Phase 2/3 SIGLEC trial are underway. Data shared at EURETINA 2023 shows continued safety with no drug-related adverse events thus far in cohorts 1, 2, 3, and 4.
Aviceda Therapeutics shared positive data regarding AVD-104 at the 2023 EURETINA congress held in Amsterdam, Netherlands.
The company’s Phase 2/3 SIGLEC trial evaluating patients with geographic atrophy secondary to age-related macular degeneration (AMD) is ongoing, but updated data was presented at the EURETINA congress showing the continued safety of AVD-104. Importantly, there have been no drug-related adverse events or serious adverse events thus far at 3 months in cohorts 1 and 2, 2 months in cohort 3, and 1 month in cohort 4. There is also no evidence of any significant dose-limiting toxicity having been observed, locally, or systemically. They also report that no drug-related ocular inflammation, retinal vasculitis, choroidal neovascularization, infection, or optic nerve abnormalities were observed in any eyes.1
This information was shared by Baruch Kuppermann, MD, Chair of the Department of Ophthalmology at University of California Irvine, Director of the Gavin Herbert Eye Institute, and the Roger F. Steinert Endowed Chair in Ophthalmology during his EURETINA presentation entitled, “Modulation of Macrophages and Complement Dysfunction in Nonexudative AMD utilizing Novel Sialic-acid Coated Nanoparticles.”
Of note during this presentation, the safety profile of AVD-104, which is the novel sialic acid–coated nanoparticle being evaluated, demonstrated an excellent safety profile in an ongoing 9-month repeat-dose toxicology study in non-human primates. No significant safety signals have been observed thus far with the 3 tested doses. All animals tolerated AVD-104 very well indicating its suitability for further development.1
Mice treated with AVD-104 experienced a significant reduction in outer nuclear layer thickness attenuation on day 7 following bright light severe retinal degeneration compared to control eyes. Treatment also reduced choroidal neovascular (CNV) lesion sizes comparable to aflibercept in a laser induced CNV mouse model.1
No dose-limiting toxicity or drug-related adverse events were reported in any eyes during Part 1 of the US Phase 2/3 SIGLEC clinical trial for AVD-104 at 3 months.1
In the press release, David Callanan, MD, Aviceda’s Chief Medical Officer shared his excitement for AVD-104 and the expected timeline for additional news regarding the trials and treatment of this particle saying, “The preclinical results of the safety and efficacy data from animal models provide a strong foundation for human clinical trials,” said “We are eager for the continuation of parts 1 and 2 of the US Phase 2/3 SIGLEC clinical trial for patients with AMD-related geographic atrophy. Initial data is coming in from part 1 and part 2 is scheduled to commence by the end of 2023.”