Noxopharm (ASX:NOX) has announced that its SOF-SKN lupus medication has successfully passed a set of important preclinical safety tests ahead of the upcoming HERACLES clinical trial.
The company said the tests are a requisite part of drug development before a Phase 1 clinical trial.
Two tests, the in vitro micronucleus and AMES tests, were designed to show that SOF-SKN’s active ingredient would not likely cause genetic mutations. A third measured the potential for cardiac toxicity (hERG study).
Noxopharm said SOF-SKN’s active ingredient passed the two in vitro genotoxicity studies and the cardiac safety test, with no safety issues identified.
The three studies were performed under international Good Laboratory Practice standards.
A fourth study examined the drug's safety when exposed to UV light (3T3 assay), which is especially relevant for a topical treatment. SOF-SKN passed the test with no safety issues identified.
The company is also currently undertaking the final in vivo study required by regulations as part of the clinical trial preparations, and will update shareholders on this in due course.
Noxopharm CEO Dr Gisela Mautner said, “Successfully passing these safety tests takes us a significant step closer to the clinic. They give us confidence that SOF-SKN will be safe for use in the HERACLES trial, and we will continue our preparations as quickly and efficiently as possible.”