Noxopharm Advances HERACLES Trial as Sofra Platform Gains US Momentum

Noxopharm (ASX: NOX) has successfully completed the second dosing cohort in its first-in-human HERACLES trial for novel autoimmune drug candidate SOF-SKN.

The safety steering committee confirmed the dose level was safe and tolerable, enabling the study to progress to a higher concentration in the next cohort.

The company also reported promising preclinical results from a US collaboration that could extend the reach of its Sofra technology into cancer and inflammatory disease markets.

Second Cohort Clears Safety Hurdle

The HERACLES trial is evaluating SOF-SKN, a topical oligonucleotide-based therapy designed to treat autoimmune diseases such as cutaneous lupus erythematosus (CLE).

Conducted in Australia, the study’s first phase involves four escalating single-dose cohorts, each with four participants.

The stepwise design aims to minimise patient risk while identifying an optimal dose for later-stage trials.

Each two-week cohort undergoes extensive testing and monitoring, with data reviewed by the safety steering committee before approval is granted to advance to the next dose level.

Strategic Focus on Safety and Market Potential

Safety is a central priority in the program, reflecting industry data that around 30% of drug candidates fail due to unmanageable toxicity. The company says the trial’s local setting supports access to specialist lupus expertise and federal R&D tax incentives.

SOF-SKN will target the US$3.3 billion CLE market initially, with potential future indications in psoriasis, dermatomyositis, rheumatoid arthritis, type 1 diabetes, inflammatory bowel disease and other immune-related disorders.

The drug is built on the Sofra platform, which uses proprietary oligonucleotides to modulate inflammation at its source, offering a broad development pipeline across autoimmune and inflammatory diseases.

US Partner Demonstrates Sofra Versatility

In parallel with the trial, New York-based Tezcat Biosciences has delivered encouraging in vitro results using Noxopharm’s Sofra assets.

Tezcat specialises in targeted drug delivery systems capable of transporting therapeutic payloads directly to immune and cancer cells.

Its preclinical work showed Noxopharm can successfully tether oligonucleotides to its delivery system, producing a novel candidate with strong anti-inflammatory activity.

The results demonstrate the platform’s adaptability, complementing other delivery approaches such as topical administration in HERACLES and antibody-drug conjugates in development with BioRay.

Collaboration Progressing to Next Stage

Noxopharm and Tezcat plan to advance the collaboration into animal model studies in the coming months to further explore systemic delivery opportunities.

Tezcat chief executive Dr Craig Ramirez said the findings provided a strong foundation to “look further into what these oligos can do in both inflammatory diseases and cancer.”

Noxopharm chief executive Dr Gisela Mautner said the work “broadens our range of potential disease indications, including in the cancer space” and represents “a unique opportunity to demonstrate systemic delivery of our Sofra oligos.”