Company Updates

Aviceda Therapeutics Completes Enrollment of Phase 2b SIGLEC Study Assessing the Safety and Efficacy of AVD-104 for Geographic Atrophy Secondary to AMD

The Phase 2b SIGLEC study comparing the safety and efficacy of three GA treatments—high-dose AVD-104, low-dose AVD-104, and avacincaptad pegol—has enrolled approximately 100 patients in each study arm.

Aviceda Therapeutics Announces Addition of Erin Lavelle to Board of Directors

Erin Lavelle, former Chief Operating Officer and Chief Financial Officer of ProfoundBio, brings extensive financial and operational biotechnology experience and expertise

Aviceda Therapeutics Announces Formation of Renowned European Clinical Advisory Board

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.

Aviceda Therapeutics Announces First Patient Dosed in Part 2 of the Phase 2/3 SIGLEC Clinical Trial Assessing AVD-104 for the Treatment of Geographic Atrophy

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.

Aviceda Therapeutics Announces Topline Data from Part 1 of the Phase 2/3 SIGLEC Clinical Trial for AVD-104, Demonstrating Positive Safety and Early Clinical Efficacy in Patients with Geographic Atrophy

AVD-104 was well-tolerated in all patients, with no drug-related ocular or systemic serious adverse events detected.

Substantial slowing of GA lesion growth was observed, and a majority of study subjects showed functional improvement that was sustained at 3 months after a single injection of AVD-104.

Data supports the initiation of Part 2 of the Phase 2/3 SIGLEC trial, an active-comparator study that may serve as a first pivotal trial to support the approval of AVD-104 in geographic atrophy

Aviceda Announces First Patient Enrolled in Phase 2 GLYCO Clinical Trial Evaluating AVD-104 for the Treatment of Diabetic Macular Edema

AVD-104 is an engineered glycan (sialic acid) nanoparticle that reduces inflammation by targeting the self-pattern recognition receptors on overly activated retinal neutrophils, macrophages, and microglia, and repolarizing them to their resolution state.

Aviceda is advancing the development of AVD-104, a Novel Glyco-Mimetic Nanoparticle, for the treatment of Diabetic Macular Edema as an indication expansion in addition to Geographic Atrophy (lead indication); AVD-104 is currently enrolling patients with GA in the SIGLEC Phase 2/3 Trial.

A multi-center, multi-dose, open-label safety and tolerability study will enroll 30 patients to evaluate a low and high dose of AVD-104, with topline results expected in Q2 2024.

Aviceda Completes Enrollment in Part 1 of the SIGLEC Phase 2/3 U.S. Clinical Trial; Initiation of Part 2 Imminent

Advancing the Development of AVD-104, a Novel Glyco-Mimetic Nanoparticle for the Treatment of Geographic Atrophy from Macular Degeneration

Aviceda Announces AVD-104, a Novel Glycomimetic Nanoparticle, Demonstrates Continued Clinical Safety in the Treatment of Geographic Atrophy Secondary to Macular Degeneration

Positive Data Presented at Recent European Congress; Additional Forthcoming Data to be Presented at US Healthcare Conference.

Aviceda To Present at Major European Healthcare Conferences Highlighting AVD-104, a Novel Glyco-Mimetic Nanoparticle for the Treatment of Geographic Atrophy from Macular Degeneration

Panel and Podium Presentations at Ophthalmology Futures Forum, EURETINA Innovation Spotlight, and EURETINA Annual Congress

Aviceda Announces Podium Presentations on AVD-104, a Novel Glyco-Mimetic Nanoparticle for the Treatment of Geographic Atrophy from Macular Degeneration, at American Society of Retina Specialists (ASRS) and the OIS Retina Innovation Summit Meetings

Aviceda Therapeutics, a private late clinical-stage biotech company focused on developing next generation immuno-modulators by harnessing the power of glycobiology to alleviate chronic non-resolving inflammation, announces upcoming presentations about its lead ophthalmic clinical asset, AVD-104, a novel glycan-coated nanoparticle for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Aviceda Announces Dosing of First Patient With AVD-104, a Novel Glyco-Mimetic Nanoparticle for the Treatment of Geographic Atrophy from Macular Degeneration, in the Phase 2 SIGLEC Trial

Aviceda Therapeutics, a private clinical-stage biotech company focused on developing next generation immuno-modulators by harnessing the power of glycobiology to alleviate chronic, non-resolving inflammation, announced the dosing of its first patient with AVD-104 in its Phase 2 SIGLEC Trial today by Ashkan Abbey, MD of Texas Retina Associates in Dallas.

