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MED™ 3D Printed Pharmaceutical Product Receives IND Clearance From the US FDA

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Triastek, Inc. (“Triastek”), a pharmaceutical company specializing in 3D printing of drug products, announced today that the United States Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) 505(b)(2) application for its first 3D printed drug product – T19, indicated for the treatment of rheumatoid arthritis (RA). Developed in-house, Triastek has global intellectual property rights to the T19 3D printed formulation.

The novel design made possible by 3D printing allows T19 to function as a chronotherapeutic drug delivery system, targeting the circadian nature of RA symptoms. Patients take T19 at bedtime with the tablet releasing drug in a delayed manner such that the blood concentration peaks in the early morning hours when the symptoms of pain, joint stiffness and dysfunction are most acute. T19 utilizes Melt Extrusion Deposition (MEDTM) 3D printing technology to achieve three-dimensional tablet structures that allow precise control of drug release to achieve the desired target PK in the human body, with the goal of addressing these unmet needs of RA patients.

It is predicted that by 2025, the global RA market will reach $30.7 billion (CAGR 4.5%), with T19's unique chronotherapeutic delivery system providing patients with a much-needed therapeutic option. Informa, a pharmaceutical market intelligence consulting company, suggests that T19 can capture substantial portion of RA market in China and the U.S after launch.

Triastek plans to apply for IND approval in China later this year, followed by applications in Japan and Europe. The New Drug Application (NDA) of T19 is expected to be filed to the U.S. FDA in 2023.

Following T19, Triastek has developed 505(b)(2) product portfolio to meet specific clinical needs and improve the outcomes of drug therapy using MEDTM 3D printing technology.

Background on MEDTM 3D printing technology

The MEDTM 3D printing technology platform encompasses digital pharmaceutical dosage form design, an efficient product development approach and automated intelligent manufacturing. Tablets can be constructed to have sophisticated shapes and internal geometric structures that serve to modulate the onset time, kinetics, duration, and mode of drug release with great predictability and reproducibility. This customizable release kinetics can help to enhance therapeutic effects, lower side effects, improve compliance, and efficiently develop pharmaceutical products in different stages.

Triastek has also developed a novel pharmaceutical product development method, 3D printing formulation by design (3DFbD®), to circumvent the trial and error or experience oriented traditional formulation development process. This methodology greatly improves the efficiency and success rate of drug product development, thereby reducing development time and costs. Moreover, integration of real-time Process Analytical Technology (PAT) in the continuous MEDTM 3D printing manufacturing system enables continuous monitoring of the manufacturing process to assure production quality, reduce manufacturing cost, and to provide convenience for regulatory monitoring.

In April 2020, Triastek’s MEDTM 3D printing was accepted into the FDA Emerging Technology Program (ETP). FDA recognized MEDTM 3D printing based on the following features: (a) the proposed use of a MEDTM based 3D technology to manufacture modified release solid oral dosage form, and (b) a fully automated process using PAT and feedback controls.

Dr. Senping Cheng, co-founder and CEO of Triastek, said, “Triastek is committed to improving the efficiency of formulation development, enhancing the effects of drug products, and ensuring the quality of drug delivered to patients by using 3D printing technology platform. The FDA IND clearance of T19 is an important milestone in the development and application of MEDTM 3D printing technology.”

Dr. Xiaoling Li, co-founder and CSO of Triastek, said, “We believe that the MEDTM 3D printing technology will be the enabler for digital pharmaceutical product development and intelligent drug manufacturing. Triastek will work with any interested parties to take advantage of this platform technology for developing pharmaceutical products with better clinical value and higher product quality.”

About Triastek, Inc.

Triastek is an international pharmaceutical company founded in July 2015 by Dr. Senping Cheng, who has entrepreneurial experience both in China and the United States, and Dr. Xiaoling Li, an American pharmaceutical scientist and educator. It is committed to building a novel 3D printing pharmaceutical technology platform for dosage form design, product development, and intelligent manufacturing. In-house product development and co-development with partners are two main business models; in terms of co-development, Triastek has reached a number of agreements with top multinational and Chinese pharmaceutical companies. Triastek’s mission is to be a global leader in the field of 3D printing pharmaceuticals and establish a new era of intelligent pharmaceutical manufacturing.

For more information, please visit Triastek’s website at https://www.triastek.com/indexen.html

Contact information

Business Development and Public Relations:
Eric Tsai
Business Development Director
etsai@triastek.com
M: +86 18502118450

Investor Relations:
Limin Zhang
Executive Assistant to CEO
lzhang@triastek.com
M: +86 13851775094

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