Tyrogenex announces results from phase 1 study of orally-administered X-82 in patients with AMD

Nov 15 2015

Tyrogenex, a privately held company focused on the development of targeted therapeutics for cancer and ophthalmology, today announced data from its phase 1 open-label study of orally-administered X-82 in patients for wet age-related macular degeneration (AMD). The data was presented today during the American Academy of Ophthalmology Annual Meeting 2015 in Las Vegas, NV.

Dr. Nauman Chaudhry, a partner at New England Retina Associates in Connecticut, presented final-results of the phase 1 trial. Dr. Chaudhry has authored more than 90 papers and abstracts in peer-reviewed ophthalmology journals.

"This shows a great new potential, which can decrease the number of injections and may change people's lives," said Dr. Chaudhry.

X-82 is an orally administered, dual inhibitor of vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) in development for treatment of wet AMD and advanced solid tumors. Data from the phase 1 study support the recently initiated phase 2 study referred to as "APEX" for wet AMD in Previously treated Eylea patients with X-82.

The open-label dose-escalating phase 1 study tested X-82 in 35 adult patients with wet AMD to evaluate safety and preliminary efficacy. Six treatment regimens at four dose levels of X-82 was evaluated. The outcomes showed an overall trend toward higher visual acuity of +4.3 letters of the Early Treatment Diabetic Retinopathy Study chart, and a trend toward decreased foveal thickness of -48 µm at 24 weeks (average of all patient data up to injection or dropout). Of the 25 patients completing 24-weeks on X-82, 15 required no intravitreal injections of anti-VEGF and had a mean visual acuity improvement of +5.3 letters. X-82 was generally well tolerated, with 25 of 35 patients completing the full 24-week treatment period.