Biora Therapeutics has generated more evidence that the delivery device behind its spin on Xeljanz can get drugs safely to targets in the gut, regardless of whether the recipient is fed or fasted.
The biotech, which was called Progenity before its pivot to oral drug delivery, is developing a capsule that is designed to release a therapeutic payload at specific locations in the gastrointestinal tract. Ahead of the start of a phase 1 clinical trial of lead candidate PGN-600, Biora has been assessing the safety and functionality of the delivery system.
In the second of the three studies, 12 participants were required to ingest four capsules. One participant only ingested two capsules and it was impossible to retrieve data from seven devices, leaving Biora with insights into the passage of 39 capsules through the digestive system.
None of the analyzed devices exhibited failure modes, contributing to Biora’s conclusion that all capsules entered the colon, activated and deployed. The capsules worked in both fasted and fed participants, encouraging Biora that its system is differentiated.
“These data suggest that the DDS capsule could be the first ingestible therapeutic delivery device that does not require fasting or other food restriction for use. This could be an important consideration for patients who need frequent administration of dosing in chronic diseases like ulcerative colitis,” Biora CEO Adi Mohanty said in a statement.
Biora is now closing in on the start of clinical development of its lead candidate. Results from a clinical device performance study in active ulcerative colitis patients are due in the third quarter. A phase 1 trial of lead candidate PGN-600 is slated to start by the end of the year.
PGN-600 contains a liquid formulation of tofacitinib, the active ingredient in Pfizer’s Xeljanz. By getting a liquid formulation of the JAK inhibitor to the colon, Biora is aiming to improve the treatment of inflammatory bowel disease.