Biotechnology company Argenica Therapeutics (ASX: AGN) has engaged Perth-based company Linear Clinical Research to initiate preliminary work required for a phase 1 trial into the safety and tolerability of stroke-treatment drug ARG-007 on healthy human subjects.
Linear’s work will comprise study start-up activities 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.
The company has a purpose-built facility at QEII Medical Centre and a database of around 29,000 healthy volunteers which will be used as a recruitment pool for the trial.
Since 2010, it has conducted over 170 studies across 19 therapeutic areas and has extensive experience in phase 1 trials, including adaptive healthy volunteer and patient protocol designs.
Argenica chief executive officer Dr Liz Dallimore said Linear was the ideal partner to help progress the new trial.
“Linear has fantastic credentials in conducting clinical trials for organisations across the globe [and] can offer us a full-service solution incorporating trial design, patient recruitment and final data analysis,” she said.
“We will now move forward with the preliminary work required to set up the trial, moving towards project delivery timelines to ensure quality execution of our phase 1 trial.”
Dr Dallimore said it is hoped ARG-007 will be eventually 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.
Safety and tolerability
Argenica’s phase 1 clinical trial will be conducted in healthy volunteers to assess the safety, tolerability and pharmacokinetics of single ascending doses of ARG-007.
It will be run as a double-blind, randomised, placebo-controlled, sequential-groups study across a total of 32 participants (enrolled in four groups of eight).
On the first day of the trial, each participant will receive either a dose of ARG-007 or a placebo, with safety pathology samples and data collected at multiple points over the following eight days.
The trial will help Argenica determine if ARG-007 is safe and well-tolerated when administered in healthy human subjects.
Data collected will provide the foundation for a phase 2 trial, which will see ARG-007 administered to stroke patients.
Argenica said it would release further details on the phase 1 trial including an estimated timing roadmap, primary endpoints, information on patient cohorts and dosing amounts as the details are confirmed with Linear.