Triastek
2023 TCT Healthcare Application Award Winner Triastek has announced that the U.S. Food and Drug Administration (FDA) has granted clearance to proceed for the Investigational New Drug (IND) of the company’s 3D printed product T22, making it the first 3D printed gastric retention product to receive this designation.
Triastek says it 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 Melt Extrusion Deposition plus Micro-Injection Molding (MED&MIM) process, and utilises 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, which the company says simplifies the dosing regimen and improves medication adherence.
Dr. Senping Cheng, Founder and CEO of Triastek said: “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 innovative deliver technology platform proceeding through the regulatory review process.
“In 2021, Triastek and Sperogenix Therapeutics reached a co-development agreement regarding development and commercialisation 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 utilising this drug delivery technology platform.”
Triastek says it has completed development of the T22 gastric retention formulation, achieved positive results in terms of in vitro expansion time, mechanical strength and dissolution behaviour.
With the FDA clearance to proceed with T22, this brings a total of four Triastek 3D printed drug products, T19, T20, T21, and T22, to the clinical development stage, ranking first in the global 3D printed drug field in terms of development product count according to the company.
In September 2023, completed a 20.4 million USD funding round to accelerate the commercialisation of its 3D printing pharmaceutical technologies.
