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BT-600 is an orally administered drug-device combination developed for the potential treatment of moderate to severe ulcerative colitis. It utilizes Biora Therapeutics’ NaviCap ingestible device to deliver a proprietary liquid formulation of tofacitinib directly and locally to the colon. This targeted delivery aims to increase colonic tissue exposure while reducing systemic absorption, potentially improving efficacy and minimizing adverse events associated with systemic exposure. Phase 1 clinical trials in healthy volunteers demonstrated that BT-600 achieves delayed, pan-colonic delivery of tofacitinib, with first evidence of systemic absorption at six hours post-administration (compared to 30 minutes for conventional oral formulations), maximal levels at eight to ten hours, and three-to-four times lower maximal systemic drug exposure than standard oral dosing[1][4][6][9]. The device performed as intended in nearly all participants, confirming effective localized delivery[8].
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