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Aviceda Announces Successful Completion of Key IND Toxicity Milestone with Favorable Safety Profile in Non-Human Primates

Aviceda Therapeutics has completed a key IND-enabling milestone for its HALOS™ (High-Affinity Ligands of Sigelcs) technology platform by demonstrating a very favorable safety profile at numerous tolerated doses of its lead ophthalmic drug candidate, AVD-104, in non-human primates and rabbits.

The results represent a major step towards first in-human clinical studies for this program - the first potential therapy for patients with geographic atrophy secondary to AMD that addresses the underlying causes of the disease.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aviceda Therapeutics, a private biotech company focused on developing the next generation of immuno-modulators by harnessing the power of glycobiology to modulate the innate immune system and chronic, non-resolving inflammation, announces completion of IND-enabling Good Laboratory Practice (GLP) toxicity studies in two species (total of 80 animals) as agreed upon in discussions with the FDA.

Aviceda has shown positive safety data for multiple well-tolerated doses of its lead drug candidate (known as AVD-104, a novel glycan-coated nanoparticle) from dose-range finding studies in non-human primates (NHPs) and rabbits (80 total animals), to support continued non-clinical development and the initiation of human clinical studies.

Importantly, the results further validate the Company’s technology platform that is utilized throughout Aviceda’s pipeline. The outcome, therefore, has positive read-through implications across each of Aviceda’s therapeutic applications such as fibrosis, neurology, and immunology. Commenting on the result, Aviceda’s Chief Development Officer, Dr. Tarek Hassan observed: “These excellent non-human primate safety study results are exciting to see as we continue the systematic evaluation of our proprietary nanoparticle technology platform to treat very significant blinding eye diseases. Drug development requires a meticulous approach to evaluating and demonstrating solid safety and efficacy data, and we are very encouraged to see our work take this important step toward bringing potential vision-saving therapies to patients in our upcoming first in human clinical evaluations.”

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 dry AMD (dAMD). AVD-104 is an intravitreal molecule with a unique dual mechanism of action for the treatment of GA through its modulation of critical inflammatory & complement pathways. AVD-104 has demonstrated robust in-vitro/vivo efficacy with inhibition of both inflammatory & complement pathways with the potential for up to every 6-month dosing. Superior safety was demonstrated in multiple animal models including non-human primates. GLP-Tox studies were completed in two species which demonstrated excellent safety and 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. Based on the positive outcome of the pre-IND meeting with the FDA, IND submission for initiation of the Phase II trial is planned for 1Q23 with Fast Track Designation.

In addition to AVD-104, Aviceda has a broad pipeline of products in development in ophthalmology and other therapeutic areas such as neurology, fibrosis, and immunology.

Learn more about Aviceda Therapeutics Science.


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Last Updated: 05-Dec-2022