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

Aviceda Therapeutics announced 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.

Cambridge, Massachusetts-based Aviceda, has developed a proprietary nano-technology HALOS platform and an IND-ready ophthalmic lead product for geographic atrophy (GA) secondary to dry AMD (AMD). 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. 

Aviceda has shown positive safety data for multiple well-tolerated doses of its lead drug candidate 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 nonclinical 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.

“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," Aviceda’s Chief Development Officer, Dr. Tarek Hassan, said in a company news release. "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.”