AVD-104

The European Clinical Advisory Board brings together top internationally recognized experts to support Aviceda’s novel next-generation treatment paradigm for geographic atrophy secondary to age-related macular degeneration. In addition, Aviceda announces that prior President of the American Society of Retina Specialists, Tarek S. Hassan, MD, will chair the European Clinical Advisory Board. CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Aviceda Therapeutics, a private clinical-stage biotech company focused on developing next-generation immunomodulators by harnessing the power of glycobiology to alleviate chronic, non-resolving inflammation, announced today the formation of its European Clinical Advisory Board (CAB) made up of top internationally recognized thought leaders in retina to provide strategic consultation on the company’s clinical development of its lead asset, AVD-104, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The Company also announced that Tarek S. Hassan, MD will serve as Chair of the European and US CABs. Inaugural members of the European CAB include: Frank Holz, MD Professor and Chair, Department of Ophthalmology, University of Bonn, Germany Co-founder, German Research Foundation Priority Program for AMD & GRADE Reading Center Board of the German Ophthalmological Society Past President, EURETINA Ursula Schmidt-Erfurth, MD Professor and Chair, Department of Ophthalmology and Optometry, Medical University of Vienna, Austria Strategical Head, Vienna Reading Center Jordi Monés, MD, PhD Director, Institut de la Màcula, Barcelona, Spain Director, Principal Investigator and Founder of the Barcelona Macula Foundation: Research for Vision Anat Loewenstein, MD, MHA President, Israeli Ophthalmology Society Vice Dean of the Faculty of Medicine and Sidney Fox Chair of Ophthalmology, Tel Aviv University, Israel Chairman, Ophthalmology Sourasky Medical Center, Tel Aviv, Israel President-elect, EURETINA Usha Chakravarthy, FRCOphth, PhD, CBE Professor of Ophthalmology and Vision Sciences, Royal Victoria Hospital and Queens University of Belfast, Northern Ireland Awarded Commander of the British Empire (CBE) for services to ophthalmology Adnan Tufail, MB, BS, MD, FRCOphth Professor of Ophthalmology, University College London Consultant Ophthalmologist, Medical Retina Service, Moorfields Eye Hospital, London, United Kingdom “We are honored to welcome such outstanding renowned experts in clinical and academic retina to support and guide expansion of our clinical programs with AVD-104 to Europe and across the globe to bring next-generation efficacy and safety to patients with GA secondary to AMD,” said Tarek S. Hassan, M.D., Aviceda’s Chief Development Officer. “We are excited that results from Part 1 of the US Phase 2/3 SIGLEC trial demonstrated functional and anatomic improvement in eyes with GA secondary to AMD after a single injection of AVD-104,” said Mohamed Genead, M.D., Aviceda’s Co-founder and CEO. “With the contributions and support of this esteemed panel—and with Dr. Hassan as its chair—we look forward to bringing our clinical efforts to Europe later this year.” About Aviceda Therapeutics and AVD-104 Aviceda is a clinical-stage biotech company focused on developing novel glyco-immune therapeutics by harnessing the body’s natural immune system to modulate inflammation by using highly selective ligands designed to have maximum specificity towards target immune cells and diseases. Aviceda’s lead clinical-stage ophthalmic candidate, AVD-104, was developed from the Company’s proprietary HALOS™ nanotechnology platform and is under investigation for the treatment of GA secondary to AMD. 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 damaging phagocytic/inflammatory macrophages, resolution of neovascular VEGF-producing macrophages, and repolarization of activated microglia to their neuroprotective resolution state; and 2) inhibition of complement cascade amplification. Topline results from Part 1 of the Company’s Phase 2/3 SIGLEC trial, which is evaluating AVD-104 in patients with GA secondary to AMD, have been released and can be read here. Part 2 of SIGLEC, which is a double-masked, randomized, active comparator trial, is actively enrolling patients, with topline data expected in 2024 and early 2025. Part 2 of SIGLEC will enroll approximately 300 patients across the United States. Learn more about Aviceda Therapeutics. View source version on businesswire.com: Contacts Organization Contact: Aviceda Therapeutics Inc. info@avicedarx.com Source: Aviceda Therapeutics View this news release online at:

Part 2 of the Phase 2/3 SIGLEC clinical trial is designed and powered to serve as the first pivotal trial to support approval of AVD-104 in geographic atrophy. Part 2 of SIGLEC is expected to enroll approximately 300 patients who will be randomly assigned to two arms of AVD-104 or active comparator (avacincaptad pegol) and will be assessed at 12 months. CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Aviceda Therapeutics, a clinical-stage biotech company focused on developing novel glyco-immune therapeutics by harnessing the body’s natural immune system to modulate inflammation by using highly selective ligands designed to have maximum specificity towards target immune cells and diseases, announced today that it has dosed the first patient in Part 2 of the Phase 2/3 SIGLEC trial for AVD-104 in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). “Based on the efficacy and safety we saw in Part 1, we moved rapidly to initiate the Part 2 by activating sites and enrollment for this potentially disease-modifying treatment,” said David Callanan, M.D., Aviceda’s Chief Medical Officer and Senior Vice President. “In Part 1 of SIGLEC, we found that AVD-104 had a positive safety profile, and that patients with GA dosed with AVD-104 showed BCVA improvements at 3 months (Found HERE). We will now further explore outcomes of AVD-104 on GA, this time with the opportunity to compare them to those of a comparator arm.” “Current treatment options for GA address only complement dysregulation,” explained Aviceda Co-founder and CEO Mohamed Genead, M.D. “AVD-104 addresses both macrophage/ microglial-mediated inflammation while also targeting the complement pathway. If this dual-mechanism approach continues to prove to be safe and effective, we may soon see a paradigm shift in how we treat GA.” Part 2 of the SIGLEC trial is a multi-center, double-masked, randomized, controlled trial that will assess safety and efficacy outcomes of AVD-104 and an active comparator (avacincaptad pegol) for the treatment of GA secondary to AMD. Patients will be dosed for 12 months, with the opportunity to remain in the study for an additional 12 months. Those assigned to treatment with AVD-104 will receive either low-dose AVD-104, high-dose AVD-104, or the active comparator. The primary endpoint will be the difference in growth rate of the GA area in patients treated with AVD-104 versus those receiving active comparator at 12 months as measured by fundus autofluorescence. Numerous other visual functional and anatomic efficacy measures will also be explored and compared between AVD-104 and the active comparator. Further information regarding the Phase 2/3 SIGLEC trial can be found HERE. Part 1 of the SIGLEC trial was a multi-center, open-label safety and dose-escalation trial of 30 patients who received a single intravitreal injection of AVD-104 and were followed for 3 months. In Part 1, all patients tolerated a single dose of AVD-104 at month 3, and no drug-related ocular or systemic severe adverse reactions were observed. Read more about the topline data from Part 1 of SIGLEC HERE. About Aviceda Therapeutics and AVD-104 Aviceda is a clinical-stage biotech company focused on developing novel glyco-immune therapeutics by harnessing the body’s natural immune system to modulate inflammation by using highly selective ligands designed to have maximum specificity towards target immune cells and diseases. Our lead clinical-stage ophthalmic candidate, AVD-104, was developed from our proprietary HALOS™ nanotechnology platform, is under investigation for the treatment of GA secondary to age-related macular degeneration (AMD) and diabetic macular edema. 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 damaging phagocytic/inflammatory macrophages, resolution of neovascular VEGF-producing macrophages, and repolarization of activated microglia to their neuroprotective resolution state, and 2) inhibition of complement cascade amplification. Learn more about Aviceda Therapeutics.