Tyrogenex Initiates the APEX study, a Phase 2 Trial of Oral Treatment with X-82 for Wet AMD
PALM BEACH GARDENS, Fla.--(BUSINESS WIRE)--Tyrogenex, a privately held company focused on the development of next-generation targeted therapeutics for cancer and ophthalmology, today announced the initiation of a phase 2 study referred to as “APEX,” for wet AMD in Previously treated Eylea patients with X-82.
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 age-related macular degeneration (AMD) and solid tumors. Preliminary data show that X-82 does not exhibit dose-limiting toxicity.
"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,” said Michael D. Webb, Tyrogenex President and CEO. “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.”
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.
For additional information relating to the APEX study, visit clinicaltrials.gov.
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.
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.