Highlights

  • FDA provided feedback on the proposed Phase II plan for SOF-SKN after a pre-IND meeting
  • The company said the agency was especially positive about the chemical manufacturing strategy
  • An extension study in about 15 patients with cutaneous lupus erythematosus is planned in Melbourne
  • Enrolment is targeted for Q1 CY27, with a full data readout expected in Q4 CY27
  • Phase II is targeted for H1 CY28, subject to regulatory, clinical and manufacturing requirements

Noxopharm (ASX:NOX) is an Australian clinical-stage company built around Sofra, its proprietary platform of synthetic nucleic acids (oligonucleotides) designed to mimic the body's natural immune regulators. Its lead candidate, SOF-SKN, is a topical therapy aimed at autoimmune skin disease. ASX announcements dated 14 September and 8 October 2026 set out a planned patient study in Melbourne and feedback received from the US Food and Drug Administration (FDA).

What the FDA Said About SOF-SKN

In its 8 October 2026 announcement, Noxopharm stated that the FDA had provided constructive feedback on the planned Phase II trial for SOF-SKN. The feedback followed a pre-IND meeting request announced on 7 July 2026.

According to the announcement, the FDA addressed trial design, manufacturing, non-clinical safety studies and other requirements for a future Investigational New Drug (IND) application. The company said the agency supported the overall approach, was especially positive about the chemical manufacturing strategy, viewed the proposed Phase II design as reasonable and gave technical guidance on non-clinical studies.

Chief Executive Officer Dr Olivier Laczka said engagement with the FDA at this stage is "a critical step in our progress along the clinical trials pathway".

The Cutaneous Lupus Extension Study

On 14 September 2026, the company announced that SOF-SKN would enter an extension study in patients with cutaneous lupus erythematosus (CLE), a form of lupus affecting the skin for which no targeted therapies are currently approved. The study follows completion of the HERACLES Phase I trial in healthy volunteers in January 2026.

The ASX:NOX update stated that approximately 15 patients will receive 14 days of daily topical SOF-SKN, followed by a 7-day follow-up. The study will assess safety, tolerability and initial efficacy signals in Melbourne, with dermatologist A/Prof Amanda Saracino as Lead Investigator.

Timelines the Company Has Outlined

The ASX:NOX announcement indicated the following expected timing:

- Enrolment from Q1 CY27, subject to ethics approval and other regulatory and contractual requirements - Initial efficacy signals in Q2 CY27 - A full data readout in Q4 CY27

The company said results are intended to inform a Phase II trial in CLE patients, targeted for H1 CY28. In the 8 October announcement it also said it plans to prepare a future IND submission for potential US development, and that SOF-SKN may qualify for Orphan Drug Designation.

Key Insights

The confirmed items are the two announcements: the FDA provided feedback at a pre-IND meeting, and Noxopharm has described a CLE extension study with a named lead investigator and location. These are regulatory and planning steps rather than clinical results, and the ASX:NOX announcements do not report efficacy data for SOF-SKN in patients.

Timelines for enrolment, efficacy signals, the data readout and Phase II are company expectations that remain subject to approvals, regulatory feedback, contractual arrangements and manufacturing requirements. The FDA feedback relates to a pre-IND discussion and is not an IND clearance, and Orphan Drug Designation was described only as a possibility. Any later US submission by ASX:NOX would be assessed separately.