Noxopharm (ASX:NOX) has been granted approval by the Human Research Ethics Committee for the HERACLES clinical trial following a straightforward review process.
HERACLES will be a first-in-human trial of Noxopharm's SOF-SKN, a novel drug candidate for chronic inflammatory diseases.
The study aims to evaluate 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 research for inflammatory diseases such as lupus, as well as early-phase clinical trials.
The company stated that it will work closely with the Doherty Clinical Trials team in Melbourne to expedite the operational aspects of the trial. These include activities such as undertaking site initiation, preparing and shipping the trial-specific batches of SOF-SKN, and screening and recruiting trial participants.
Noxopharm CEO Dr Gisela Mautner said, “The granting of ethics approval for the first ever clinical trial from our Sofra technology platform is an important milestone. The quick approval is testament to the thorough preparation of the dossier by our team and also a very efficient review process by the committee, for which we are very grateful.
“Our team has rapidly developed this drug, successfully navigated its way through extensive preclinical testing, and prepared a robust data package that has now culminated in the trial. We have a lot of work in front of us, but we have planned everything in great detail and will be able to start the trial very quickly. It’s an exciting time, and we will of course keep shareholders updated as these activities progress.”
