NaviCap™ Targeted Oral Delivery Platform

Targeted oral delivery to the GI tract designed to improve patient outcomes

Our NaviCap targeted oral delivery platform (formerly the Drug Delivery System or DDS) uses an ingestible smart capsule designed for delivery of therapeutics to the large intestine to improve the treatment of inflammatory bowel disease (IBD), with an initial focus on ulcerative colitis.

Delivering therapeutics directly to the site of disease in the gastrointestinal tract could enable safer and more effective drug therapies for patients.

About ulcerative colitis

Inflammatory bowel disease includes Crohn’s disease and ulcerative colitis (UC).

About 1 million people in the U.S. are affected with UC, and ~40,000 new cases are diagnosed each year.1

UC causes inflammation and damage to the large intestine.

Video: how the NaviCap platform works

  • ORAL ADMINISTRATION: Convenient oral capsule the size of a fish-oil pill
  • AUTONOMOUS LOCATION: Our GITrac™ autolocation technology enables targeted delivery to the colon, regardless of fasted or fed state2
  • TARGETED DRUG DELIVERY: Method designed to coat the length of the colon with liquid formulation, minimizing systemic uptake
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Therapeutic challenges for UC

Difficulty of achieving sufficient drug levels at site of disease

Systemic toxicity issues may limit daily dosage of UC drugs

Combination therapy is limited by toxicity

NaviCap targeted delivery approach

Increased drug levels in tissue at the site of disease are correlated with improved outcomes3

Less systemic uptake may lead to reduced toxicity and fewer adverse events

Reduced toxicity could enable combination therapy4

Device function confirmed using scintigraphic imaging

Biora has conducted device function studies in both healthy volunteers and patients with active ulcerative colitis, with more than 40 study participants receiving over 70 NaviCap devices to date. During several studies, NaviCap devices filled with a saline solution that included radioisotopes were swallowed by healthy volunteers. Scintigraphic imaging was then used to visualize device localization and payload delivery to the lower GI tract.

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Biora’s BT-603 device performance study was designed to evaluate the safety and tolerability and localization and delivery function of the phase 1-ready NaviCap device in healthy volunteers. Scintigraphic images for a single subject dosed during the study are shown in this video.

NaviCap Targeted Therapeutics Pipeline

We are developing a pipeline of investigational drug/device combinations designed to overcome the limitations of current treatments for ulcerative colitis. 

Program Indication Design / Feasibility Preclinical Clinical

Targeted Oral Delivery Platform


NaviCap + tofacitinib

Ulcerative Colitis

NaviCap + adalimumab variant

Ulcerative Colitis
  • BT-600
  • BT-001

BT-600: Liquid formulation of tofacitinib delivered via the NaviCap platform for the treatment of ulcerative colitis

We are developing BT-600 (formerly PGN-600) as an orally delivered liquid formulation of tofacitinib for the treatment of ulcerative colitis. Tofacitinib is approved for ulcerative colitis and is dose limited based on safety concerns, making it an ideal therapy for targeted delivery. 

Our preclinical data demonstrates that targeted delivery using BT-600 can lead to reduced drug levels in blood and to increased levels in tissue at least 25 times higher along the length of the colon versus the equivalent standard oral dose. 

If we demonstrate similar results clinically to what has been observed preclinically, and given the known efficacy of the currently approved doses of tofacitinib, we believe BT-600 has the potential to greatly improve patient outcomes in ulcerative colitis.

BT-600 is currently in preclinical stage development.

BT-001: Liquid formulation of Anti-TNF-alpha monoclonal antibody delivered via the NaviCap platform for the treatment of ulcerative colitis

We are developing BT-001 (formerly PGN-001) as an orally-delivered variant of adalimumab for the treatment of ulcerative colitis (UC). Multiple anti-TNF-alpha targeting therapies have been approved for UC, but data suggests patients may not have enough drug in the tissue to engage the target, TNF-alpha, and reduce inflammation. We have developed our own anti-TNF-alpha antibody formulation for use in further development.

BT-001 is currently in preclinical stage development. We have conducted a series of preclinical studies demonstrating the potential of locally delivered anti-TNF-alpha antibodies to reduce disease burden in UC models.  


  1. Shivashankar R, Tremaine WJ, Harmsen WS, Loftus EV Jr. Incidence and Prevalence of Crohn’s Disease and Ulcerative Colitis in Olmsted County, Minnesota From 1970 Through 2010. Clin Gastroenterol Hepatol. 2017;15(6):857-863.
  2. Lee SN, Razag G, Stork C, et al. Potential effects of food on a novel Drug Delivery System (DDS) to deliver therapeutic compound into the colon. Poster presented at: Crohn’s & Colitis Congress, January 19-21, 2023, Denver, CO.
  3. Verstockt B, Alsoud D, van Oostrom J, et al. Tofacitinib tissue exposure correlates with endoscopic outcome. Oral presentation at the 34th edition of the Belgian Week of Gastroenterology, February 9, 2022. 
  4. Van Oostrom J, Hanzel J, Verstockt B, et al. Pharmacokinetic stratification of cytokine profiles during anti-TNF induction treatment in moderate-to-severe ulcerative colitis. Poster presented at the 17th Congress of the European Crohn’s and Colitis Organisation (ECCO); February 18, 2022.