Diabetology’s Breakthrough Clinical Data From Oraglutide™ Oral GLP-1

Diabetology Limited (Jersey) poster presentation (https://diabetology.co.uk/ada-poster) 1724-P at the ADA 86th Scientific Session, New Orleans, reporting first human data from Oraglutide™ — small capsule intestinally-released oral semaglutide, formulated using the proprietary Axcess™ delivery technology.

KEY HIGHLIGHTS

• 6-day glucose control: A single 4 mg oral dose of Oraglutide™ produced a sustained fall in glucose. Measuring 14% at Day 6 (p=.046), the longest duration presented from a single oral GLP-1 dose in a human IVGTT study.
• 28% increase in insulin secretion: Relative to placebo, insulin percent AUC increased by 12% day 0, (p=0.02) & 28% Day 1 (p = 0.025).
• Novel intestinal depot effect: Blood levels of semaglutide were higher on Day 1 than dosing on Day 0, consistent with lipid associated depot effect in the intestinal wall, a fundamentally new pharmacological finding.
• No nausea or side effects observed: No adverse events observed across the 8-subject cohort over one week, consistent with targeting vagal afferent mechanisms that avoids peak off target outer circulation exposures.
• Dose >6x lower than Rybelsus: Biopotency at least six-fold greater than Rybelsus (R2) opens the door to Oraglutide™ low dose, long acting and Satietyde™ microdose maintenance & rebound prevention formulations
• Circulating Blood Levels sufficient to trigger pancreatic GLP-1 receptors observed to Day 4
• Platform patent cover to 2044: Diabetology's licensed Axcess™ formulation technology is protected by patents and applications extending to 2044.

Oraglutide’s™ possibility of optimal compliance from the convenience of a once weekly oral capsule follows the well-established once weekly GLP-1 injection regimen.

The longer action and lower side effect profile emerges from the considerably lower oral dosing and more physiological pathway of delivery via the intestine wall. This is where most GLP-1 is naturally produced and vagal nerve receptors exist to trigger satiety via the brain. These advantages could significantly reduce overall costs of therapy, allow less dropouts and side-effects and opens the possibility of Satietyde™ microdosing to reduce rebound effects following obesity treatments.

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