There have been 9 Axcess generations and refinements over 20 years of research and clinical exposure resulting in the safe and commercially viable unique oral capsule formulations for Capsulin and Oraglutide. The latest evolution utilising Axcess 9 and the benefits of AI involves targeting neural receptors in the gut via the vagal nerve triggering physiological responses in the brain which transmit messages to and from the vital organs.
This new era of neuro pharmaceuticals is advancing with many options of utilising the vagal nerve signalling pathways to and from the brain to assist patient responses in a wide range of disfunctions.
Yes. The ability of Axcess to deliver a peptide orally is unrelated to the natures of the peptide itself, so a wide range of peptides and proteins can be incorporated into the Axcess formulation and administered as capsules. As can be seen in the table below, peptides differing in molecular weight, charge, hydrophilicity etc have all been worked on either in a preclinical or a clinical setting.
The distribution seen in the body will depend on the receptors which the peptides is targeting. In the case of insulin, the peptide passes via the portal vein into the liver, where receptors bind to most of the peptide before it can pass into the outer circulation. As a result, blood levels of insulin in the peripheral bloodstream are maintained at low levels when delivered in Capsulin, which is the ideal situation.
In contrast, peptides for which receptors are not present in the liver will pass straight though the liver into the outer circulation, resulting in high concentrations in the bloodstream. A good example of this is exenatide, a GLP-1 receptor agonist. Receptors for GLP-1 are not found in the liver, and in Diabetology’s rodent studies an apparent bioavailability close to 20% is seen in the portal vein, and ~10% in the outer circulation [New 2024]. In addition to oral insulin, Diabetology is focussing on delivery of GLP-1 receptor agonists (GLP-1 RAs) in the Axcess formulation, and is generating data in preclinical and clinical studies with its “Oraglutide” formulation, containing peptides such as semaglutide and others.
Diabetology has already demonstrated that it is possible to put two peptides into the same formulation [New 2024] – namely insulin and a GLP-1 receptor agonist (exenatide) – and this capability can be applied across the board to the whole range of peptides which can assist and synergise with each other in the area of diabetes and obesity, as a result of co-administration in one capsule, to enhance activity of these peptides beyond what is currently achievable.
Oral Capsule Technology for Insulin, GLP-1 and Other Protein-Based Therapies and Combinations.
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Figure 3: Demonstration of versatility of Axcess in terms of peptides which
can be delivered
