Aviceda Announces FDA Clearance of the IND Application Enabling Phase 2 Trials for GA Drug Candidate

Aviceda Therapeutics announced that the 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,” Mohamed Genead, MD, Aviceda’s Co-Founder, President & Chief Executive Officer, said in a company news release. “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 US 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, MD, Chief Medical Officer of Aviceda.