US-based Tyrogenex has started a Phase II trial (Apex) of its orally administered drug candidate, X-82, for the treatment of wet age-related macular degeneration (AMD) in previously treated Eylea patients.
X-82 is a dual inhibitor of vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) being developed to treat wet AMD and solid tumours.
Preliminary data from a Phase I/II pilot trial showed that X-82 is well tolerated and did not exhibit any dose-limiting toxicity.
Tyrogenex president and CEO Michael Webb said: "The launch of Apex represents an exciting step for Tyrogenex as we build on positive safety and tolerability data for X-82, which inhibits pathologic blood vessel growth — an important factor in the treatment of wet AMD.
"Current treatments for wet AMD require injections into the eye, and we believe an oral treatment, like X-82, may make a significant difference for patients who are battling blindness and for whom regular visits to the physician’s office are challenging."
The randomised, double-masked, placebo-controlled, dose-finding Phase II trial is being carried out throughout the US at 20 sites and five sites in the UK.
Around 132 patients are expected to be enrolled in the trial, which is designed to evaluate the safety and efficacy of X-82 in the prevention of vision loss due to wet AMD.
The trial’s primary endpoint is the mean change in visual acuity score from day 1 to 52 weeks after randomisation, while another key endpoint is the reduction of the number of injections needed for the duration of the study.
In addition, systemic and ocular safety will be evaluated by assessing ECG, laboratory analyses, adverse events and serious adverse events.
Image: Super resolution microscopic investigation of human eye tissue affected by AMD. Photo: courtesy of Andy Nestl.