Eyevensys announces today that it has successfully treated the first patient in a first-in-human phase I/II trial of its lead candidate EYS606 for Non-Infectious Uveitis (NIU). The patient was treated in Paris, France at the Cochin Institute by Professor Antoine Brézin, the principal investigator of the trial, using the company’s novel EyeCET technology.
EYS606 is the first non-viral gene therapy that has the potential to treat NIU patients as replacement of systemic therapy or repeated intra-vitreal injections. EYS606 is based on Eyevensys’ EyeCET technology, which uses a proprietary electro-transfection injection system (ETIS) to deliver a plasmid encoding for the production of an anti-TNFα therapeutic protein into the ciliary muscle of the eye. TNFα is a cytokine that has been shown to play a pivotal role in mediating intraocular inflammation in NIU patients.
The phase I/II trial aims to demonstrate the safety and tolerability of the EYS606 treatment when the plasmid component of EYS606 is administered using EyeCET technology by electro-transfer into the ciliary muscle of patients with non-infectious posterior, intermediate or pan uveitis. The treatment procedure, which takes less than 5 minutes, is designed to provide the patient with a local, safe and sustained treatment, obviating the need for monthly injections. This open-label, multicentre dose escalation study will enrol up to 24 patients in France and the UK and the initial trial results are expected in the first half of 2018.
EYS606 has been granted an Orphan drug designation by the European Medicines Agency (EMA) for the treatment of NIU.
Professor Francine Behar-Cohen, Founder and Chief Scientific Officer of Eyevensys, stated: “Successfully treating our first patient is an important step towards improving outcomes for patients with NIU. This is the first time plasmid DNA has been successfully delivered to the eye via electro-transfection. This represents a major milestone for Eyevensys and a key step in validating the potential of our EyeCET platform to provide safe and long-lasting treatments for patients while avoiding the current standard of multiple injections and their associated safety risks.”
Professor Brézin, Cochin Institute, and principal investigator of the study in France, stated: “I am delighted to be part of this landmark clinical study using Eyevensys’ unique EyeCET platform. This first treatment was very well tolerated by the patient, which represents an important step towards potentially improving outcomes for patients with NIU. NIU is a rare and severe eye condition afflicting approx. 25,000 in France and there is a critical need for novel treatments.”