- the Triassic‘3D Printed T22 Gastric Retention Product Received IND Clearance from FDA, Becoming the Global Product‘The first 3D printed gastric retention product.
- Currently, Triastek has four 3D printed products, T19, T20, T21 and T22, which have obtained IND clearance from the FDA, placing Triastek at the forefront in the global field of 3D printing for pharmaceutical clinical development.
NANJING, CHINA – Media OutReach Newswire – February 1, 2024 – January 27
the Triassic announced that the U.S. Food and Drug Administration (FDA) has granted approval to proceed with investigational new drug (IND) development for the company’s 3D printed product, T22, making it the first 3D printed gastric retention product to receive this designation. Triastek is preparing to launch clinical studies with T22 to accelerate product development.
Triastek’s T22 3D Printed Gastric Retention Product Receives FDA Clearance for IND Application
Triastek’s T22 is a 505(b)(2) product intended for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). The T22 is produced using Triastek’s innovative fusion extrusion deposition and microinjection molding (MED&MIM) process and uses its 3D microstructure for gastric retention (3DμS®-GR) delivery technology platform. Compared to the current administration of the original product three times per day, T22 reduces the dosing frequency to once per day, thereby simplifying the dosing regimen and improving treatment compliance.
Dr. Senping Cheng, Founder and CEO of Triastek, said: “Based on our proprietary 3D microstructure delivery technology platform for gastric retention, the two products we developed, T20G and T22, have received approval IND from regulatory agencies in China and the United States this year, marking the first successful step for this innovative delivery technology platform from Triastek moving through the regulatory review process.
In 2021, Triastek and Sperogenix Therapeutics entered into a co-development agreement regarding the development and commercialization of T22 in East Asia to demonstrate the clinical application value of 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 using this drug delivery technology platform.
Triastek 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 pharmacokinetic studies of the T22 gastric retention prototype in beagle dogs. Pharmacokinetic studies demonstrated that once-daily administration of the same total daily dose of Prototype Gastric Retention T22 resulted in pharmacokinetic parameters comparable to TID administration of the original product.
With FDA clearance to proceed with T22, this brings a total of four 3D printed pharmaceutical products from Triastek, T19, T20, T21 and T22, to the clinical development stage, ranking first in the global field 3D printed drugs in terms of development. number of products. With the rapid advancement of the T-Series pipeline and continued validation of the clinical value of 3D printing drug technology, Triastek continues to develop new technologies and products for the global market. Currently, our two key business models include “Product Licensing Partnership” and “Technology Platform Partnership”.
About Triastek‘3D microstructure technology platform for gastric retention
A PCT application was submitted for the 3D microstructure delivery technology for gastric retention and its unique Bloom structure design developed by Triastek. Upon oral administration, the prototype gastric retention expands to a size greater than the diameter of the pylorus, thereby prolonging the gastric retention time. During the gastric retention period, the prototype releases APIs according to a predetermined programmed drug release behavior. While simplifying the dosing regimen, reducing drug burden, and improving long-term patient compliance, it can also improve drug absorption and oral bioavailability, leading to better patient outcomes.
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