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Development of preclinical models to assess the performance of the oral biotherapeutic delivery system (OBDS) capsule

After determining animal models to use for our systemic therapeutics platform, we evaluated device performance in a canine model and assessed pharmacokinetics in a swine model.

Oral delivery of biologics, peptides, and nucleic acids has proven difficult due to the harsh conditions of the upper gastrointestinal tract and poor absorption in the small intestine. The current state of-the-art technology for a successful oral protein delivery provides around 1% bioavailability when delivered as an oral tablet.1

We aim to develop an oral biotherapeutic delivery system (OBDS) that prevents drug degradation in the upper gastrointestinal tract and increases bioavailability via liquid jet delivery to the small intestine.

In these preclinical studies, our objectives were to evaluate the in vivo performance of the OBDS device using:

  1. Oral delivery in a canine model to evaluate autonomous trigger function.
  2. Endoscopic delivery in a swine model to demonstrate potential submucosal injection efficiency for human translation.

What did we find?

In canines, we demonstrated ≥ 83% deployment accuracy of autonomous OBDS devices and consistent deployment time post gastric emptying in the small intestine, with no early deployment.

In swine, eight animals showed detectable drug levels with an oral bioavailability average of 22% (range from 7-55%).

We demonstrated that PGN-OB1 can achieve as high as 55% bioavailability of a variant of adalimumab in swine, which is a magnitude greater than current oral protein or peptide delivery technology in the market, and at levels much closer to the subcutaneous route of administration estimated in human trials.2

Poster presented at the 2022 Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference, October 18-19, 2022

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REFERENCES

  1. Overgaard RV, Navarria A, Ingwersen SH, Bækdal TA, Kildemoes RJ. Clinical Pharmacokinetics of Oral Semaglutide: Analyses of Data from Clinical Pharmacology Trials. Clin Pharmacokinet. 2021;60(10):1335-1348.
  2. Lee SN, Stork C, Smith J, et al. Development of a submucosal injection device for an oral biotherapeutic delivery system. Poster presented at: Parenteral Drug Association Universe of Pre-Filled Syringes and Injection Devices Conference, October 18-19, 2022, Palm Springs, CA.