Biora Therapeutics Receives Approval for First-in-Human BioJet Capsule Trial

SAN DIEGO, Nov. 04, 2026 /CourierPR/ -- Biora Therapeutics, a biotech company developing the BioJet™ capsule, has received approval from the Human Research Ethics Committee (HREC) to proceed with its first-in-human clinical study in Australia. This study aims to evaluate the safety, tolerability, and pharmacokinetics of the BioJet capsule in healthy volunteers following the administration of adalimumab, a widely used biologic therapy currently administered by injection.

The BioJet capsule is a novel, ingestible device that uses liquid jet technology to deliver drugs into the small intestine for systemic uptake.

The company has developed an extensive preclinical safety database, with more than 800 BioJet capsules dosed across multiple large-animal models, including swine, canines, and non-human primates. The platform has been evaluated for oral delivery of several classes of large-molecule therapeutics, including monoclonal antibodies, peptides, and oligonucleotides. Adalimumab’s extensive clinical data provide a well-characterized reference for analyzing the first-in-human study results. Biora is using adalimumab to evaluate the BioJet device’s potential to provide systemic delivery of an existing biologic formulation through an oral, needle-free approach.

The BioJet device is an ingestible, single-use device the size of a 00 capsule. It uses Biora’s patented liquid jet technology to deliver biomolecules into the small intestine, aiming to achieve high rates of bioavailability orally and to provide a needle-free alternative for drug delivery. The platform is designed to accommodate existing liquid drug formulations without requiring reformulation. Biora’s comprehensive patent portfolio includes over twenty (20) granted patents with long-dated protection and numerous pending applications, with coverage in all major pharmaceutical markets including the United States, Europe, Japan, and China.

If successful, the BioJet device could help convert injectable therapies into oral dosage forms, increasing patient convenience and offering product differentiation for both pipeline candidates and established brands. By accommodating existing liquid drug formulations, the BioJet capsule offers an alternative delivery option for a broad range of biomolecules, including proteins, peptides, and nucleic acids. The BioJet device is investigational and not approved for commercial use.