Enrollment in SIGLEC Phase 2/3 US clinical trial is complete, Aviceda Therapeutics to initiate part 2

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Enrollment in part 1 of the SIGLEC Phase 2/3 US clinical trial is complete, and Aviceda Therapeutics is preparing to initiate part 2.

According to the company, AVD-104 is an engineered glycan (sialic acid) nanoparticle designed to target the self-pattern recognition receptors on overly activated retinal immune cells, specifically macrophages and microglia. By repolarizing these immune cells to a resolution state, AVD-104 can reduce inflammation. The compound also enhances the activity of complement factor H, which is a crucial regulator of the complement cascade. This can allow for better regulation of overamplification of the alternative complement cascade.

Mohamed Genead, MD, Co-founder and CEO of Aviceda Therapeutics shared his hopes for AVD-104 in the press release, saying, “We hope that AVD-104’s unique mechanism of action can provide GA patients with a safe treatment that offers improved efficacy compared to existing therapeutic options. We are excited by our data to date and look forward for our larger clinical trial to start next month.”

The SIGLEC U.S. Phase 2/3 US clinical trial is designed to evaluate the safety, pharmacokinetics, and treatment effects of single and multiple doses of intravitreal AVD-104 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

In part 1 of the trial,30 participants are enrolled in a multi-center, open label safety and dose escalation study. These patients received a single intravitreal injection of AVD-104 and will be followed for 3 months for safety observation.

Part 2 will be a multi-center, double masked, randomized trial to evaluate the treatment effect of AVD-104 against sham and an active comparator. There will be approximately 290 patients randomized across 2 AVD-104 groups, sham, or active comparator. These patients will receive injections of study drug for 12 months and will have the option to remain in the study for an additional 12 months. The primary endpoint will be the difference in the rate of growth of the GA area between treated participants versus sham at 12 months as measured by fundus autofluorescence.

The full enrollment of all four cohorts in Part 1 was recently announced at The Retina Society annual meeting during a presentation about AVD-104 by David Chow, MD. Further new and promising positive data from the SIGLEC trial will be presented at the Eyecelerator session at the American Academy of Ophthalmology meeting in November.

David Callanan, MD, Aviceda Chief Medical Officer, and Senior Vice President noted the results of the trial so far. He said, “The results we have seen to date are consistent with our initial thesis around AVD-104’s mechanism and provide encouraging signals of efficacy. The study is led by globally renowned experts, and these data are paving the way for the upcoming part 2 SIGLEC U.S. clinical trial, which will begin enrolling in November.”

Reference:

1. Aviceda Completes Enrollment in Part 1 of the SIGLEC Phase 2/3 U.S. Clinical Trial; Initiation of Part 2 Imminent. Aviceda Therapeutics. October 23, 2023. Accessed October 23, 2023. https://www.businesswire.com/news/home/20231023793898/en/Aviceda-Completes-Enrollment-in-Part-1-of-the-SIGLEC-Phase-23-U.S.-Clinical-Trial-Initiation-of-Part-2-Imminent