Biora Therapeutics to Test BioJet Oral Capsule in First Human Trial

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.

"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

What is the planned trial designed to evaluate?

The planned first-in-human trial will assess safety, tolerability, and pharmacokinetics following administration of adalimumab using the BioJet capsule compared with typical subcutaneous injection in healthy volunteers. Data from the trial could support a 2027 regulatory filing for continued clinical development toward registration.¹ Biora chose adalimumab, among the most widely used biologic therapies and currently administered by injection, to demonstrate BioJet's potential to deliver existing biologic formulations orally without needles or complex reformulation.

What preclinical evidence supports the platform?

Biora has an extensive preclinical safety database, with more than 800 BioJet capsules dosed across multiple large-animal models, including swine, canines, and non-human primates. As of an April 2026 update, the company reported more than 600 devices dosed in large-animal studies with no safety-related issues identified in the ongoing preclinical program.⁴ Biora holds a comprehensive patent portfolio for the platform, with more than 20 granted patents and numerous pending applications covering the United States, Europe, Japan, and China.¹

What are the limitations?

This is a preclinical-to-clinical transition, and no human safety, tolerability, or pharmacokinetic data for BioJet-delivered adalimumab yet exist. BioJet remains investigational and is not approved for commercial use. The trial's topline results, expected by early 2027, are not necessarily guaranteed to support a subsequent regulatory filing.

References

1. Biora Therapeutics. Biora Therapeutics to initiate first human trial of BioJet oral biologic delivery capsule. Press release. Published September 10, 2026. Accessed September 10, 2026. https://www.bioratherapeutics.com/news/biora-therapeutics-to-initiate-first-human-trial-of-biojet-oral-biologic-delivery-capsule
2. Biora Therapeutics. Biora Therapeutics announces improved bioavailability results for its systemic delivery platform. Press release. Published February 16, 2023. Accessed September 10, 2026. https://www.globenewswire.com/news-release/2023/02/16/2609843/0/en/Biora-Therapeutics-Announces-Improved-Bioavailability-Results-for-its-Systemic-Delivery-Platform.html
3. Niazi SK. Oral delivery of biologics: from barrier-limited formulation to active convective transport. Front Drug Deliv. 2026;6:1783113. doi:10.3389/fddev.2026.1783113
4. Biora Therapeutics. Biora Therapeutics advances BioJet swallowable autoinjector. Press release. Published April 8, 2026. Accessed September 10, 2026. https://www.bioratherapeutics.com/news/biora-therapeutics-advances-biojet-swallowable-autoinjector