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Triastek receives FDA clearance for 3D printed gastric retention product

T22 is a 505(b)(2) product for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH)

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The US Food and Drug Administration (FDA) has granted Triastek, a 3D printing pharmaceuticals company, clearance to proceed with the Investigational New Drug (IND) of the company’s 3D printed T22, making it the first 3D printed gastric retention product to receive this designation. Triastek is preparing to initiate clinical studies with T22 to fast-track product development.

Triastek’s T22 product is a 505(b)(2) product for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). T22 is produced using Triastek’s innovative Melt Extrusion Deposition (MED) plus Micro-Injection Molding (MIM) process and utilizes its 3D Microstructure for Gastric Retention (3DμS-GR) delivery technology platform. Compared with the current three times-a-day dosing of the originator product, T22 reduces the dosing frequency to once a day – simplifying the dosing regimen and improving medication adherence.

“Based on our proprietary 3D Microstructure for Gastric Retention delivery technology platform, the two products we developed, T20G and T22, have received IND clearance to proceed from regulatory agencies in China and the United States this year, marking the successful first step for Triastek’s this innovative delivery technology platform proceeding through regulatory review process,” said Dr. Senping Cheng, Founder and CEO of Triastek. “In 2021, Triastek and Sperogenix Therapeutics reached a co-development agreement regarding development and commercialization of T22 in East Asia to demonstrate the clinical application value of the 3D Microstructure Gastric Retention delivery technology. Based on the progress of T22, companies from several countries and regions have expressed interest in potential collaborations for product development utilizing this drug delivery technology platform.”

Triastek receives FDA clearance for T22 505(b)(2) 3D printed gastric retention product to proceed for the Investigational New Drug (IND).

Triastek has completed the development of the T22 gastric retention formulation, achieved positive results in terms of in vitro expansion time, mechanical strength and dissolution behavior, and completed PK studies of the T22 gastric retention prototype in beagle dogs. Pharmacokinetic studies have reportedly demonstrated that a once-daily dosing of the same total daily dose of the T22 gastric retention prototype gave comparable PK parameters as the TID dosing of the originator product.

With the FDA clearance to proceed with T22, it brings a total of four Triastek 3D printed drug products (T19, T20, T21, and T22) to the clinical development stage – ranking the company first in the global 3D printed drug field in terms of development product count. With the rapid advancement of the T-series pipeline and continuing validation of the clinical value of 3D printing drug technology, Triastek continues to develop new technologies and products for the global market. Currently, the company’s two key business models include ‘Product License-out Partnership’ and ‘Technology Platform Partnership’.

A PCT application has been submitted for the 3D Microstructure for Gastric Retention delivery technology and its unique Bloom Structure design developed by Triastek. Upon oral administration, the gastric retention prototype expands to a size larger than the diameter of the pylorus – prolonging gastric retention time. During the gastric retention period, the prototype releases APIs according to a predetermined programmed drug release behavior. While simplifying the dosage regimen, reducing the medication burden, and improving the patient’s long-term medication adherence, it can also improve drug absorption and oral bioavailability resulting in improved patient outcomes.

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