Aviceda Therapeutics Appoints Biopharma and Business Senior Executive Patrick Johnson, PhD, to its Board of Directors

Aviceda Therapeutics, a private clinical-stage biotech company focused on developing next-generation immunomodulators by harnessing the power of glycobiology to modulate the innate immune system and alleviate chronic, non-resolving inflammation with its lead ophthalmic asset, AVD-104, in late-stage clinical development for treatment of patients with geographic atrophy (GA), today announced the appointment of Patrick Johnson to its board of directors.

Aviceda Announces FDA Clearance of the Investigational New Drug (IND) Application for AVD-104, a Novel Glyco-Mimetic Nanoparticle, Enabling Initiation of Phase 2 Clinical Trials for the Treatment of Geographic Atrophy from Macular Degeneration

Aviceda Therapeutics, a private clinical-stage biotech company focused on developing next generation immuno-modulators by harnessing the power of glycobiology to modulate the innate immune system and alleviate chronic, non-resolving inflammation, today announced that the U.S. Food and Drug Administration (FDA) has cleared the IND for AVD-104.

Aviceda Therapeutics Announces Strategic Partnership with Queen’s University Belfast (QUB)

Aviceda is partnering with world-renowned scientist Professor Christopher Scott and his teams at the Patrick G. Johnson Centre for Cancer Research at Queen’s University Belfast to spearhead development of the next generation of glyco-immune therapeutics.

Aviceda Announces 3 Presentations about AVD-104, its Lead Glyco-mimetic Nanoparticle, As a Novel Treatment for Geographic Atrophy from Macular Degeneration, at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, April 2023

Aviceda Therapeutics, announced their upcoming oral and poster presentations at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual meeting in New Orleans.

Aviceda Announces Successful Submission of an Investigational New Drug (IND) and Fast Track Designation (FTD) Application for AVD-104 for the Treatment of Geographic Atrophy Associated with Age-Related Macular Degeneration (AMD)

Aviceda Therapeutics has completed a key regulatory milestone for its HALOS™ (High-Affinity Ligands of Sigelcs) technology platform and its lead ophthalmic drug candidate, AVD-104, a novel intravitreal glyco-conjugated nanoparticle.

Aviceda Announces Successful Completion of Key IND Toxicity Milestone with Favorable Safety Profile in Non-Human Primates

Aviceda Therapeutics has completed a key IND-enabling milestone for its HALOS™ (High-Affinity Ligands of Sigelcs) technology platform by demonstrating a very favorable safety profile at numerous tolerated doses of its lead ophthalmic drug candidate, AVD-104, in non-human primates and rabbits.

Aviceda Announces Additional World-Class Members to its Clinical Advisory Board to Support its Clinical Development Strategy in Ophthalmology

Aviceda Therapeutics, a clinical-stage biotech company focused on developing the next generation of immuno-modulators by harnessing the power of glycobiology to modulate the innate immune system and chronic, non-resolving inflammation, is announcing the addition of world-renowned top-tier ophthalmic key opinion leaders to its clinical advisory board.

Aviceda Therapeutics Announces Key Opinion Leader in Ophthalmology Drug Development Tarek S. Hassan, MD to Join Management Team as Chief Development Officer

Tarek Hassan, MD: Past President of American Society of Retina Specialists and Retina World Congress; Clinical researcher: global randomized clinical trials (>150), peer-reviewed (230); founder 6 medical device and/or medical education companies; holder of numerous issued patents and inventions

Aviceda Therapeutics Announces Strategic Alliance with University of Georgia

Aviceda is partnering with world-renowned glyco-chemist Prof. Geert-Jan Boons and analytical glyco-biologist Dr. Parastoo Azadi and their teams at Complex Carbohydrate Research Center (CCRC) to spearhead development of the next generation of glyco-immune therapeutics.

Aviceda Therapeutics Announces Additional World-Class Members to its Scientific Advisory Board

An internationally renowned group of scientists, researchers and clinicians will work with Aviceda’s in-house team to spearhead development of the next generation of glyco-immune therapeutics.

Aviceda Therapeutics Announces Formation of Executive Team

Aviceda has assembled a renowned team of scientific entrepreneurs and biopharma senior executives to spearhead ongoing development efforts of pipeline candidates and help the company continue to explore growth opportunities.

Aviceda Therapeutics Announces Formation of Scientific Advisory Board

An internationally renowned group of scientists, researchers and clinicians will work with Aviceda’s in-house team to spearhead development of the next generation of glyco-immune therapeutics.

Aviceda Therapeutics Appoints Biopharma and Business Veterans Chris Adams, PhD, MBA, and Nancy K. Thomason, MBA to its Board of Directors

“Chris and Nancy will add significant value to our world-class, cross-disciplinary team and scientific advisory board and will help continue the progress we..." said Mohamed A. Genead, MD, Chairman & CEO of Aviceda Therapeutics.