Aviceda Announces Successful Submission of an Investigational New Drug (IND) and Fast Track Designation (FTD) Application for AVD-104 for the Treatment of Geographic Atrophy Associated with Age-Related Macular Degeneration (AMD)

Aviceda Therapeutics has completed a key regulatory milestone for its HALOS™ (High-Affinity Ligands of Sigelcs) technology platform and its lead ophthalmic drug candidate, AVD-104, a novel intravitreal glyco-conjugated nanoparticle.

This represents a major step towards initiation of Phase 2 human clinical studies for this program - the first potential therapy for patients with geographic atrophy (GA) secondary to AMD that addresses the underlying causes of the disease.

Aviceda submitted a Fast Track Designation application as suggested by the FDA.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aviceda Therapeutics, a private biotech company focused on developing the next generation immuno-modulators by harnessing the power of glycobiology to modulate the innate immune system and alleviate chronic, non-resolving inflammation, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The IND supports the use of its lead intravitreal ocular asset, AVD-104 (a novel glycan-coated nanoparticle), for the treatment of GA secondary to AMD, the most common blinding eye disease in those over 65 years of age. Aviceda previously announced the successful completion of IND-enabling Good Laboratory Practice (GLP) toxicity studies that showed positive safety data for multiple well-tolerated doses of AVD-104. This included dose-range finding studies in non-human primates (NHPs) and rabbits (80 total animals), to support continued development and the initiation of human clinical trials.

“With only one currently approved therapy for the treatment of GA, there is still a significant unmet medical need for patients with this condition. This IND application brings us a step closer to bringing a new and differentiated treatment option for disease modification of the key underlying pathobiology of AMD via the modulation of immune and complement dysfunction,” said Mohamed Genead, MD, Co-Founder, CEO & President of Aviceda.

David Callanan, MD, Aviceda’s Chief Medical Officer, said, “As a retina specialist and ocular immunologist, I am excited about advancing AVD-104 into the clinical phase as we believe that this novel ocular nanoparticle-based therapy will be key in the treatment of this devastating blinding eye disease with enhanced efficacy, safety, and prolonged durability. We anticipate beginning our Phase 2 trial as soon as possible after FDA review. This key milestone advances our technology to the clinical phase, and further validates the Company’s platform, which includes assets to be directed at neuro-inflammation/degeneration, oncology, fibrosis, and other rare immune pathologies.”

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

Aviceda is a private biotechnology company located in Cambridge, MA with a proprietary nano-technology HALOS™ platform and an IND-ready ophthalmic lead product for geographic atrophy (GA) secondary to 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, by directly inhibiting the activity of damaging phagocytic macrophages and repolarizing them to their resolution state, and by inhibiting the amplification of the complement cascade. AVD-104 has demonstrated robust in-vitro/vivo efficacy with inhibition of both inflammatory & complement pathways with the potential for every 4- 6-month dosing. Superior safety was demonstrated in multiple animal models including non-human primates with no signs of any intra-ocular inflammation. In addition, AVD-104 has demonstrated equivalent prevention of neovascularization compared to aflibercept (Eylea) in a well-established ocular CNV model. In addition to AVD-104, Aviceda has a broad pipeline of products in development in ophthalmology and other therapeutic areas such as neurology, oncology, fibrosis, and immunology.

Learn more about Aviceda Therapeutics Science.

PR: info@avicedarx.com

Mohamed Genead, MD: mgenead@avicedarx.com ; David Callanan, MD: dcallanan@avicedarx.com