Argenica Therapeutics, which is developing new therapies for reducing brain tissue death after stroke, has announced the dosing of the first subjects in the third cohort of its Phase I clinical trial of ARG-007.
The third cohort subjects will receive an increased dose of the therapy compared to the second cohort.
It was observed that the subjects dosed in the sentinel group showed no serious safety issues 24 hours after dosing.
Due to this reason, the company plans to complete the dosing of the remaining subjects in the third cohort over the next few days.
Once all the participants are dosed, complete follow up data will be presented to the safety review committee, which will then confirm if the trial can progress to the fourth and last cohort.
Based on data analysed from the first two participant cohorts in the Phase I trial, no clinically relevant changes were observed across all assessments carried out in either cohorts.
Of the possibly related adverse events (AEs) that were announced earlier, the safety review committee determined that they were not clinically significant and therefore ARG-007 doses appeared to be well tolerated and safe.
The committee further recommended that dose escalation could proceed.
Argenica Therapeutics CEO and managing director Dr Liz Dallimore said: “This is good news, and the trial is progressing extremely well, all participants dosed to date have shown good safety and tolerability profiles.
“The data from these first two cohorts, as well as the 24-hour sentinel data from the third cohort, gives us the confidence to look forward to our Phase II trial in stroke patients.
“This is a really exciting stage for the company, and we look forward to continuing to progress the clinical development of ARG-007.”
Conducted at Linear Clinical Research facility in Perth, Western Australia, the Phase I trial has been designed for evaluating ARG-007’s tolerability and safety across four cohorts of healthy adult volunteers.
Each cohort received an ascending dose of ARG-007.
In each cohort, the first volunteer dosed is a sentinel subject and receives the investigational drug at least 24 hours before the remaining subjects in the dose cohort.
A second volunteer receives a placebo saline injection simultaneously as the sentinel subject.