Clinical trials authorised for 3D-printed ulcerative colitis drug
The FDA gives clinical trial clearance to 3D-printed colon-targeted oral drug for ulcerative colitis, to help improve safety of the dosage release.
Triastek, Inc. a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs.
T21 is Triastek’s third FDA IND clearance for a 3D-printed medicine. Due to the drug being able to reach a targeted segment of the colon, a lower drug dose via controlled-release is possible compared to the reference listed drug. Radio-imaging agents embedded in specific components of the dosage form were added in early development of the formulation to assess and confirm the location of drug release in the GI tract. According to Triastek, the radio-imaging agents help protect the tablets from dissolving in the stomach.
Colon-targeted technology for ulcerative colitis treatment
The company’s delayed-release colon-targeted tablet technology allows for continuous manufacture to convert powder feedstocks into softened/molten states, followed by precise layer-by-layer deposition to produce objects with geometric structures. This enables controlled and precise location-specific, pre-determined dosage release of ulcerative colitis medicines in the body, ensuring a more targeted and efficacious delivery. The technology has the potential to develop small molecule drugs as well as peptide drugs and can be applied from early development through to commercial production.
“Delaying drug release and delivering oral dosage forms to the colon is challenging, so T21 offers a promising new option for ulcerative colitis patients by providing site-specific drug delivery and localised drug effect, mitigating potential side effects from systemic exposure. We look forward to advancing this treatment into the clinic,” acknowledged Dr Senping Cheng, founder and CEO of Triastek.
Triastek has already received IND clearance from the FDA for its T19 and T20 products for rheumatoid arthritis (RA) and cardiovascular and clotting disorders, respectively.
The first 3D-printed pharmaceutical, Spritam® (a levetiracetam tablet) was approved by the FDA in July 2015.