After extensive research and pre-clinical studies, Argenica Therapeutics (ASX: AGN) is gearing up to begin the phase 1 clinical trial for its stroke treatment drug ARG-007 in the first quarter of next year.
The company revealed a road map for the trial to begin, with final pharmacokinetic and safety toxicology studies in animals expected to be complete either late this year or early next year.
These final animal studies are essential for establishing dosing regimes, and characterising the safety profile of ARG-007 prior to in-human trials beginning.
Linear Clinical Research partnership
In readiness for the trial, Argenica engaged Perth-based clinical research facility Linear Clinical Research late last month.
Linear has a purpose-built facility that operates out of the QEII Medical Centre in Nedlands and a database of around 29,000 healthy volunteers which will be used as a recruitment pool for the trial.
Argenica has engaged Linear to undertake preliminary work for the trial including protocol familiarisation, clinical site management setup, preparation of ethics submission, booking clinical beds for the length of the trial, and establishing the clinical study monitoring.
Phase 1 clinical trial
The trial will involve four cohorts with each comprising eight healthy people.
Each cohort will receive a different dose of ARG-007. Within each cohort, six will receive the specified dose of ARG-007, while two subjects will have a placebo.
Argenica expects the phase 1 clinical trial will take six months to complete and provide it with data surrounding the safety, tolerability, and pharmacokinetics of ARG-007 when it is administered in healthy human patients.
The trial will also evaluate the safety of the dose administered and monitor any adverse reactions and general tolerance.
Progressing to phase 2 clinical study
Data from phase 1 in-human research will underpin the roadmap for the phase 2 trial where ARG-007 will be administered to stroke patients.
The company’s ultimate goal with ARG-007 is for the drug to be administered immediately to reduce penumbral cell death.
This would improve patient outcomes and reduce recovery times.
Argenica noted phase 1 clinical data would also be used to potentially accelerate clinical development of ARG-007 for treating other types of brain injury, including perinatal hypoxic ischemic encephalopathy, traumatic brain injury and concussion, and surgically induced stroke.
According to Argenica, the current standard of care in stroke patients caters to the treatment and diagnosis of stroke, not protection of brain cells.
It is estimated the brain ages about 3.6-years for every hour that appropriate stroke treatment is delayed – meaning timely diagnosis and treatment is critical to a patient’s outcome.
Analysts have forecast the stroke treatment costs worldwide will reach $183 billion by 2030.
ARG-007 is a cationic arginine rich peptide, which has been designed to protect brain tissue against damage during stroke, and enhancing recovery chances once one has occurred.
Argenica’s vision is to develop and commercialise therapeutics such as ARG-007 that can help stroke patients at the earliest possible stage to minimise injury and improve outcomes.