University of Sydney biotechnology spinout Endo Axiom is conducting its first study in human subjects to assess the safety and tolerability of different doses of oral insulin in healthy volunteers.  

Nicholas Hunt, Associate Professor in the University of Sydney’s Faculty of Medicine and Health, and co-founder and CEO of Endo Axiom said:  

“This Phase 1a clinical study marks Endo Axiom, a spinout from the University, as a clinical- stage company.  

“The first-in-human dosing of 12 participants is the beginning of the careful work required to generate robust evidence in people. The treatment uses enzyme-responsive, liver-targeting nanotechnology." 

Joining forces with Professors Victoria Cogger and David Le Couteur, both from the Faculty of Medicine and Health and the Sydney Local Health District, the researchers focused on developing an oral form of insulin as an alternative to life-saving injections. 

Together with Proto Axiom, a company-creation platform, the group co-founded Endo Axiom Pty Ltd in 2023, a spinout pharma-biotech company, which focuses on developing nanotechnology platforms for the delivery of therapeutic peptides, proteins, antigens and RNA. 

The randomised, double blind, placebo-controlled study is being conducted at CMAX Clinical Research in Adelaide and managed by Datapharm Australia. A phase 1b trial in people with type 1 diabetes will follow. 

“This moment follows more than 20 years of research spanning the University of Sydney, Sydney Local Health District and the ANZAC Research Institute. It reflects years of scientific rigour, manufacturing, regulatory work and clinical execution,” said Professor Cogger, who was this year appointed Executive Director of the Sydney Biomedical Accelerator, a visionary research, innovation and translation partnership between the University, NSW Government and Sydney Local Health District. 

Diabetes is a chronic condition that arises when the pancreas doesn’t produce enough insulin, a hormone that regulates blood sugar levels.  

An estimated nine million people are living with type 1 diabetes globally – while around 13,200 children and young adults under the age of 19 live with type 1 diabetes in Australia. 

For people living with Type 1 diabetes, insulin still requires injection or pump delivery. In addition to the challenges of self-administration, when insulin is injected, it floods the body with the hormone indiscriminately.   

Endo Axiom’s platform is designed to protect the oral insulin as it travels through the gastrointestinal tract and responds to digestion, delivering it to the liver through the route used by the body’s own insulin. 

The research has involved biomedical researchers, clinicians, chemists, physicists and engineers, many from the University of Sydney’s Nano Institute and Charles Perkins Centre.

Australian’s national science agency, CSIRO also developed the insulin encapsulated nanoparticles used for the earliest toxicology studies.

In 2024 Endo Axiom entered a manufacturing agreement with ABINITIO (Ab Initio Pharma Pty Ltd), another University of Sydney spinout, to produce the oral insulin for the clinical trial. 

The University of Sydney actively helps researchers to bring their innovations to market and speeds up their transition from lab to patients through a suite of support packages including mentoring, funding and advice led through the University’s Research Portfolio. 

The Sydney Biomedical Accelerator partnership will fast-track scientific discovery, like Endo Axiom’s oral insulin work, by providing tailored support, state-of-the-art facilities and the industry connections that will enable our teams to respond to clinical need and rapidly translate ideas into patient impact. The Sydney Biomedical Accelerator complex is scheduled for completion in 2028. 

Declaration:

Professor Victoria Cogger, Dr Nicholas Hunt and Professor David Le Couteur are the patent inventors and hold equity in the company Endo Axiom Pty Ltd. The trial has Human Research Ethics Committee approval (Clinical trial number – ACTRN12626000827336). 

Main image: Nicholas Hunt and Victoria Cogger. Credit Stefanie Zingsheim, University of Sydney.