Biora Therapeutics has positive oral drug delivery device data

Biora Therapeutics shared positive topline results from a trial of its orally administered drug-device combination for treating ulcerative colitis (UC).

BT-600, a proprietary liquid formulation of tofacitinib, is delivered directly to the colon using Biora’s ingestible NaviCap device.

Biora designed NaviCap to improve patient outcomes by enabling therapeutic delivery directly to the site of the disease. This approach increases therapeutic activity in tissue while reducing systemic uptake. Once swallowed, NaviCap’s GItrac autolocation technology helps autonomously identify targeted locations in the GI tract. NaviCap then releases a therapeutic dose of 500µl.

In the Phase 1 clinical trial, 48 healthy volunteers met all trial objectives, Biora said in a news release. It demonstrated drug absorption in colonic tissue that extended to the distal colon, suggesting pan-colonic delivery. All participants tolerated daily dosing of BT-600 well.

“Successful completion of our Phase 1 clinical trial is an important milestone for Biora,” said Dr. Ariella Kelman, chief medical officer. “All study objectives were met, and we confirmed that the NaviCap platform can deliver tofacitinib topically to the colon, with lower peak systemic exposure than with conventional oral delivery. These results support our plan to advance BT-600 into our Phase 1b clinical trial in patients with UC.”

A closer look at the data from Biora

Results from the trial demonstrated a pharmacokinetic profile consistent with drug delivery and absorption in the colon for both single and multiple ascending dose (SAD/MAD) cohorts.

The first evidence of systemic absorption came at six hours, which fell in line with colonic (vs. upper GI) delivery. Maximal levels occurred between 8-10 hours, comparing to 30 minutes for conventional oral tofacitinib in other trials. Biora reported 3-4 times lower maximal systemic drug exposure than conventional oral tofacitinib in other trials. That highlighted NaviCap’s ability to deliver locally to the colon, limiting systemic drug exposure.

Biora said that investigators biopsied sites in the distal colon after drug delivery to the proximal colon for evidence of tissue drug exposure. Biopsy results provided evidence of drug exposure extending to the distal colon at common sites of disease. Post-retrieval device analysis further confirmed that NaviCap devices accurately delivered the drug in the colon, too.

The company reported 100% of devices (SAD cohort) and 98% of devices (MAD) detecting colon entries. Both cohorts reported a well-tolerated NaviCap device.

“We are extremely encouraged by the results from this trial, which demonstrate the NaviCap platform’s ability to deliver drug to the location of disease, where it’s needed,” said Adi Mohanty, CEO of Biora Therapeutics. “Our anatomically targeted approach has the potential to improve the efficacy of JAK inhibitors and other drug classes. We envision a portfolio of NaviCap-delivered therapeutics unlocking new treatment potential for patients with GI diseases.”