Argenica Therapeutics Limited announced the approval by the Phase 1 Safety Review Committee (SRC) to progress to the second escalated dose cohort. Following an extensive review of data from the first cohort of participants, including blood pressure, vital signs, neurological examinations, haematology, and adverse events, the SRC determined that there were no clinically relevant abnormal results, and therefore the trial can progress to the next dose escalated cohort. Of the eight participants dosed (six receiving ARG-007 and two receiving a placebo), no serious adverse events were observed following dosing.

Further information on non-serious adverse events has now been provided to Argenica and the SRC by the trial Clinical Research Organisation, Linear Clinical Research (Linear). Only one participant in the cohort experienced some non-serious adverse events that were possibly related to the drug administration. The non-serious adverse events experienced by this participant were a headache and dizziness, both of which resolved quickly.

Linear has confirmed that these are common Phase 1 trial participant symptoms, including in placebo groups. As the study is currently blinded it is not known if this participant received the placebo or ARG-007. Argenica will provide further information on the trial progress as it is received from Linear.