Systemic Therapeutics

Oral delivery of biotherapeutics designed to improve disease management

Our Systemic Therapeutics program uses an ingestible smart capsule for needle-free, oral delivery of biotherapeutics, with the potential to deliver a broad range of large molecules including monoclonal antibodies, peptides, and nucleic acids. These substances cannot survive stomach acids and are too large to be absorbed in the intestine and are therefore currently delivered by injection. 

With more frequent administration, oral delivery has the potential to improve drug efficacy and safety profiles compared to current injection regimens. 

Needles are associated with poor disease management

38% of diabetics miss 4+ injections per week.1

71% higher discontinuation rate for diabetes patients initiating treatment with an injectable GLP-1 agonist vs. those starting oral therapy.2 

42% of patients fail to maintain diabetes treatment due to injection concerns when using an injectable GLP-1 agonist.2

How the Oral Biologic Delivery System (OBDS) works

  • ORAL CAPSULE: Convenient oral capsule the size of a multivitamin for ease of swallowing
  • PRECISE DELIVERY: Enteric trigger for precise timing of drug delivery to the small intestine
  • NEEDLE-FREE ADMINISTRATION: Liquid jet injection to the small intestine to maximize systemic uptake
 
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Therapeutic challenges

Large molecules cannot achieve systemic uptake through intestinal absorption.

Needle-based therapy leads to poor disease management due to inconsistent dosing.

Other oral delivery technologies require difficult re-formulation and lengthy approval pathways.

Biora’s oral delivery approach

Proprietary liquid jet delivery directly into intestinal tissue enhances systemic uptake.

More frequent and consistent administration vs. injection may improve patient outcomes.

Use of liquid formulation means the OBDS can deliver a range of approved large molecules, without reformulation.

Systemic delivery of biotherapeutics through oral administration

We are developing a pipeline of investigational drug/device combinations that are designed for oral delivery of biotherapeutics. Our proprietary liquid jet delivery is designed to increase systemic uptake and bioavailability of large molecules.   

While advancing our own pipeline, we have also partnered with Ionis Pharmaceuticals to evaluate the OBDS for delivery of antisense oligonucleotides, and we have agreements with two other leading pharmaceutical companies to evaluate delivery of their proprietary drugs via the platform. 

Program Indication Design / Feasibility Preclinical Clinical

OBDS
Device

Preclinical

PGN-OB2
GLP-1 agonist + Device

Diabetes
Preclinical

PGN-OB1
Adalimumab variant + Device

Autoimmune
Preclinical

Ionis Collaboration
Antisense therapy + Device

Undisclosed
Design/Feasibility

Large Pharma 1 Collaboration
Undisclosed drug + Device

Undisclosed
Design/Feasibility

Large Pharma 2 Collaboration
Undisclosed drug + Device

Undisclosed
Design/Feasibility
  • PGN-OB1
  • PGN-OB2

PGN-OB1: liquid formulation of anti-TNF-alpha monoclonal antibody delivered with the OBDS for the treatment of autoimmune conditions

We are developing PGN-OB1 as a combination product of a variant of adalimumab and the OBDS for the treatment of inflammatory conditions. Several anti-TNF-alpha antibodies have been approved to treat a range of inflammatory conditions. However, all require either intravenous or subcutaneous injection. Adalimumab is approved for a range of inflammatory disorders and is the best-selling drug globally. An oral variant of adalimumab presents a significant opportunity for the many patients who would like to avoid painful injections. 

PGN-OB1 is currently in preclinical stage development with a formulation that we have developed and scaled to GMP grade material.

PGN-OB2: liquid formulation of a GLP-1 receptor agonist delivered with the OBDS for the treatment of Type 2 diabetes

We are developing PGN-OB2 as a combination product of a GLP-1 receptor agonist and the OBDS for the treatment of Type 2 diabetes. GLP-1RAs are a leading class of therapeutics for type 2 diabetes. We believe oral GLP-1RAs will be preferred by patients to injectables, resulting in a significant market opportunity. 

We are currently advancing development of PGN-OB2 with key preclinical studies. As a result of our use of known molecules, we believe that rapid proof of concept with preclinical and phase 1 pharmacokinetic results is possible. 

References

  1. Frost & Sullivan research commissioned by Rani Therapeutics Holdings, Inc. https://ir.ranitherapeutics.com/static-files/b1f080bf-a860-4136-87cb-d6f7c49c1502
  2. Spain CV, Wright JJ, Hahn RM, Wivel A, Martin AA. Self-reported Barriers to Adherence and Persistence to Treatment With Injectable Medications for Type 2 Diabetes. Clin Ther. 2016;38(7):1653-1664.e1.