Argenica Therapeutics (ASX: AGN) has announced results of recent in-life rodent and non-human primate toxicology studies, showing success in determining the maximum tolerated dose of ARG-007, required for the phase one clinical trial ethics approval.
The Perth-based biotechnology company, in a bid to develop novel therapeutics to reduce brain tissue death after stroke, has made a breakthrough in its final Good Laboratory Practice (GLP) toxicology studies.
Argenica Therapeutics chief executive officer Dr Liz Dallimore says the findings are optimal, allowing the company to progress.
“The results of the GLP toxicology data demonstrate that ARG-007 has a good safety margin from the efficacious dose to the maximum tolerated dose,” she said.
“This gives us added confidence that we will be able to achieve ethics approval for the upcoming phase one clinical trial.”
GLP studies highlights strength of ARG-007
The results showed the maximum tolerated dose of ARG-007, Argenica Therapeutic’s lead neuroprotective peptide candidate, is up to 10 times the efficacious dose range identified in animals, also providing a desirable safety margin to establish the safe starting dose in the phase one clinical trial.
GLP studies were also able to determine the onset, degree of severity, and length of time in which a particular dose of a drug demonstrates any toxic effects.
The results collected were mortality and clinical observational data, toxicokinetics, hematology blood clinical chemistry analysis, urinalysis, and necropsy data.
Argenica Therapeutics is hopeful the findings from the studies will be a key inclusion in its submission to the Human Research Ethics Committee for approval of the phase one clinical trial.
This is required by the regulatory bodies to understand the toxicology profile of a new drug before being allowing it to be administered in humans.
Next step for Argenica Therapeutics
Argenica is now going through its final pathology assessments and final safety studies using the determined maximum tolerated dose, to be included in the company’s ethics submission.
The maximum tolerated dose established in these previous studies is significantly higher than intended doses to be used in the phase one clinical trial, which will reduce the chances of an errors occurring during the trial.
The Perth-based company’s aim is to have its therapeutic administered by first responders to protect brain tissue against damage during a stroke. Further potential to enhance recovery once a stroke has taken place is a step closer after the breakthrough results released this week.