Country for PR: China
Contributor: PR Newswire Asia (China)
Tuesday, November 22 2022 - 00:00
Triastek Receives FDA IND Clearance for 3D Printed Medicine for the Treatment of Ulcerative Colitis
NANJING, China, Nov. 21, 2022 /PRNewswire-AsiaNet/ --

-Triastek's third FDA IND clearance for a 3D printed medicine
-T21, a novel potential treatment capable of colon-targeted drug delivery

Triastek, Inc. ("Triastek") a global healthcare company pioneering 3D printing 
of pharmaceuticals with its proprietary technology, Melt Extrusion Deposition 
(MED®), announced today that it has received clearance for its Investigational 
New Drug (IND) application from the United States Food and Drug Administration 
(FDA) to initiate clinical studies of the 3D printed medicine, T21, a potential 
treatment for ulcerative colitis.

"We are excited to receive IND clearance to begin clinical trials of this 
potentially transformative treatment for patients, " said Dr. Senping Cheng, 
founder and CEO of Triastek. "Delaying drug release and delivering oral dosage 
forms to the colon is challenging, so T21 offers a promising new option for 
patients by providing site-specific drug delivery and localized drug effect, 
mitigating potential side effects from systemic exposure. We look forward to 
advancing this treatment into the clinic and appreciate the FDA's support."

T21 is a novel potential treatment capable of colon-targeted drug delivery. 
With a unique 3D dosage form design, T21 can reach the targeted colon segment 
of the GI tract, thus permitting use of a lower drug dose than the reference 
listed drug, which provides systemic exposure. Made possible by 3D printing, 
radio-imaging agents embedded in specific components of the dosage form were 
employed in early formulation development to evaluate and confirm the location 
of drug release in the GI tract. This novel process can be utilized in the 
development of future drugs targeted to specific segments of the GI tract to 
increase the efficiency and success rate of product development. The 
delayed-release, colon-targeted oral tablet technology platform can not only be 
used for developing small molecule drugs, but for peptide drugs as well.

Triastek had already received IND clearance from the FDA for its T19 and T20 
products for treatment of rheumatoid arthritis and cardiovascular and clotting 
disorders, respectively. Triastek continues to demonstrate the broad 
applicability of its MED® technology through the advancement of products that 
solve a wide range of drug delivery challenges across multiple therapeutic 

About Triastek

Triastek, Inc. is a global healthcare company, developing medicines with 
proprietary, pioneering 3D printing technology. Triastek is dedicated to 
revolutionizing the development and manufacturing of pharmaceutical products 
and unlocking the next generation of medicine through 3D printing technology. 
Its state-of-the-art technology, called Melt-Extrusion Deposition (MED®), 
facilitates the development of medicines in a layered construction to enable 
controlled and precise release of treatments. This optimized treatment design 
helps control when, where and how much medicine is released in the body, 
ensuring a more targeted and efficacious delivery.

About Melt-Extrusion Deposition (MED®)

Melt-Extrusion Deposition (MED®) 3D printing is an additive manufacturing, 
end-to-end technology that continuously converts powder feedstocks into 
softened/molten states followed by precise layer-by-layer deposition to produce 
objects with well-designed geometric structures.

SOURCE:Triastek, Inc.

Image Attachments Links:


   Caption: Triastek’s Colon-targeted Drug Delivery Dosage Form Development


   Caption: Triastek’s Three Products Enter the Clinical Development Phase 
within Two Years

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