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Article History

Received: 13 June 2025

Accepted: 16 September 2025

First Online: 19 January 2026

Declarations

:

: This study was carried out in accordance with the ethical standards and protocols approved by the local ethics committee. Written informed consent was obtained from all participants before being included in the study.

: The authors confirm that the Principal Investigator for this paper is Ofer M. Gonen, MD, PhD, FRACP and had direct clinical responsibility for patients.

: All authors, except Ofer Gonen and Andrew Blauvelt, were employees of the company at the time the work was conducted. Dr. Blauvelt has served as a speaker (received honoraria) for Eli Lilly and Company, UCB, and Almirall, has served as a scientific adviser (received honoraria) for AbbVie, Almirall, Alumis, Amgen, Anaptysbio, Apogee, Arcutis, Astria, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Corvus, Dermavant, Eli Lilly and Company, Galderma, GlaxoSmithKline, Immunovant, Incyte, IQVIA, Janssen, Leo, Lipidio, Merck, Novartis, Oruka, Paragon, Pfizer, Rani Therapeutics, Regeneron, Sanofi, Spherix Global Insights, Sun Pharma, Syncona, Takeda, UCB, Union, and Zai Lab, has acted as a clinical study investigator (institution has received clinical study funds) for AbbVie, Acelyrin, Almirall, Alumis, Amgen, Arcutis, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Eli Lilly and Company, Galderma, Incyte, Janssen, Leo, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, Takeda, and UCB, and owns stock in Lipidio and Oruka.

: Therapeutic antibodies, such as ustekinumab, cannot be taken orally due to rapid degradation by digestive enzymes. Formulation strategies, such as encapsulation and targeted delivery, are under development to overcome these barriers to oral delivery of antibodies.

: This study shows that a novel, orally ingestible robotic pill (RP) can protect an antibody from digestion and auto-deploy in the small intestine, delivering the biologic as a painless transenteric injection with high reliability and bioavailability, similar to a subcutaneous (SC) injection. PK simulations project that a more frequent (oral) dosing regimen will maintain steady state therapeutic exposures within a narrow range, potentially minimizing adverse effects and improving therapeutic outcomes, unlike the high peak-to-trough variability in circulating drug levels typically observed with typical SC injection dosing intervals.