Oral Biotherapeutics

Drug-device combinations using Progenity's novel Drug Delivery System (in development)


Oral, needle-free delivery of large molecules has the potential to improve drug efficacy and safety through improved dosing regimens.

Oral delivery of large molecules

Woman about to take a pill with a glass of water.

Biologic drugs have become standard of care for a variety of diseases, including rheumatoid arthritis, psoriasis, diabetes, Crohn’s disease, ulcerative colitis, and many cancers.

Until now, oral delivery of monoclonal antibodies and other biologics has been elusive. At Progenity, we’re developing a pipeline of orally delivered large molecules using a novel oral delivery system. This needle-free system requires no injections and has the potential to deliver a large range of molecules, including monoclonal antibodies, peptides, and nucleic acids. With more frequent oral administration, oral delivery has the potential to result in more constant drug levels and therefore improved efficacy and safety compared to injection.

The clinical dilemma

Currently, large molecule-based therapies are delivered by injection because they are not readily absorbed in the GI tract. However, these injections can be both difficult and expensive, creating barriers to patient compliance. Both providers and patients prefer oral medications over injections.

Our solution

Progenity’s oral biopharmaceutical delivery system (OBDS) is designed to enable convenient, needle-free systemic delivery of large-molecule biologics. Our unique capsule:

  • Protects the drug from degradation in the upper GI tract
  • Delivers a liquid formulation of the drug directly to the small intestine for optimal systemic uptake
  • Enables oral, needle-free drug delivery with no injections
3D render of the Progenity OBDS.

Drug–device combination product candidates

At Progenity, we are developing drug-device combination products using proprietary liquid formulations of widely prescribed drugs and our oral biopharmaceutical delivery system (OBDS). Our formulations are optimized for systemic uptake with delivery by the OBDS. Currently, we have two oral biotherapeutics in development:
PGN-OB1
Adalimumab + OBDS
PGN-OB2
GLP-1 agonist + OBDS

Oral adalimumab delivered with OBDS

PGN-OB1 contains a liquid, high-concentration formulation of adalimumab owned and developed by Progenity. It is currently in preclinical evaluation.

Benefits include:

  • Needle-free delivery with the OBDS
  • Oral formulation to avoid injection and drive adoption
  • Potential to improve efficacy and safety
  • Drug substance scaled to GMP clinical material

Oral liraglutide delivered with OBDS

PGN-OB2 contains a liquid, high-concentration formulation of liraglutide owned and developed by Progenity. It is currently in preclinical evaluation.

Benefits include:

  • Needle-free delivery with the OBDS
  • Potential for no fasting or food restrictions before ingestion
  • Potential for pursuit of a bioequivalence 505(b)(2) path that could alleviate the requirement for phase III efficacy and a cardiovascular outcomes trial, facilitating potential commercial launch in 2025

Key Data

Robust preclinical data across multiple molecule classes in animal models
Up to 29% bioavailability observed preclinically to date

Clinical Development Roadmap

2021

  • Initiated preclinical studies of fully autonomous integrated device

2022

  • Initiation of first clinical study evaluating pharmacokinetics of a therapeutic delivered with the OBDS

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