BIONDD® oral capsule delivers liraglutide with 119% bioavailability comparable to SC injection in dogs

Biomacromolecules, including peptides, proteins, and antibodies, are crucial therapeutics for various diseases. However, their primary administration route is via injection, which is often inconvenient and can lead to poor patient adherence. There is a significant unmet need for effective oral delivery systems for biologics to improve patient quality of life and expand therapeutic accessibility. This study addresses this gap by developing the BIONDD® technology, an oral device designed to deliver large therapeutic molecules directly into the gastric wall, bypassing the typical barriers to oral absorption.

Researchers developed the BIONDD® technology, an oral administration device housed within a standard 00 or 0-sized capsule. Upon ingestion, the device actuates in the stomach, delivering the biomacromolecule from a spike into the gastric wall, facilitating its migration to blood vessels. To validate this system, 0.4 mg liraglutide was used as a model peptide. The BIONDD® capsule was orally administered to dogs, and its pharmacokinetic profile was compared against subcutaneous (SC) administration of liraglutide. Primary endpoints included Tmax (time to maximum concentration) and relative oral bioavailability.

The BIONDD® oral capsule successfully delivered 0.4 mg liraglutide in dogs, demonstrating a pharmacokinetic profile highly comparable to subcutaneous injection. A key finding was the achievement of a short Tmax following oral administration, indicating rapid absorption. Most notably, the relative oral bioavailability of liraglutide delivered via the BIONDD® capsule was found to be 119% when compared to subcutaneous administration. This result significantly surpasses typical oral bioavailability for peptides, which is often negligible. The study's large animal data provides robust proof-of-concept for the BIONDD® technology as a viable and convenient oral delivery system for a broad range of biologics. This innovative approach overcomes significant challenges in peptide absorption.

The BIONDD® oral capsule achieved a relative oral bioavailability of 119% for 0.4 mg liraglutide compared to subcutaneous administration in dogs.