BiOraliX' proprietary technology for oral therapeutic protein dosing

When dosed as bare compounds, MABs and non MAB proteins will not be able to
survive passage of the stomach and hence will not be available for uptake from
the intestinal tract into circulation.

BiOraliX protein formulation technology enables intestinal uptake of MAb's and
non-MAb proteins via oral administration. This nanoparticle formation technology
provides an excellent foundation for protein-optimized formulation composition to
guarantee for the best absorption profile (rate and efficiency of absorption) after
passing the stomach. Once transported from the duodenum to circulation, the
protein is entirely and fully functionally available for its pharmacological activity.

In 3 consecutive preclinical studies with increasing complexity BiOraliX has
demonstrated that the bioavailability of the oral delivery technology, with
omalizumab as test compound, was more than 2 times higher than
SC bioavailability.

Performance summary

Technical performance

  • Demonstrated that structure, binding and functionality are not compromised by manufacturing process (circular dichroism, N-glycans, peptide maps, intact mass, -S-S- bridges, SV-AUC, SPR binding kinetics, potency)
  • Reproducible particle manufacturing (mAb load, particle size distribution)
  • Superior stability
  • Simple process with multiple parameters for optimization of content and PK needs.


In-vivo performance

  • First ever seen data on oral administration of a mAb, very promising and consistent PK from 3 preclinical studies
  • 1 rat study and 2 micropig studies with similar results
  • Orthogonal ELISA results confirm initial ELISA results
  • Linear pharmacokinetics with increasing doses and multiple doses
  • Oral bioavailability 2-3x higher than SC bioavailability
  • Functionality and molecular structure in circulation unchanged after oral intake compared to SC


Feel free to contact us to learn more.