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 enrollment in part 1 of the SIGLEC Phase 2/3 U.S. clinical trial is complete and the Company is preparing to shortly initiate part 2.
Aviceda’s lead candidate, AVD-104, is an engineered glycan (sialic acid) nanoparticle that targets the self-pattern recognition receptors on overly activated retinal immune cells, specifically macrophages and microglia. By repolarizing these immune cells to a resolution state, AVD-104 effectively reduces inflammation. Additionally, it enhances the activity of complement factor H, a crucial regulator of the complement cascade, to better regulate overamplification of the alternative complement cascade.
Mohamed Genead, M.D., Co-founder and CEO said, “We hope that AVD-104’s unique mechanism of action can provide GA patients with a safe treatment that offers improved efficacy compared to existing therapeutic options. We are excited by our data to date and look forward for our larger clinical trial to start next month.”
The SIGLEC U.S. Phase 2/3 U.S. clinical trial is designed to evaluate the safety, pharmacokinetics, and treatment effects of single and multiple doses of intravitreal AVD-104 in participants with geographic atrophy secondary to age-related macular degeneration. Part 1 of the trial is a multi-center, open label safety and dose escalation study that enrolled 30 participants. Patients received a single intravitreal injection of AVD-104 and are being followed for 3 months for safety observation. Part 2 will be a multi-center, double masked, randomized trial to evaluate the treatment effect of AVD-104 against sham and an active comparator. Approximately 290 patients will be randomized across two AVD-104 groups, sham, or active comparator. Patients will receive injections of study drug for 12 months and will have the option to remain in the study for an additional 12 months. The primary endpoint will be the difference in the rate of growth of the GA area between treated participants versus sham at 12 months as measured by fundus autofluorescence. To learn more about the SIGLEC trial, click here.
The full enrollment of all four cohorts in Part 1 was recently announced at The Retina Society annual meeting during a presentation about AVD-104 by David Chow, M.D. Further new and promising positive data from the SIGLEC trial will be presented at the upcoming Eyecelerator session at the American Academy of Ophthalmology meeting in November and other subsequent meetings in the coming months.
“The results we have seen to date are consistent with our initial thesis around AVD-104’s mechanism and provide encouraging signals of efficacy,” said David Callanan, M.D., Aviceda Chief Medical Officer, and Senior Vice President “The study is led by globally renowned experts, and these data are paving the way for the upcoming part 2 SIGLEC U.S. clinical trial, which will begin enrolling in November.”
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 an Investigational New Drug–cleared ophthalmic lead product, AVD-104, for the treatment of geographic atrophy secondary to age-related macular degeneration 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 phagocytic macrophages and repolarization of activated macrophages to their resolution state and 2) inhibition of complement cascade amplification. AVD-104 has demonstrated robust in vitro/vivo efficacy with inhibition of both proinflammatory cellular and complement signaling pathways, and it has the potential for dosing every three months in humans. Outstanding safety has been demonstrated in multiple animal models, including non-human primates, in which no signs of drug-related intraocular inflammation were seen. AVD-104 has also shown significant anti-neovascular activity equivalent to that of aflibercept (Eylea) in a well-established ocular choroidal neovascularization animal model.
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.
