Noxopharm (ASX:NOX) has moved to strengthen its US regulatory strategy by engaging a global clinical research organisation to prepare for a pre-Investigational New Drug meeting with the US Food and Drug Administration.
The company said the engagement with Novotech is intended to help assemble a data package and plan the clinical development pathway and manufacturing controls needed to support an IND application.
Company executives framed the pre-IND step as a strategic milestone that could increase SOF-SKN’s commercial appeal and make the asset more attractive to industry partners in the US and beyond.
SOF-SKN is being developed first for the treatment of chronic inflammation in cutaneous lupus erythematosus and could later be applied to other autoimmune skin diseases such as psoriasis and dermatomyositis.
The broader Sofra technology platform is a novel class of oligonucleotide-based therapeutics that regulate immune sensors and have potential applications in autoimmune conditions, including rheumatoid arthritis and diabetes, as well as oncology.
Noxopharm CEO Dr Olivier Laczka said, “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.”