CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aviceda Therapeutics, a private clinical-stage biotech company focused on developing next-generation immunomodulators by harnessing the power of glycobiology to alleviate chronic, non-resolving inflammation, announced today that they have enrolled the first patient in the GLYCO Phase 2 U.S. clinical trial evaluating their lead ophthalmic candidate AVD-104 for the management of diabetic macular edema (DME). AVD-104 is an engineered glycan (sialic acid) nanoparticle that reduces inflammation by targeting the self-pattern recognition receptors on overly activated retinal neutrophils, macrophages, and microglia, and repolarizing them to their resolution state.
Ashkan Abbey, M.D., of Texas Retina Associates said, “I am honored to dose AVD-104 in the first patient in the GLYCO trial to evaluate its potentially next-generation dual mechanism of action to reduce the chronic inflammation that drives many cases of DME.”
Mohamed Genead, M.D., Aviceda’s Co-founder and CEO said, “We are excited to evaluate the ability of AVD-104’s unique mechanism of action to provide DME patients with a safe treatment that may improve outcomes in eyes with DME driven by inflammatory and VEGF-mediated mechanisms.”
“AVD-104 down-regulates neutrophils and has been shown to reduce the release of inflammatory cytokines,” explained David Callanan, M.D., Aviceda’s Chief Medical Officer and Senior Vice President. “There is still a need for improvement in the treatment of DME and we believe it may offer therapeutic advantages in the management of DME, and potentially in diabetic ischemia.”
The GLYCO Phase 2 U.S. clinical trial will evaluate the safety and treatment effects of intravitreal AVD-104 in patients with DME. This multi-center, open-label safety and tolerability study will enroll 30 patients to evaluate a low and high dose of AVD-104 with 3-month follow-up. The primary endpoint will be the incidence and severity of ocular and systemic adverse events. Secondary endpoint analyses will include standard evaluations of treatment efficacy, including macular thickness and vision. Further exploratory variables will include the potential effect of AVD-104 on macular ischemia.
Further information regarding the GLYCO trial can be found HERE.
About Aviceda Therapeutics and AVD-104
Aviceda is a private, late-stage clinical biotechnology company located in Cambridge, MA, with a proprietary HALOS™ nanotechnology platform and a clinical stage ophthalmic candidate, AVD-104, for the treatment of geographic atrophy secondary to age-related macular degeneration (AMD) and diabetic macular edema. AVD-104 is a promising intravitreal glycan-coated nanoparticle with a dual mechanism of action that modulates critical inflammatory cellular and complement pathways through 1) direct inhibition of the activity of damaging neutrophils and phagocytic macrophages and repolarization of activated macrophages to their resolution state and 2) inhibition of complement cascade amplification. AVD-104 has completed dosing in the single ascending dose Part I of the company’s Phase 2/3 SIGLEC trial, which is evaluating patients with geographic atrophy secondary to AMD. Topline three-month data from Part I is expected in early 2024 along with the initiation of Part II, which is a double-masked, randomized, active comparator trial. Part II of the Phase 2/3 trial will enroll 300 patients across U.S. clinical sites.
Along with AVD-104, Aviceda has a broad pipeline of products in development in ophthalmology and multiple other therapeutic areas, including oncology, immunology, neurology, and fibrosis.
