee.
While preparing for the clinical trial in stroke victims, Argenica has also progressed pre-clinical work on using ARG-007 in HIE patients.
HIE occurs when the brain doesn’t receive enough oxygen or blood flow for a period of time and is one of the most serious birth complications.
During the December quarter, Argenica revealed positive results using ARG-007 in a late pre-term animal model of HIE.
In the animal model, ARG-007 was shown to reduce the volume of brain tissue death by 50% compared to groups which only received saline. And compared to the current standard of care, which is hypothermia, ARG-007 reduced the volume of brain tissue death by 40%.
Earlier this month, the company appointed Dr Meghan Thomas as head of clinical development to lead all clinical programs.
In readiness for commercialisation, Argenica obtained patent protection for ARG-007 in the US – collaring one of the world’s largest healthcare markets.
Argenica now has patents for ARG-007 in the EU, Japan, China and the US.
Closing out the December quarter, Argenica had $5.3 million in cash reserves, with net cash operating outflows for the period of $558,000.