Aviceda Announces FDA Clearance of the Investigational New Drug (IND) Application for AVD-104, a Novel Glyco-Mimetic Nanoparticle, Enabling Initiation of Phase 2 Clinical Trials for the Treatment of Geographic Atrophy from Macular Degeneration

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aviceda Therapeutics, a private clinical-stage biotech company focused on developing 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 the U.S. Food and Drug Administration (FDA) has cleared the IND for AVD-104, enabling the company to proceed with initiating Phase 2 clinical trials of its lead intravitreal ocular asset for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The Phase 2 SIGLEC trial is expected to begin in Q2 2023.

“The FDA’s acceptance of our IND application to initiate the clinical evaluation of AVD-104 brings us one step closer to introducing a potentially paradigm-shifting treatment for people living with geographic atrophy and macular degeneration,” said Mohamed Genead, M.D., Aviceda’s Co-Founder, President & Chief Executive Officer. “The AVD-104 IND clearance marks an important milestone for Aviceda as we continue our track record of execution as the leader in the glycome field. We are thrilled to advance the development of AVD-104 in the U.S. and are working to rapidly enroll patients in the Phase 2 portion of the study. We look forward to presenting additional data later this year.”

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 via inhibition of the activity of retinal macrophages and repolarization of activated macrophages to their resolution state coupled with inhibition of complement cascade amplification.

“I am very excited to bring the power of our glyco-biology based technology platform to address the significant unmet medical needs in patients with macular degeneration. As a practicing vitreoretinal specialist, I saw firsthand the devastating effect of this disease on my patients. This is the first step in bringing a novel and differentiated therapy to these patients,” said David Callanan, M.D., Chief Medical Officer of Aviceda.

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 nano-technology HALOS™ 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 4-6-month dosing. Outstanding safety has been demonstrated in multiple animal models, including non-human primates, in which no signs of intra-ocular 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. Phase 2 clinical trial is expected to begin in Q2 of 2023.

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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