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Feasibility

PROPOSED PATH for non new chemical entity

Three or Four steps, and only the first one needs a decision today

1

Mutual CDA and a scientific session

Sixty minutes with Dr Roger New. Two facts about each candidate molecule — acyl chain, yes or no; GLP-1 receptor moiety, yes or no — classify the entire portfolio against the decision rule and tell us which assets are worth an experiment.

Weeks 0-4

None

2

Rat portal/peripheral feasibility study

The partner supplies API. Formulation in Axcess, intra-intestinal instillation in anaesthetised rats with portal and tail-vein cannulation, i.v. control at one-tenth dose. Measures portal and peripheral bioavailability, confirms or excludes depot behaviour, and returns a measured biopotency for that specific molecule.

Weeks 4-16

Low six figures per molecule

3

Optional Step

Large-animal confirmation and a formulation decision

Juvenile pig study by intra-jejunal capsule — the model closest to human intestinal physiology, blood flow and length. Delivers the dose-ranging data needed to specify a clinical capsule and to decide between an Axcess 6, 9 or 10 product architecture.

Months 4-12

Scoped to assets taken forward

4

Licence and clinical entry

Platform licence on agreed field-of-use terms. Because Axcess makes no chemical modification to the API, the oral product is a new formulation of a known molecule, not a new chemical entity — a materially shorter regulatory path than any conjugation-based oral platform.

Month 4 or 12 onward

Terms to be agreed

The ask today is Step 1 only: a mutual CDA and sixty minutes with Dr Roger New.

Two facts about each molecule

Does it carry an acyl chain? Does it bind a GLP-1 receptor?

Those two answers classify your entire portfolio against the rule and tell us which assets are worth an experiment. Where any are, the next step is a rat portal and peripheral study on API you supply — which replaces every estimate in this deck with a measurement.

Timeline for Completion of Animal Studies (Single and Multi-dose) Prior to Commencement of Human Clinical Trial

Initial human study can be conducted over 6 months with 2 groups of 24 patients each
Escalating dose with placebo control
Administration once weekly
Endpoints: primary – weight change, change in BMI
secondary – glycaemic parameters – HbA1c, FPG changes

Timeline for Completion of Animal Study (Multiple Dose) Prior to Commencement of Human Clinical Trial

Initial human study can be conducted over 6 months with 2 groups of 24 patients each
Escalating dose with placebo control
Administration once weekly
Endpoints: primary – weight change, change in BMI
secondary – glycaemic parameters – HbA1c, FPG changes

Dr Roger New

Co-founder

rn@axcess-tech.com

Glen Travers

Co-founder

gt@axcess-tech.com

Feasibility Process Powerpoint

Open PowerPoint Presentation
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