Take-home: ALG-1001 (Luminate, Allegro Ophthalmics) has a number of different mechanisms of action that benefit patients chronically treated with anti-vascular endothelial growth factor drugs and those who are treatment naïve.
ALG-1001 (Luminate, Allegro Ophthalmics), a first-in-class integrin peptide therapy, met the primary endpoint of vision non-inferiority to bevacizumab (Avastin, Genentech Inc.), an anti-vascular endothelial growth factor therapy (anti-VEGF), with 12-week durability in a population of patients with mostly chronic diabetic macular edema (DME).
ALG-1001 seems to be a strong player with different mechanisms of action that benefit patients who have been receiving chronic anti-VEGF therapy and those who are treatment naïve.
In the DEL MAR Phase IIb stage 2 clinical trial, ALG-1001 was evaluated as a sequential therapy or used in combination with bevacizumab in 80 patients with DME. ALG-1001 works by affecting multiple angiogenic pathways, according to David Boyer, MD.
In previous studies of the drug, ALG-1001 exhibited a strong track record with a few mechanisms of activity. A study sponsored by the manufacturer showed that ALG-1001 binds to the retinal pigment epithelium for several months.
In another sponsored study from Johns Hopkins University, ALG-1001 appeared to have 4 times more anti-angiogenic activity compared with aflibercept (Eylea, Regeneron Pharmaceuticals) in a murine model of retinopathy of prematurity. Another study from Johns Hopkins University also showed that ALG-1001 reduced vascular leakage. Other investigations have shown that the formulation affects only stressed retinal cells and has an anti-inflammatory effect, Dr. Boyer pointed out.
“These multiple mechanisms of action appear to reset the retina back to its normal balance by turning off the machinery of angiogenesis,” he added. “This is different from anti-VEGF therapy.”
Dr. Boyer is clinical professor ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles.