Cambridge, UK-based Exonate has dose the first patient with its lead compound – EXN 407 – in a Phase Ib/II clinical trial investigating the drug in volunteers with centre-involved diabetic macular oedema (CI-DMO).
The clinical trial, launched as part of Exonate’s collaboration with Janssen Pharmacueticals, consists of a dose escalation phase during which three doses of EXN 407 and a placebo will be tested.
This will then be followed by an expansion phase with a larger cohort of patient volunteers and a longer drug dosing period.
The study will aim to demonstrate the safety and efficacy, as well as an exploratory end point of efficacy, through reduction in retinal thickness in a proportion of patients.
“The initiation of our first clinical trial is an important step in the validation of our eye drop approach,” said Catherine Beech, chief executive officer of Exonate.
“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.
“The collaboration with Janssen has been incredibly positive and together, we have designed a study that we believe will deliver meaningful results,” she added.
CI-DMO is caused by an increase of vessel formation on the retina of the eye – current treatments and other retinal diseases require intravitreal injections directly into the eye.
Exonate’s EXN 407, on the other hand, has been designed with ‘sufficient ocular permeability’ so that it can be administered topically as eye drops.
Preclinical studies of EXN 407 have demonstrated an effect on effect on neovascularisation and retinal vascular permeability caused by diabetes without any significant safety or tolerability issues.