CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aviceda Therapeutics, a privately held, late-stage clinical biotech company focused on developing next-generation immunomodulators by harnessing the power of glycobiology to alleviate chronic non-resolving inflammation, announced today the recent presentation of positive data about AVD-104, its lead ophthalmic clinical asset, at the EURETINA congress held in Amsterdam, Netherlands, from October 4–7, 2023.
The Phase 2/3 SIGLEC trial is currently underway evaluating patients with geographic atrophy secondary to age-related macular degeneration (AMD). Updated data presented at the EURETINA congress showed continued safety of AVD-104, with no drug-related adverse events or serious adverse events thus far at three months in cohorts 1 and 2, two months in cohort 3, and one month in cohort 4. No evidence of any significant dose-limiting toxicity has been observed, locally or systemically. Notably, no drug-related ocular inflammation, retinal vasculitis, choroidal neovascularization, infection, or optic nerve abnormalities were observed in any eyes.
The presentation entitled, “Modulation of Macrophages and Complement Dysfunction in Nonexudative AMD utilizing Novel Sialic-acid Coated Nanoparticles,” was given by Baruch Kuppermann, M.D., 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.
Key Highlights Include:
- Safety Profile – AVD-104, the novel sialic acid–coated nanoparticle, demonstrated an excellent safety profile in an ongoing 9-month repeat-dose toxicology study in non-human primates, with no significant safety signals observed thus far with the three tested doses. All animals tolerated AVD-104 very well indicating its suitability for further development.
- Treatment Efficacy – AVD-104–treated mice 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.
- Clinical Advancement – 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 three months.
“The preclinical results of the safety and efficacy data from animal models provide a strong foundation for human clinical trials,” said David Callanan, M.D., Aviceda’s Chief Medical Officer. “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.”
Additional clinical data will be presented at the upcoming Retina Society annual meeting being held in New York, New York from October 11–14, 2023 as well as at other upcoming scientific meetings.
Key Presentation:
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Thursday, October 12, 2023
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10:01–10:05 a.m. ET, David Chow, M.D.
Modulation of Macrophages and Complement Dysfunction in Geographic Atrophy Utilizing Sialic-acid Coated Nanoparticles
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10:01–10:05 a.m. ET, David Chow, M.D.
To learn more about the SIGLEC trial, click here.
About Aviceda Therapeutics and AVD-104
Aviceda is a private, late-stage clinical biotechnology company located in Cambridge, MA, with a proprietary HALOS™ nanotechnology platform and an Investigational New Drug–cleared ophthalmic lead product, AVD-104, for the treatment of geographic atrophy secondary to age-related macular degeneration. AVD-104 is a promising intravitreal glycan-coated nanoparticle with a dual mechanism of action that modulates critical inflammatory cellular and complement pathways through 1) direct inhibition of the activity of damaging phagocytic macrophages and repolarization of activated macrophages to their resolution state and 2) inhibition of complement cascade amplification. AVD-104 has demonstrated robust in vitro/vivo efficacy with inhibition of both proinflammatory cellular and complement signaling pathways, and it has the potential for every 3- to 6-month dosing in humans. Outstanding safety has been demonstrated in multiple animal models, including non-human primates, in which no signs of intraocular inflammation were seen. AVD-104 has also shown significant anti-neovascular activity equivalent to that of aflibercept (Eylea) in a well-established ocular choroidal neovascularization animal model. The U.S. SIGLEC Phase 2/3 clinical trial is currently actively enrolling for geographic atrophy.
Along with AVD-104, Aviceda has a broad pipeline of products in development in ophthalmology and multiple other therapeutic areas, including neurology, oncology, fibrosis and immunology.
