The clearance of the Investigational New Drug Application will allow the company to initiate Phase 2 trials of the drug for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Aviceda Therapeutics announced the U.S. Food and Drug Administration has cleared the Investigational New Drug (IND) Application for AVD-104. This will enable the company to proceed with initiating Phase 2 clinical trials of AVD-104 for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
According to a news release from the company1, 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.
David Callanan, MD, Chief Medical Officer of Aviceda, elaborated on the significance of the treatment in the release.
“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 Callanan.
According to the company, AVD-104 has demonstrated robust in-vitro/vivo efficacy with inhibition of both inflammatory and complement pathways and the potential for every 4-6 month dosing. In addition, AVD-104 has demonstrated anti-neovascular activity equivalent to that of aflibercept (Eylea) in a well-established ocular CNV model.
“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, MD, Aviceda’s Co-Founder, President and 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.”
According to the company, Phase 2 clinical trial is expected to begin in Q2 of 2023.