How Noxopharm’s HERACLES Trial Safety Win Fuels SOF-SKN™’s Next Phase
Noxopharm has successfully completed the final multiple-dose cohort of its HERACLES trial for SOF-SKN™, reporting no significant safety concerns and paving the way for Phase II-enabling studies.
- Final multiple-dose cohort of HERACLES trial completed
- No clinically relevant safety issues detected
- High participant compliance with SOF-SKN™ dosing
- Phase II-enabling studies and drug scale-up planned
- SOF-SKN™ targets autoimmune skin diseases like cutaneous lupus erythematosus
HERACLES Trial Completion Marks a Milestone
Australian biotech company Noxopharm Limited has announced the successful completion of the second and final multiple-dose cohort in its HERACLES clinical trial for SOF-SKN™, a topical treatment targeting chronic inflammation in autoimmune skin diseases. The Safety Steering Committee overseeing the trial confirmed that SOF-SKN™ was safe and well tolerated, with no clinically relevant issues emerging across all dosing groups.
This marks the conclusion of the clinical phase of the HERACLES trial, which progressed swiftly from recruitment through single and multiple-dose cohorts. The trial also saw strong participant adherence to the dosing regimen, underscoring the practicality of SOF-SKN™’s application.
Implications for Noxopharm’s Development Pipeline
With safety concerns effectively addressed, Noxopharm is now poised to advance SOF-SKN™ into Phase II-enabling studies and initiate drug scale-up processes. These next steps are crucial for validating the drug’s efficacy and preparing for broader clinical testing, particularly targeting cutaneous lupus erythematosus (CLE), an autoimmune condition characterised by chronic skin inflammation.
CEO Dr Gisela Mautner expressed pride in the trial’s execution and highlighted the company’s focus on moving swiftly towards testing SOF-SKN™ in lupus patients. The drug’s potential extends beyond CLE, with possible applications in other autoimmune-related skin diseases such as psoriasis and dermatomyositis, as well as systemic conditions linked to immune dysregulation.
Broader Market and Technological Context
SOF-SKN™ is built on Noxopharm’s proprietary Sofra™ technology platform, which utilises short nucleic acid sequences to modulate immune system sensors and regulate inflammation at its source. This innovative approach aims to replicate natural immune regulation that is deficient in autoimmune diseases.
The global market for CLE treatments alone exceeds US$3.3 billion and is expected to grow substantially, while the broader autoimmune therapeutics market is projected to reach over US$219 billion by 2035. Noxopharm’s technology also holds promise for conditions like rheumatoid arthritis and diabetes, positioning the company well within a rapidly expanding sector.
Collaboration with respected institutions such as Doherty Clinical Trials and the Hudson Institute of Medical Research has been instrumental in the trial’s success, reflecting a strong foundation for future clinical and commercial endeavours.
Bottom Line?
Noxopharm’s clean safety slate in HERACLES sets the stage for critical Phase II studies that will test SOF-SKN™’s therapeutic promise.
Questions in the middle?
- When will Noxopharm initiate and report results from the Phase II-enabling studies?
- What efficacy signals, if any, emerged during the HERACLES trial despite its safety focus?
- How will Noxopharm position SOF-SKN™ competitively within the expanding autoimmune therapeutics market?
