ROCKVILLE, Md.--(BUSINESS WIRE)--Tyrogenex, a privately held biopharmaceutical company, today announced the completion of patient enrollment in the APEX Study – a phase 2 trial of X-82 (vorolanib) for the oral treatment of wet age-related macular degeneration (wAMD).
The APEX study is a randomized, double-masked, placebo-controlled, dose-finding, non-inferiority study of X-82 plus as-needed intravitreal anti-VEGF compared to as-needed intravitreal anti-VEGF alone in patients with neovascular AMD. Subjects are being treated for a total of 52 weeks with one of three doses of X-82 or placebo (ClinicalTrials.gov # NCT02348359).
"Completion of patient enrollment in this phase 2 study is a significant milestone in our X-82 development program," stated Eric I. Richman, Chief Executive Officer of Tyrogenex. "We believe that X-82 has the potential to transform the management of wAMD with its oral delivery method.”
"We are grateful for the commitment and enthusiasm of the Scientific Advisory Board and the participating clinical investigators," stated Daniel Salazar Ph.D., SVP, Development and Director of Tyrogenex. "In addition to exceeding our initial enrollment target of 132 patients by 25 patients, we are encouraged that the Data Safety Monitoring Board has met three times so far and supported continuing the study unchanged.”
X-82 is an investigational orally administered inhibitor of the vascular endothelial growth factor receptor (VEGFR) and platelet derived growth factor receptor (PDGFR). The binding of X-82 to these receptors may lead to efficacy in angiogenic diseases such as wet age-related macular degeneration (wAMD). X-82 is being evaluated in a Phase 2 clinical trial (APEX Study) for use in combination with anti-VEGF drugs that represent the current standard of care for the treatment of wAMD. The Company has completed one Phase 1 trial in patients previously treated with Lucentis® (ranibizumab), Eylea® (aflibercept) and Avastin® (bevacizumab) and in naïve patients. The Company is also investigating the potential of X-82 for oncology indications.
Tyrogenex is a biopharmaceutical company focused on improving the lives of patients with wet Age-related Macular Degeneration and solid tumors by discovering medicines to help provide additional treatment options. Tyrogenex’s lead compound is X-82. For more information, visit www.tyrogenex.com.
This press release contains forward-looking statements that are based on company management’s current beliefs and expectations and are subject to currently unknown information, risks and circumstances and actual results may vary from what is being currently projected.