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.
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.
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
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
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.
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.
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 |
|---|---|---|---|---|
NaviCap™ |
— | |||
BT-600 |
Ulcerative Colitis | |||
BT-001 |
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.
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.
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