Noxopharm (ASX:NOX) has announced that recruitment activities are progressing rapidly and on schedule for the HERACLES clinical trial.
HERACLES is a first-in-human trial for Noxopharm's SOF-SKN, a first-in-class drug candidate for autoimmune diseases.
The study is evaluating the safety profile of SOF-SKN by testing it at four different concentrations. It will take place in Australia to capitalise on local expertise in lupus research and early-phase clinical trials.
Noxopharm said the recruitment phase involves a wide array of activities such as advertising the trial to potential subjects, as well as the identification, pre-screening, and later full screening of participants to ensure they meet all eligibility criteria before formal enrolment.
As part of the initial trial activities, representatives from Noxopharm, the team at Doherty Clinical Trials and other relevant parties have already completed their mandatory training.
Noxopharm said it has also finalised its SOF-SKN manufacturing and is in the last stages of quality control, while also confirming the drug is appropriately labelled and packaged to regulatory standards before being prepared for shipping to the trial site.
CEO Dr Gisela Mautner said, “Following our recent ethics approval, we are now moving full steam ahead as we work through the operational aspects of the trial. It’s great to see that recruitment activities and outreach to potential participants has been pleasingly fast, and we will keep shareholders updated as we move into the dosing stage.”
SOF-SKN is initially targeted at cutaneous lupus erythematosus before potential development for autoimmune-related skin diseases like psoriasis and atopic dermatitis.