PR98886

NANJING, China, Nov. 21, 2022 /PRNewswire=KYODO JBN/ --

-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

areas.

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:

   Link: http://asianetnews.net/view-attachment?attach-id=434283

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

   Link: http://asianetnews.net/view-attachment?attach-id=434284

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