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 CDO, Tarek Hassan, MD, 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," he said. "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.”