[June 01, 2023]

Aviceda Announces Dosing of First Patient With AVD-104, a Novel Glyco-Mimetic Nanoparticle for the Treatment of Geographic Atrophy from Macular Degeneration, in the Phase 2 SIGLEC Trial

Aviceda Therapeutics, a private clinical-stage biotech company focused on developing next generation immuno-modulators by harnessing the power of glycobiology to alleviate chronic, non-resolving inflammation, announced the dosing of its first patient with AVD-104 in its Phase 2 SIGLEC Trial today by Ashkan Abbey, MD of Texas Retina Associates in Dallas. This lead intravitreal asset is a novel glycan-coated nanoparticle, supported by a uniquely strong pre-clinical in vivo efficacy and safety profile, used for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). "I am honored to be the first to dose a new agent that we hope will usher in a generation of safe treatments for GA with better outcomes than were ever possible before," said Dr. Abbey.

"AVD-104 is a potentially transformative targeted approach for patients with GA due to AMD," said David Callanan, M.D., Chief Medical Officer of Aviceda. "AVD-104 attacks two fundamental processes in GA by modulating critical inflammatory pathways through the inhibition of retinal macrophage inflammatory activity and repolarization of activated macrophages to their resolution states, and, through inhibition of complement cascade amplification. Based on this dual mechanism and the exquisite selectivity and preclinical potency of AVD-104, we believe it could provide a profound benefit for patients in dire need of new therapies. We have designed our Phase 2 trial to move efficiently through dose escalation and to increase the chances of seeing early signals of clinical activity."

Tarek Hassan, M.D., Aviceda' s Chief Development Officer commented, "I am thrilled to get to the clinic with this first-in-class new drug, and its powerful mechanisms of action that focus on converting activated macrophages to their resolution states, as well as inhibiting complement activation, to safely achieve he next level of efficacy in treating GA from AMD. Soon we look to be able to modulate the inflammatory activity of most immune cells with our HALOS™ (High-Affinity Ligands of Siglecs) platform technology and thereby specifically target other therapeutic areas with unmet needs in immunology, fibrosis, neurology, and others."

Visit https://www.clinicaltrials.gov/ (NCT05839041) to learn more about the SIGLEC trial.

About AMD

Age-related macular degeneration (AMD) is a major cause of moderate and severe vision loss in adults over 60 worldwide, currently affecting approximately 11 million people in the United States. Central vision can be prominently, and permanently, reduced such that affected patients can lose their independence and become limited in many basic functions including reading, driving, and recognizing faces. The wet, or neovascular, form of AMD occurs because of abnormal blood vessel growth, bleeding, and scarring that destroys central retinal cells. Approved anti-VEGF therapies have helped control and treat this form. The dry, or non-neovascular, form of AMD is characterized by the development of geographic atrophy (GA) in which there is irreversible progressive destruction of central retinal cells and underlying blood vessels due to chronic inflammation (with over-activated macrophage activity with resultant phagocytosis of retinal and RPE cells) and abnormal complement activation in the retinal photoreceptor, retinal pigment epithelial, and choriocapillaris regions in the back of the eye. Current therapeutics are under development to treat dry AMD by reducing chronic inflammation and inhibiting elements of the complement cascade.

About Aviceda Therapeutics and AVD-104

Aviceda is a private clinical-stage biotechnology company located in Cambridge, MA, with a proprietary HALOS™ nanotechnology platform and an IND-cleared ophthalmic lead product for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). AVD-104 is an intravitreal nanoparticle molecule with a unique dual mechanism of action for the treatment of GA through its modulation of critical inflammatory pathways: 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 inflammatory & complement pathways and the potential for every 3- to 6-month dosing. Outstanding safety has been demonstrated in multiple animal models, including non-human primates, in which no signs of intraocular inflammation were seen. In addition, AVD-104 has demonstrated anti-neovascular activity equivalent to that of aflibercept (Eylea) in a well-established ocular CNV model. SIGLEC Phase 2/3 clinical trial is currently enrolling for GA.

Along with AVD-104, Aviceda has a broad pipeline of products in development in ophthalmology and multiple other therapeutic areas, including neurology, oncology, fibrosis, and immunology.

Learn more about Aviceda Therapeutics.

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