Biora Therapeutics announces successful completion of device performance study in ulcerative colitis patients for its Targeted Therapeutics Platform.
Biora Therapeutics, Inc. announced topline results from its recently completed study PM 602: A Scintigraphic Study to Evaluate the Localization and Delivery Function of a Drug Delivery System Capsule (DDS) in Subjects with Ulcerative Colitis in a Fasted State
The study demonstrated that the device was well tolerated, and that the device performed as intended in active ulcerative colitis (UC) patients. In all seven patients, the device accurately identified entry into the colon, triggered release of a liquid payload, and achieved distribution across the entire colon.
During the PM 602 study, Biora’s device was ingested orally by seven patients with active ulcerative colitis in a single dosage event. After identification of colon entry, the device released a saline solution payload that included radioisotopes. Serial gamma-scintigraphy images were used to independently determine device localization and payload delivery to the lower gastrointestinal tract. No investigational drug was administered during the study. More information on the PM 602 study will be released as analysis is completed and submitted for publication.
For the 1.8 million patients in the United States who suffer from inflammatory bowel disease (IBD), existing therapeutics offer less than ideal efficacy, likely because of the challenges with safely achieving sufficient drug levels in the affected tissues. Recent data have shown that targeted delivery of therapeutics has the potential to improve patient outcomes in IBD.
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