Healthy volunteer study will evaluate ingestible delivery capsule for oral, needle-free administration of adalimumab with topline data expected by early 2027
SAN DIEGO, Sept. 10, 2026 (GLOBE NEWSWIRE) -- Biora Therapeutics, a biotech company developing BioJet™, a novel, ingestible capsule that uses liquid jet technology to deliver drug into the small intestine for systemic uptake, today announced plans to initiate a first-in-human clinical trial by the end of 2026 evaluating the BioJet capsule for the oral administration of adalimumab.
The planned first-in-human trial is expected to assess safety, tolerability, and pharmacokinetics following administration of adalimumab using the BioJet capsule compared to typical subcutaneous injection in healthy volunteers. The data could support a 2027 regulatory filing for clinical development toward registration.
“Advancing BioJet into a first-in-human study marks a significant milestone for Biora and the future of biologic drug delivery, as we work toward an oral, needle-free option for the millions of patients who receive frequent injections,” said Adi Mohanty, Chief Executive Officer of Biora Therapeutics. “We have made tremendous progress this year scaling our processes and working toward GMP manufacturing. The BioJet program has demonstrated consistent performance across numerous preclinical studies in multiple species, delivering adalimumab at human therapeutic levels, and we look forward to seeing our first human data early next year.”
Biora has an extensive preclinical safety database with over 800 BioJet capsules dosed in multiple large-animal models, including swine, canines, and non-human primates. The BioJet device has been used for oral delivery of a broad range of large-molecule therapeutics, including monoclonal antibodies, peptides, and oligonucleotides.
Adalimumab is among the most widely used biologic therapies and is currently administered by injection. By applying BioJet delivery to adalimumab, Biora aims to demonstrate the platform’s potential to deliver existing biologic formulations orally without needles or complex reformulation. The company believes the BioJet platform could support broader use of biologic therapies by reducing the patient burden associated with injections.
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.
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
