Triastek’s 3D-printed D23 tablet shows strong clinical results for IgAN treatment

Triastek has reported promising clinical results for its 3D-printed drug delivery product, D23 (Budesonide Ileum Targeted Tablets), which is being developed for the treatment of IgA nephropathy (IgAN). The trial demonstrated that D23’s delayed-release formulation effectively delivers targeted budesonide therapy to the ileum, the site of IgAN disease progression. This innovation could mark a significant advancement in precision drug delivery, offering an optimized treatment approach for patients suffering from the chronic kidney condition.

D23 is produced using Triastek’s proprietary Melt Extrusion Deposition (MED) 3D printing technology, which is based on its 3D Microstructure for Intestine Targeting (3DμS-IT) platform. This advanced technology enables precise intestinal targeting, ensuring that budesonide reaches the ileum with controlled drug release. Unlike conventional delayed-release tablets, which rely on external coatings, D23’s printed microstructure allows for a highly customized release profile, improving treatment effectiveness and patient outcomes.

How Does D23’s Targeted Drug Delivery Work?

The D23 clinical study was designed to assess how the 3D-printed budesonide tablet interacts with the gastrointestinal (GI) system and whether its delayed-release formulation ensures that the drug reaches the desired ileal region. The trial followed a randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover design. Researchers employed an innovative method to track D23 tablet components in vivo, using X-ray imaging to monitor GI transit time and the precise moment of budesonide release.

The study results confirmed that D23 tablets remained intact until they reached the ileum, where the active ingredient was then released. This targeted drug delivery mechanism is crucial for treating IgAN, as it ensures that budesonide’s therapeutic effects are concentrated exactly where the disease originates. By bypassing unnecessary absorption in the upper GI tract, this approach is expected to enhance budesonide’s efficacy while reducing potential systemic side effects.

The pharmacokinetic (PK) profile obtained during the trial reinforced these findings. The data showed that budesonide exposure in the ileum was both consistent and predictable, demonstrating the precision of the 3D-printed drug delivery system. These results support the hypothesis that D23’s controlled-release formulation could provide more effective IgAN treatment compared to conventional steroid therapies.

Why Is Precise Drug Release Essential for IgAN Treatment?

IgAN, also known as Berger’s disease, is a chronic kidney condition caused by the accumulation of IgA deposits in the glomeruli, leading to inflammation and progressive kidney damage. Although budesonide has been used to treat IgAN, existing formulations often result in uncontrolled drug dispersion throughout the digestive system, limiting its effectiveness at the disease site.

Triastek’s 3D-printed budesonide tablet addresses this issue by ensuring that budesonide is released exactly where it is needed—the ileum, where immune system activation plays a critical role in IgAN progression. By delivering budesonide directly to the ileal region, D23’s delayed-release formulation has the potential to provide a more targeted anti-inflammatory effect, improving treatment outcomes while minimizing systemic steroid exposure.

What Makes Triastek’s 3D-Printed Drug Technology Unique?

Unlike traditional oral drug formulations, which rely on coating-based delay layers, Triastek’s Melt Extrusion Deposition (MED®) process allows for precise control over drug release timing and location. Through 3D microstructure customization, D23 tablets can be engineered to release drugs in a variety of ways, including immediate, sustained, or pulsed release, depending on patient needs.

This level of precision in drug design offers multiple benefits. Enhanced drug targeting reduces off-target effects, improving treatment adherence by providing more predictable therapeutic effects. The possibility of combination therapies also emerges, as multiple drugs can be integrated into a single tablet with different release profiles.

By leveraging 3D-printed drug delivery, Triastek is pioneering a new era of pharmaceutical innovation, making therapies more efficient, precise, and patient-friendly.

What’s Next for D23 in Clinical Development?

Following these positive clinical results, Triastek plans to advance D23 into the next phase of clinical trials, where the therapeutic benefits of targeted budesonide delivery will be further evaluated in IgAN patients. The company aims to assess long-term efficacy, patient response, and potential regulatory pathways for bringing D23 to market as a novel IgAN treatment.

If subsequent trials confirm D23’s clinical effectiveness, it could redefine the standard of care for IgAN by offering a more precise, effective, and tolerable treatment option compared to existing therapies.

Triastek’s innovative approach underscores the potential of 3D-printed pharmaceuticals in revolutionizing drug formulation and delivery. By optimizing medication bioavailability, absorption, and targeting, 3D-printed drug delivery systems like D23 could pave the way for more personalized and effective treatments across various medical conditions.

A Potential Breakthrough in IgAN Treatment

The success of D23’s targeted budesonide therapy highlights the potential for 3D-printed pharmaceuticals to transform drug delivery and improve treatment precision. With its delayed-release formulation, ileum-specific drug targeting, and predictable pharmacokinetics, D23 could offer a significant advancement in IgAN therapy, providing patients with a more effective and tolerable treatment option.

As Triastek moves forward with clinical development, the company remains at the forefront of pharmaceutical innovation, demonstrating how 3D printing technology can enhance drug efficacy, safety, and patient outcomes.