Biora Therapeutics Presents Clinical Data on Device Function of the NaviCap™ Platform at Digestive Disease Week 2024
Four clinical device performance studies successfully demonstrate the NaviCap platform’s ability to deliver therapeutics directly to the colon under variable GI conditions and eating schedules
SAN DIEGO, May 20, 2024 (GLOBE NEWSWIRE) -- (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, presented a poster titled “Results of human device function studies for the NaviCap™ Targeted Oral Delivery Platform in healthy volunteers and patients with UC” at the Digestive Disease Week® conference in Washington DC, on Sunday, May 19, 2024.
“In four separate clinical studies, we evaluated the functionality and safety of the NaviCap device in healthy participants and in patients with active ulcerative colitis (UC),” said Ariella Kelman, MD, Chief Medical Officer of Biora Therapeutics. “The NaviCap device was well-tolerated in 81 administrations to 47 participants, releasing its payload in the colon, regardless of variable GI transit time, the level of inflammation, or the presence of blood in stool. The NaviCap platform’s ability to function across variable GI conditions and eating schedules illustrates its potential to deliver therapeutics locally to the colon of patients with UC.”
The NaviCap platform uses an ingestible device designed for targeted delivery of therapeutics to improve treatment of IBD. Once swallowed, Biora’s GItrac™ autolocation technology enables the device to autonomously identify targeted locations in the GI tract and release its payload.
Four clinical device performance studies evaluated the functionality and safety of the NaviCap device. Three studies (PM-601, PM-602, and BT-603) used gamma scintigraphy to assess delivery of radiolabeled payload into the colon in either healthy participants or patients with active UC, and one study (PM-611) assessed device function in healthy participants in both fasted and fed states. All devices were safely ingested and exited the body naturally, with no serious adverse events reported. No investigational drug was administered during the studies. The poster can be viewed by visiting .
About Digestive Disease Week
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 18-21, 2024. The meeting showcases more than 5,600 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at .
About the NaviCap™ Targeted Oral Delivery Platform
utilizes a novel approach that could improve patient outcomes by enabling delivery of therapeutics directly to the site of disease, increasing therapeutic levels in tissue while reducing systemic uptake. 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. that targeted delivery of therapeutics has the potential to improve patient outcomes in IBD.
The NaviCap platform uses an ingestible device to the GI tract to improve treatment of IBD. Once swallowed, Biora’s GItrac™ autolocation technology enables the device to autonomously identify targeted locations in the GI tract and release a therapeutic dose of up to 500µl.
Biora completion of its Phase 1 SAD/MAD clinical trial to evaluate the safety and PK/PD of BT-600 in healthy volunteers. BT-600 is a drug-device combination consisting of the orally administered NaviCap™ device that delivers a unique, liquid formulation of tofacitinib directly to the colon for the potential treatment of moderate to severe ulcerative colitis. Highlights from the SAD interim results can be found in the . Final SAD/MAD results are expected to be available in late Q2 2024.
About Biora Therapeutics
Biora Therapeutics is reimagining therapeutic delivery. By creating innovative smart pills designed for targeted drug delivery to the GI tract, and systemic, needle-free delivery of biotherapeutics, the company is developing therapies to improve patients’ lives.
Biora is focused on development of two therapeutics platforms: the , which is designed to improve outcomes for patients with inflammatory bowel disease through treatment at the site of disease in the gastrointestinal tract, and the , which is designed to replace injection for better management of chronic diseases through needle-free, oral delivery of large molecules.
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