AVD-104

CAMBRIDGE, Mass.--( BUSINESS WIRE )-- Aviceda Therapeutics , a private, clinical-stage biotech company focused on developing next-generation immunomodulators with a proprietary HALOS™ nanotechnology platform to alleviate chronic, non-resolving inflammation, announced today that the company completed enrollment of the Phase 2b SIGLEC study that compares the safety and efficacy of AVD-104 versus avacincaptad pegol (Izervay) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). “We would like to thank our investigators and clinical development team for their extraordinary study execution achieving full enrollment the Phase 2b SIGLEC study in record time,” Mohamed Genead, MD, Aviceda’s Co-founder and CEO said. “We see the rapid enrollment as a reflection of the enthusiasm surrounding AVD-104 and its potential to significantly improve outcomes for patients with geographic atrophy.” “The current GA landscape contains a number of unmet needs,” commented David Callanan, MD , Aviceda’s Chief Medical Officer. “Based on our differentiated dual mechanisms of action and strong Phase 2a results, we believe AVD-104 has the potential to meaningfully alter the course of GA progression by enabling tangible functional benefits and neuroprotection of retinal tissue.” SIGLEC is a two-part clinical trial comprised of a Phase 2a and a Phase 2b study. Both studies are being conducted in the United States and are designed to evaluate the safety and efficacy of intravitreally administered AVD-104 in patients with GA secondary to AMD. In Phase 2a, researchers observed no drug-related ocular or systemic serious adverse reactions at 3 months following a single intravitreal injection of AVD-104 and concluded that the drug was well tolerated. Compared with untreated fellow eyes with GA at 3 months, as well as natural history, researchers also found that AVD-104 treatment led to greater reduction in GA lesion progression, improved hyperautofluorescence imaging outcomes in the junctional zone at the border of growing GA lesions, and stabilization or gain of best-corrected visual acuity (BCVA). SIGLEC Phase 2b is a multi-center, double-masked, randomized, controlled trial assessing the safety and efficacy of AVD-104 versus avacincaptad pegol (ACP) for the treatment of GA secondary to AMD. Approximately 300 participants with GA secondary to AMD, BCVA ≥20/320, and GA lesions ranging from 2.5 mm 2 to 17.5 mm 2 in size have been enrolled. Patients with exudative AMD, choroidal neovascularization, or any other ocular condition other than GA were excluded. Patients will be dosed for 12 months, with an opportunity to remain in the study for an additional 12 months. Participants will receive either high-dose AVD-104 every other month, low-dose AVD-104 monthly, or ACP monthly. The primary endpoint is the difference in growth rate of the GA area at 12 months in patients treated with AVD-104 versus those receiving ACP as measured by fundus autofluorescence. Further information regarding Phase 2b of SIGLEC can be found HERE . About Aviceda Therapeutics and AVD-104 Aviceda is a private, clinical stage biotechnology company located in Cambridge, MA, with a proprietary HALOS™ nanotechnology platform and a clinical stage ophthalmic candidate, AVD-104, for the treatment of geographic atrophy secondary to age-related macular degeneration (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 deactivation of inflammatory microglia/macrophages’ phagocytic activity and repolarization of these activated microglia/macrophages to their healing state and 2) inhibition of complement cascade amplification. Along with AVD-104, Aviceda has a broad pipeline of products in development in ophthalmology and multiple other therapeutic areas, including immunology, fibrosis, oncology, and neurology. Learn more about Aviceda Therapeutics .

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: