The NaviCap targeted oral delivery platform, is an ingestible device approximately the size of a fish oil pill. Credit: Andrea Danti via Shutterstock.

Therapies within the ulcerative colitis (UC) space are ever-evolving for the improvement of local, targeted therapy. UC is a chronic inflammatory bowel disease of the gastrointestinal (GI) tract, presenting with issues such as diarrhoea, blood in the stool, fatigue, loss of appetite and weight loss. The etiology of IBD is not fully known, but indications point to a mixture of both genetic predisposition and environmental factors accelerating the growth in the number of IBD cases.

Therapies for the treatment of UC include anti-inflammatory drugs and immunosuppressants, but newer therapies have turned towards the use of monoclonal antibodies (mAbs) for more effective treatment in maintaining remission and reducing relapse of UC. Therapies for UC target pro-inflammatory markers that are elevated in the GI tract of UC patients. Some common targets include Janus kinase, tumour necrosis factors, integrins and interleukins.

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One of the greatest barriers in drug delivery is being able to increase the therapeutics level in the tissue at the specific target site while reducing the systemic intake of the therapeutic safely. Of the 49 marketed drugs approved for UC, many offer less than ideal efficacy due to issues related to safety and toxicity in the affected tissues.


Biotechnology company Biora Therapeutics recently announced the initiation of its Phase I clinical study of BT-600 in healthy human volunteers. BT-600 is a novel medical drug-device combination that aims to deliver tofacitinib, the active ingredient in Pfizer’s Xeljanz, directly to the colon, in a new approach of targeted, topical drug delivery.

BT-600 will be delivered by the NaviCap targeted oral delivery platform, an oral, ingestible device 26mm by 11mm – approximately the size of a fish oil pill. Once the smart pill is ingested, Biora’s auto-location technology will allow the device to identify the target location through the GI tract’s anatomy rather than physiology, and effectively release the therapeutic dose of up to 500ul locally, rather than systemically.

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While it is still early days for Biora’s new smart pill, it represents a potentially new treatment modality that may increase the efficacy of therapeutics in the specified tissue. For that reason, the clinical trial data for this drug-device combination will be one to keep an eye on.

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