Australia-based Endo Axiom Pty Ltd has dosed its first human participants with an oral nanoparticle-encapsulated insulin formulation, marking the company's transition to clinical stage after extensive preclinical development. The Phase Ia study is enrolling 12 healthy volunteers in a randomised, double-blind, placebo-controlled design to assess safety and tolerability across multiple doses. The trial is being conducted at CMAX Clinical Research in Adelaide and managed by Datapharm Australia (trial number ACTRN12626000827336). A Phase Ib study in people with type 1 diabetes (T1D) is planned to follow.
The formulation uses enzyme-responsive, liver-targeting nanoparticles designed to protect insulin from degradation as it transits the gastrointestinal (GI) tract, releasing the hormone into the portal circulation — the route taken by endogenously secreted pancreatic insulin. The nanoparticle technology was co-developed with Australia's national science agency, CSIRO, for early toxicology studies, and is manufactured for the clinical programme by Ab Initio Pharma Pty Ltd (ABINITIO), a separate University of Sydney spinout. Endo Axiom was founded in 2023 by Associate Professor Nicholas Hunt, Professor Victoria Cogger, and Professor David Le Couteur, all from the University of Sydney and Sydney Local Health District, together with company-creation platform Proto Axiom.
Oral insulin has been a longstanding drug-delivery challenge because the peptide is readily degraded by gastric acid and proteolytic enzymes and has poor intestinal permeability. Endo Axiom's approach is designed to overcome those barriers while restoring hepatic-first-pass exposure, which could more closely reproduce normal insulin physiology than subcutaneous administration.
The enzyme-responsive nanoparticle design is intended to trigger insulin release in the digestive environment without requiring active targeting ligands. Whether the platform can achieve sufficient and reproducible systemic exposure remains to be established; the current Phase Ia study is focused primarily on safety and tolerability rather than glycemic efficacy.
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