Clinical trials investigate treatment for diabetic eye disease

A new approach to treating one of the leading causes of blindness among patients with diabetes is being tested in clinical trials which begin this month.

The trial involves 48 patient volunteers with diabetic macular oedema (DMO), a disease where blood vessels leak fluid into the retina. It is the most common cause of vision loss among people with diabetic retinopathy, affecting approximately 21 million people worldwide.

As part of a randomised multicentre trial, the patients, who are in treatment at retinal centres in Australia, will be given either a placebo or a dose of EXN 407, the lead chemical compound in the drops, created by Exonate, an mRNA therapy company focused on retinal diseases.

The clinical trial is the culmination of an extensive period of research, which involved academics from the University of Bristol in its early stages, including Professor Dave Bates, formerly of Bristol’s School of Physiology and Pharmacology, now at the University of Nottingham.

“We are delighted to see the discoveries made by so many people over the last 15 years being used to treat patients for the first time,” said Professor Bates. “To be part of medical research from the lab bench all the way through to the clinic is a rare privilege.

“This has been an immense team effort -from the first identification of SRPK1 as a target at the University of Bristol with Steve Harper, Lucy Donaldson and colleagues, to the impact of novel chemistry from Jonathan Morris at UNSW, and his team, through the proof of concept using these novel inhibitors in pre-clinical models at the University of Nottingham, to the development of the pre-clinical and clinical programmes by the Exonate team, our contractors and collaborators. A great many scientists have contributed along the way – we thank everyone involved.”

This first phase of trials will involve escalating the dosages given to the 48 patient volunteers. That will be followed by an expansion phase with a larger cohort of patient volunteers and a longer drug dosing period.

The study aims to demonstrate safety and tolerability of EXN 407 by examining its effects in reducing the retinal thickness that is caused by DMO. Current treatments for DMO require intravitreal injections directly into the eye, whereas EXN 407 has been designed with sufficient ocular permeability to be given topically as eye drops.

To date, Australia has managed the COVID-19 pandemic such that no major delays are expected in patient recruitment and initial results are anticipated in early 2022.

Dr Catherine Beech, Chief Executive Officer of Exonate, said: “The initiation of our first clinical trial is an important step in the validation of our eye drop approach. This is a unique opportunity to create a drug that may have the potential to improve the treatment of patients with retinal vascular diseases and transform the lives of those suffering from vision loss.”

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