Noxopharm (ASX: NOX) has announced the successful completion of the second dosing cohort in its HERACLES trial, a first-in-human study for the novel autoimmune drug candidate SOF-SKN. The safety steering committee has confirmed that the dose level was safe and tolerable, allowing the study to proceed to a higher concentration in the next cohort. Noxopharm is an Australian clinical-stage drug development company focused on oncology and inflammation. The company’s primary focus is on enhancing the effectiveness and safety of cancer treatments.
The HERACLES trial is evaluating SOF-SKN, a topical therapy designed to treat autoimmune diseases like cutaneous lupus erythematosus (CLE). The trial, conducted in Australia, involves four escalating single-dose cohorts, each with four participants. This design is intended to minimise patient risk while determining an optimal dose for later trials. Each cohort undergoes extensive testing and monitoring over two weeks, with data reviewed by the safety steering committee before advancing.
In addition to the trial progress, Noxopharm reported promising preclinical results from a collaboration with US-based Tezcat Biosciences. Tezcat specialises in targeted drug delivery systems. The preclinical work demonstrated that Noxopharm can successfully tether oligonucleotides to Tezcat’s delivery system, creating a novel candidate with strong anti-inflammatory activity. These results highlight the adaptability of Noxopharm’s Sofra platform, complementing other delivery approaches being explored.
Noxopharm and Tezcat plan to advance their collaboration into animal model studies in the coming months to further explore systemic delivery opportunities. Dr Craig Ramirez, CEO of Tezcat, stated the findings provide a strong foundation to explore the potential of these oligos in both inflammatory diseases and cancer. Dr Gisela Mautner, CEO of Noxopharm, added that this work broadens the range of potential disease indications, particularly in cancer, and represents a unique opportunity to demonstrate systemic delivery of their Sofra oligos.
