Innovative biotech company Noxopharm's (ASX:NOX) SOF-SKN lupus medication has successfully passed a set of important preclinical safety tests ahead of the upcoming HERACLES clinical trial.
These tests are a requisite part of drug development prior to a Phase 1 clinical trial. Two of the tests were designed to show that SOF-SKN’s active ingredient would not be likely to cause genetic mutations (in vitro micronucleus and AMES tests), while a third measured the potential for cardiac toxicity (hERG study).
SOF-SKN’s active ingredient passed the two in vitro genotoxicity studies and the cardiac safety test with no safety issues identified.
These three studies were performed under international Good Laboratory Practice (GLP) standards, which assure a high level of quality and integrity of preclinical safety data. This stringency is required to satisfy regulatory authorities when applying for human trials.
A fourth study examined the safety of the drug when exposed to UV light (3T3 assay), which is especially relevant for a topical treatment. Again, SOF-SKN passed this 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.
“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," CEO, Dr Gisela Mautner, said.