Tyrogenex, Inc. Presents Phase I Study Of X-82 For Wet AMD At The Annual Meeting Of The Association for Research in Vision & Ophthalmology

PALM BEACH GARDENS, Fla.--(BUSINESS WIRE)--Tyrogenex, a privately held company focused on the development of next-generation targeted therapeutics for cancer and ophthalmology, is presenting today preliminary data from its phase 1 safety study of X-82 in patients for wet age-related macular degeneration (AMD) at the 2015 Annual Meeting of the Association for Research in Vision and Ophthalmology in Denver.

“Currently anti-VEGF and anti-PDGF therapies require that injections be performed into the eye, and there is a significant need to alleviate the burden of these frequent injections to both patients and physicians, especially for patients with bilateral disease. We look forward to further study of this orally administered alternative.”

The presentation at 4:45 p.m. MT today by Philip J. Rosenfeld, MD, of the Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, is entitled “A Phase 1 Safety Study of an Orally Available Tyrosine Kinase Inhibitor X-82 in Previously Treated Wet AMD Patients.” The phase 1 study enrolled 35 randomized subjects for a 24-week treatment regimen.

“Preliminary data from this study show that the oral therapy X-82 may offer a strategy for non-invasive delivery of anti-VEGF and anti-PDGF therapies to the eyes of patients with wet AMD,” said Rosenfeld. “Currently anti-VEGF and anti-PDGF therapies require that injections be performed into the eye, and there is a significant need to alleviate the burden of these frequent injections to both patients and physicians, especially for patients with bilateral disease. We look forward to further study of this orally administered alternative.”

X-82 is a dual inhibitor of vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) in development for treatment of wet AMD and solid tumors. Data from this 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.

“Our presentation at ARVO represents an important opportunity to share the promising data from our phase 1 safety study of X-82 with eye and vision researchers from around the world,” said Michael D. Webb, Tyrogenex President and CEO. “We are pleased with the safety and tolerability of X-82 thus far. We’re looking forward to learning more about the difference it may make for patients battling blindness through our phase 2 APEX trial, which is currently enrolling patients.”

About the APEX Trial

APEX is a randomized, double-masked, placebo-controlled, dose-finding phase 2 study being conducted throughout the U.S. at 20 sites and five sites in the U.K. The study is designed to evaluate the safety and efficacy of X-82 in the prevention of vision loss due to wet AMD. APEX is expected to enroll 132 subjects. The primary endpoint of the APEX study is the mean change in visual acuity score from day 1 to 52 weeks after randomization. Another key endpoint is the reduction of the number of injections needed for the duration of the study. Additionally, systemic and ocular safety will be evaluated by assessing ECG, laboratory analyses, adverse events and serious adverse events.

About Wet AMD

AMD is the leading cause of blindness for people over the age of 50 in the United States and Europe. There are two forms of the disease, namely “dry” and “wet” AMD. Wet AMD is characterized by the growth of new blood vessels into the central region of the retina. These new and abnormal blood vessels cause severe central vision loss due to retinal damage caused by leakage of the blood vessels and subsequent scar formation. Anti-VEGF therapies and photodynamic therapies have been approved for wet AMD.

About Tyrogenex

Tyrogenex is developing X-82, as a targeted therapeutic for ophthalmological diseases and solid tumors. Preliminary data from a phase 1/2 pilot study show that X-82 is well tolerated and did not exhibit any dose-limiting toxicity during the study.

For ophthalmology, a phase 1 study showed X-82 was able to maintain or improve vision in all subjects who received the drug for the six-month study duration and most subjects did not require any rescue injections during that time. There were no dose-limiting toxicities encountered during the study.

In oncology, VEGFR tyrosine kinase inhibitors, such as X-82, typically have demonstrated benefit in a variety of cancers though dosage, and use of this class in combination with other therapies, has been limited by side effects. Phase 1 data presented at American Society of Clinical Oncology show that X-82 could a have a significantly lower toxicity profile, which may make it an ideal candidate for combination therapy.

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