Noxopharm (ASX:NOX) has announced that its SOF-SKN lupus medication has passed its final in vivo preclinical safety study before regulatory submission for the upcoming HERACLES clinical trial.
The study examined numerous safety and toxicity criteria to ensure that there were no clinically relevant adverse effects and that the drug would be considered safe to give to trial participants.
Noxopharm said that beyond the standard clinical observations, the study involved a comprehensive battery of tests and measurements covering cardiac, respiratory and neurological functions, dermal toxicity, haematology, serum chemistry, toxicokinetics, and histopathology of all vital organs and tissues.
"No clinically relevant safety issues were identified," said the company, adding that the
next milestone is to apply for Human Research Ethics Committee approval for the clinical trial.
Noxopharm CEO Dr Gisela Mautner said, “These results mean we have now cleared the last preclinical testing milestone ahead of our ethics submission for the trial. The accelerated pace with which we have progressed SOF-SKN reflects our determination to explore the potential of this innovative technology in a clinical setting as quickly as possible.
“Our approach to investigating lupus in the clinic opens the way to potentially moving seamlessly into larger autoimmune disease markets beyond lupus such as rheumatoid arthritis, psoriasis, type 1 diabetes, inflammatory bowel disease and other inflammatory diseases linked to the dysregulation of the immune system, such as dementia.”