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- Preparations underway for US FDA pre-IND meeting
- Move to boost SOF-SKN treatment commercial potential
- Global clinical research organisation signed
- Global CLE market is worth more than US$3.3 billion and
Clinical-stage Australian biotech company Noxopharm (ASX:NOX) has engaged a global clinical research organisation to support it in the lead-up to a pre-investigational new drug (IND) meeting with the US Food & Drug Administration (FDA).
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The move to bring in the internationally recognised full-service clinical research organisation (CRO) and scientific advisory company 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.
SOF-SKN is a topical treatment that targets an inflammatory sensor called Toll-like receptor 7 (TLR7) using a novel strategy.
CEO Dr Olivier Laczka said 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.
Dr Laczka said that 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.
“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 SofraTM technology platform more broadly.”
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.
The global CLE market is worth more than US$3.3 billion and is expected to grow significantly over the coming years. The core Sofra technology could also be further utilised for rheumatoid arthritis and diabetes, plus other diseases linked to immune system dysregulation.
NOX is steady at 7.0¢. Mkt cap $21.50M.
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