Triastek has announced positive clinical results for the 3D printed drug D23. The Budesonide Ileum Targeted Tablets were developed specifically for the treatment of IgA nephropathy (IgAN). They are produced using the Melt Extrusion Deposition (MED) process, a proprietary technology based on the 3D Microstructure for Intestine Targeting (3DμS-IT) platform. This platform enables precise drug delivery in the intestine to release the drug directly in the ileum, the site of origin of the disease, to maximize therapeutic efficacy.
The clinical trial of D23 was conducted as a randomized, open-label, single-dose crossover study with four trial periods. A novel method of labeling the tablet components was used to track the gastrointestinal passage of the drug in vivo using X-ray imaging. The results showed that budesonide is only released in the ileum, whereby the maximum drug concentration is achieved precisely at the desired site of action. This mechanism should optimize the effect of budesonide on the immune system and thus offer a more effective treatment approach for IgAN patients.
Based on these results, D23 will be transferred to the next phase of clinical testing. The aim is to further evaluate the clinical efficacy of targeted budesonide release in IgAN patients. The MED-3D printing process enables precise control of drug release by adjusting retardation layers, layer thickness and material composition. This method offers precise control of drug release compared to conventional tableting techniques and allows for both immediate and sustained or pulsatile release patterns. The technology could therefore open up a new dimension in personalized drug development.
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