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Results of human device function studies for the NaviCap™ Targeted Oral Delivery Platform in healthy volunteers and patients with UC

Four clinical device performance studies evaluated the functionality and safety of the NaviCap device in healthy participants and patients with active UC.

Despite progress in the treatment of patients with ulcerative colitis (UC), outcomes remain sub-optimal. Research has shown that insufficient drug concentration in colon tissue is a potential cause of low remission rates.1,2,3

The NaviCap™ platform is an orally ingestible smart pill equipped with Biora’s proprietary GITrac™ localization technology that identifies anatomic locations in the gastrointestinal (GI) tract. In the current platform application, the NaviCap device is designed to deliver a liquid drug formulation directly to the colon mucosa, bypassing the upper GI tract. This has the potential to improve efficacy and reduce systemic toxicity by achieving high tissue and low systemic drug concentrations. Results from four human device function clinical studies of the NaviCap without drug are presented in this poster.

What did we find?

The NaviCap device was well-tolerated in 81 administrations to 47 participants, across four human studies.

There was no clear evidence of food effects on device performance.

The NaviCap device released 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.4

Poster presented at at Digestive Disease Week, May 18 – 21, 2024

View the Poster

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REFERENCES

  1. Verstockt B, Alsoud D, van Oostrom J, et al. Poster presented at: 17th Congress of the European Crohn’s and Colitis Organisation (ECCO), February 18, 2022, virtual.
  2. Yarur AJ, Jain A, Sussman DA, et al. The association of tissue anti-TNF drug levels with serological and endoscopic disease activity in inflammatory bowel disease: the ATLAS study. Gut. 2016;65(2):249-255.
  3. Pauwels RWM, Proietti E, van der Woude CJ, et al. Vedolizumab Tissue Concentration Correlates to Mucosal Inflammation and Objective Treatment Response in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2021;27(11):1813-1820. doi:10.1093/ibd/izab053
  4. Lee SN, Razag G, Kelly C, et al. Results of human device function studies for the NaviCap™ Targeted Oral Delivery Platform in healthy volunteers and patients with UC. Poster presented at: Digestive Disease Week, May 18 – 21, 2024, Washington DC.