• Preparations for US FDA pre-IND meeting
• Move to boost SOF-SKN's commercial potential
• Engagement of global clinical research organisation

Noxopharm Limited (ASX:NOX) has engaged a global clinical research organisation in the lead-up to a pre-Investigational New Drug (IND) meeting with the US Food & Drug Administration. The move will provide support to Noxopharm in preparing a data package suitable for a meeting with the FDA to discuss the planned clinical development pathway and requirements to support an IND application for SOF-SKN. Pre-IND meetings represent an important milestone in the drug development process and require significant planning. During the meetings companies can obtain feedback on the design of both preclinical studies and clinical trials, as well as product manufacturing and quality controls. The meeting is a strategic engagement with the US regulatory authority to optimally prepare for a subsequent IND application submission. From Noxopharm's strategic perspective, securing a successful IND application would likely increase SOF-SKN's commercial potential and make the drug more attractive to potential industry partners in both the US and elsewhere. To help streamline the regulatory process, the company has engaged Novotech, a globally recognised full-service clinical research organisation (CRO) and scientific advisory company. SOF-SKN is initially being developed for the chronic inflammation caused by the autoimmune disease cutaneous lupus erythematosus (CLE), before potential development for other autoimmune-related skin diseases like psoriasis and dermatomyositis.

Boosting SOF-SKN's attractiveness in the market is a top priority and engaging Novotech is an important step along this road from a regulatory perspective. A pre-IND meeting opens the way to a subsequent full IND application in the US, further demonstrating the robustness of our data and the genuine potential of both our drug candidate and our Sofra™ technology platform more broadly.