Argenica Therapeutics Limited announced the release of the safety data for its Phase 1 clinical trial of ARG-007 in healthy human volunteers. The safety report, provided by Linear Clinical Research (Linear) who ran the Phase 1 trial, confirms that overall, single intravenous doses of ARG-007 at all doses administered were considered to be safe and well tolerated in this Phase 1 study. The safety data provides details of all adverse events observed in both ARG-007 treated groups and placebo groups.

An adverse event observed following the commencement of ARG-007 or placebo (saline) administration (termed treatment emergent adverse events or TEAEs), may or may not be related to the administration of the drug. Of all TEAEs observed, 54.2% of ARG-007 treated participants experienced at least one mild or moderate TEAE, whereas 62.5% of the placebo group experienced at least one mild or moderate TEAE. There was a total of 31 reported TEAEs in all participants, however only 10 of these were considered ‘related' to the administration of ARG-007.

Further, these related TEAEs were not dependent on the dose of ARG-007 administered, the highest dose did not result in any adverse events related to ARG-007 administration. Therefore, the safety data report concluded there were no clinically significant adverse events seen in the ARG-007 dosed participants at any of the doses tested. The data also provided an evaluation of laboratory parameters, vital signs, physical findings, and other observations related to safety, notably monitoring heart conditions through electrocardiograms (ECG).

No clinically significant findings were observed in any of these measures. In addition, the data provides findings on the presence of nine different cytokines which are typical immune dysfunction biomarkers, to investigate whether ARG-007 caused an immune reaction. There were no notable trends in changes from baseline levels over time within any of the treatment groups or as the dose increased, meaning ARG-007 does not induce an immune reaction when administered at any of the four doses tested.

These safety results will be included in Argenica's ethics submission for Phase 2 clinical trial in stroke patients later in CY2023.