Company remains on track to initiate clinical study evaluating oral, needle-free delivery of adalimumab in December 2026 with data expected in early 2027
SAN DIEGO, Nov. 04, 2026 (GLOBE NEWSWIRE) -- Biora Therapeutics, a biotech company developing the BioJet™ capsule, a novel, ingestible device that uses liquid jet technology to deliver drug into the small intestine for systemic uptake, today announced that it has received Human Research Ethics Committee (HREC) approval to proceed with its first-in-human clinical study of the BioJet capsule in Australia.
The study is expected to evaluate safety, tolerability, and pharmacokinetics in healthy volunteers following administration of adalimumab, a widely used biologic therapy currently administered by injection. Delivery using the BioJet capsule will be compared with subcutaneous injection.
“Receiving HREC approval keeps us on track with our goal to begin dosing subjects by December,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “The BioJet capsule has the potential to reduce the burden that patients face with chronic self-injections. We look forward to generating clinical evidence for safe, convenient oral delivery of injectable biologic therapies.”
Biora 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.
About Biora Therapeutics
BT Bidco, Inc., dba Biora Therapeutics, is a privately held biotech company developing the BioJet™ capsule, a needle-free delivery platform designed to enable oral dosing of proteins, antibodies, and other biomolecules. 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.
Oral dosing of biomolecules remains a key unmet need for many therapies. 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.
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.
Biora™ and BioJet™ are trademarks of Biora Therapeutics.
For more information, visit bioratherapeutics.com or follow the company on LinkedIn.
Media Contact
media@bioratherapeutics.com
