“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
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 bioratherapeutics.com/publications.
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
About the NaviCap™ Targeted Oral Delivery Platform
Biora's NaviCap targeted oral therapeutics 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 NaviCap platform uses an ingestible device designed for anatomically targeted, direct delivery of therapeutics 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 recently announced 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 corporate presentation on the company’s website. Final SAD/MAD results are expected to be available in late Q2 2024.
About
Biora is focused on development of two therapeutics platforms: the NaviCap™ targeted oral delivery platform, 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 BioJet™ systemic oral delivery platform, which is designed to replace injection for better management of chronic diseases through needle-free, oral delivery of large molecules.
For more information, visit bioratherapeutics.com or follow the company on LinkedIn or Twitter.
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Investor Contact
Managing Director,
IR@bioratherapeutics.com
(646) 627-8390
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