Safety Success for Noxopharm’s Lupus Drug Reduces Clinical Development Risk
Noxopharm has successfully completed key in vitro safety tests for its SOF-SKN™ lupus drug, paving the way for the upcoming HERACLES Phase 1 clinical trial.
- SOF-SKN™ passed four stringent in vitro safety studies
- Tests included genotoxicity, cardiac toxicity, and UV exposure assessments
- Studies conducted under international Good Laboratory Practice standards
- Final in vivo safety study underway to complete clinical trial requirements
- Progress advances preparations for HERACLES Phase 1 clinical trial
Preclinical Safety Milestone Achieved
Australian biotech Noxopharm Limited (ASX:NOX) has announced a significant step forward in the development of its SOF-SKN™ medication for lupus. The drug has successfully passed a series of four critical in vitro safety tests, a mandatory regulatory prerequisite before advancing to human clinical trials.
These tests are designed to evaluate potential risks such as genetic mutations and cardiac toxicity, which are key concerns for any new pharmaceutical candidate. SOF-SKN™ cleared the in vitro micronucleus and AMES assays, which assess genotoxicity, as well as the hERG assay, which screens for cardiac safety. Additionally, the drug passed a UV exposure safety test relevant to its topical application.
Rigorous Standards and Regulatory Confidence
Importantly, all studies were conducted under internationally recognised Good Laboratory Practice (GLP) standards, ensuring the integrity and reliability of the data submitted to regulatory authorities. This level of stringency is essential for gaining approval to initiate Phase 1 clinical trials, underscoring the robustness of Noxopharm’s preclinical program.
CEO Dr Gisela Mautner emphasised the significance of these results, stating that passing these safety hurdles brings the company closer to commencing the HERACLES clinical trial. The company is concurrently finalising the last required in vivo safety study, which will complete the dossier needed for regulatory submission.
Strategic Implications and Next Steps
SOF-SKN™ is part of Noxopharm’s Sofra™ technology platform, which targets inflammation and autoimmune conditions. The successful completion of these safety tests not only validates the drug’s safety profile but also strengthens investor confidence in the company’s clinical pipeline.
Looking ahead, the market will be closely watching the initiation and progress of the HERACLES trial, which will provide the first human data on SOF-SKN™’s efficacy and safety. Positive clinical outcomes could position Noxopharm as a notable player in the lupus treatment landscape, a field with significant unmet medical need.
Bottom Line?
With safety hurdles cleared, all eyes now turn to the HERACLES trial’s clinical readouts.
Questions in the middle?
- When will Noxopharm complete and report the final in vivo safety study?
- What are the expected timelines for the HERACLES Phase 1 trial commencement and data release?
- How might SOF-SKN™’s safety profile compare to existing lupus treatments in clinical settings?
