Triastek Reports Positive FIH Results from Study of T21, a 3D Printed Oral Treatment for Moderate to Severe Ulcerative Colitis

The study verified the ability for Triastek’s 3D Microstructure for Colon Targeting (3DμS-CT) to precisely target and release medication in the colon

NANJING, China — Triastek, Inc. (“Triastek”), a global healthcare company developing medicines with proprietary, pioneering 3D printing process, today announced they have completed its first human (FIH) study of its third 3D printing drug product, T21, designed to treat moderate to severe ulcerative colitis (UC). Imaging results from the study confirmed that T21 tablets are precisely delivered and released to the target site – the colon – for the drug’s release.

The administration of oral medication is generally regarded as the preferred method for patients with UC due to its safety, pain avoidance and patient compliance. However, it has been historically difficult to achieve precise delivery of drugs to the colon, without releasing any of the medication in different parts of the gastrointestinal tract. Triastek developed T21 in an effort to solve the problem of targeted and precise delivery of oral drugs to the gastrointestinal tract. Through the company’s proprietary Melt Extrusion Deposition (MED) 3D printing process, its 3D printed tablets have the unique ability to control when, where and how much medicine is released in the gastrointestinal tract, ensuring a more targeted and efficacious drug delivery.

T21 FIH Three-dimensional Structure Design

“The first human study data with T21 verifies the precise colon delivery capability of the MED process, and this platform is poised to become the novel drug delivery system of choice for new colon-targeted products with either local efficacy or systemic absorption,” said Professor Xiaoling Li, co-founder and chief scientific officer of Triastek. “We hope to continue showcasing how Triastek’s 3D printing processes can bring technical solutions to pharmaceutical companies for efficient product development of optimized drug delivery, ultimately leading to the ability to provide patients with more clinically valuable medicines.”

Triastek aims to develop partnerships with pharmaceutical companies to help it differentiate its products through the use of 3D printing of medicines. Triastek has most recently partnered with Boehringer Ingelheim, Eli Lilly and Merck KGaA.

About Triastek

Triastek, Inc. is a global healthcare company, developing medicines with proprietary, pioneering 3D printing process. Triastek is dedicated to revolutionizing the delivery, development and manufacturing of pharmaceutical products by unlocking the next generation of medicine through the use of 3D printing process. Its state-of-the-art process, called Melt Extrusion Deposition (MED), facilitates the development of medicines with complex structures to enable controlled and precise release of treatments. Since 2021, three products independently developed by Triastek, T19, T20 and T21, have successfully obtained clinical trial approval from the US FDA.

https://www.triastek.com/

About T21

T21 is Triastek’s third 3D printed drug product, and is an oral, colon-targeted delivery drug for moderate to severe ulcerative colitis (UC). On November 18, 2022, T21 received clearance for its Investigational New Drug (IND) application from the United States Food and Drug Administration (FDA) through the 505(b)(2) pathway. The original drug is an oral Janus kinase (JAK) inhibitor called tofacitinib. Following the approval of T21, Triastek launched FIH research in Q1 of 2023 to verify the transport, erosion process and release site of T21 in the human body after oral administration. At present, T21 has completed the FIH study, and imaging results have confirmed that T21 tablets are accurately delivered to the target site – the colon.

About Melt Extrusion Deposition (MED)

MED 3D printing is an additive manufacturing, end-to-end process that continuously converts powder feedstocks into softened/molten states followed by precise layer-by-layer deposition to produce objects with well-designed geometric structures. This optimized product design helps control when, where and how much medicine is released in the gastrointestinal tract, ensuring a more targeted and efficacious drug delivery. MED processes can be used to design and develop new chemical entities (NCE) as well as highly differentiated lifecycle management products for unmet medical and clinical needs.

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