Biora Therapeutics plans to initiate a first-in-human clinical trial by the end of 2026 evaluating its BioJet oral biologic delivery capsule for administering adalimumab without a needle, the company announced September 10, 2026.¹ The trial will assess safety, tolerability, and pharmacokinetics of adalimumab delivered via BioJet compared with typical subcutaneous injection in healthy volunteers, with topline data expected by early 2027.
Key facts
- Device: BioJet oral biologic delivery capsule (Biora Therapeutics)
- Mechanism: Ingestible capsule; liquid jet delivery into small intestine
- Reference biologic: Adalimumab (widely used anti-inflammatory biologic)
- Trial: First-in-human study; planned to begin by end of 2026
- Endpoints: Safety, tolerability, pharmacokinetics vs subcutaneous injection
- Prior data: 51.3% average bioavailability in porcine preclinical study
- Safety database: 800+ capsules dosed across swine, canine, and NHP models
- Regulatory status: Investigational; data could support 2027 regulatory filing
- IP position: 20+ granted patents; pending applications in US, EU, Japan, China
- Geography: US-based trial and development program
"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, MS, CEO of Biora Therapeutics, in a company press release.¹ "We have made tremendous progress this year scaling our processes and working toward GMP [good manufacturing practice] 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."
How does the BioJet capsule work?
BioJet is an ingestible, single-use capsule about the size of a 00 capsule that uses proprietary liquid jet technology to deliver biologic drugs into the small intestine for systemic uptake, designed to accommodate existing liquid drug formulations without needing needles or complex reformulation. The device has been used to orally deliver a range of large-molecule therapeutics, including monoclonal antibodies, peptides, and oligonucleotides.¹
In earlier preclinical testing of an adalimumab variant delivered via the platform's liquid jet injection technology in a porcine model, Biora reported an average bioavailability of 51.3%, with variability similar to that seen with subcutaneous injection.² This performance sits within the broader landscape of mechanical, force-based oral biologic delivery systems. A peer-reviewed review of the field has noted that the most clinically advanced such device to date achieved 81% relative bioavailability for a full-length antibody compared with subcutaneous injection in an early human trial, suggesting that mechanical bypass of gastrointestinal barriers is achievable in humans.³
Why does needle-free biologic delivery matter?
Oral dosing of biomolecules remains a key unmet need for many therapies, and most approved biologics are administered via injection because of their large molecular size and structural fragility. If successful, Biora says BioJet could help convert injectable therapies into oral dosage forms, increasing patient convenience and offering product differentiation.¹
