AVD-104 / Aviceda - LARVOL DELTA

Aviceda Therapeutics Raises Upsized $207.5 Million in Series C Financing Round to Advance Lead Program AVD-104 for Geographic Atrophy into Pivotal Trials (Businesswire) - "Aviceda Therapeutics...announced the closing of a $207.5 million Series C financing. Proceeds will support the ongoing Phase 2b/3 and planned pivotal Phase 3 clinical trial for AVD-104 in geographic atrophy (GA), a vision-threatening condition secondary to advanced age-related macular degeneration, and the expansion into other ophthalmic indications....Aviceda’s ongoing Phase 2b/3 trial evaluating two doses of AVD-104 versus avacincaptad pegol (Izervay) in patients with GA is fully enrolled, with 12-month primary endpoint data anticipated in the second half of 2025."

Financing • P2/3 data • Age-related Macular Degeneration

SIGLEC: A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) (clinicaltrials.gov) - P2 | N=300 | Active, not recruiting | Sponsor: Aviceda Therapeutics, Inc. | Trial completion date: Jun 2026 ➔ Sep 2026 | Trial primary completion date: Jun 2025 ➔ Sep 2025

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

SIGLEC: A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) (clinicaltrials.gov) - P2 | N=300 | Active, not recruiting | Sponsor: Aviceda Therapeutics, Inc. | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

SIGLEC: A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) (clinicaltrials.gov) - P2 | N=300 | Enrolling by invitation | Sponsor: Aviceda Therapeutics, Inc. | Active, not recruiting ➔ Enrolling by invitation

Enrollment open • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

SIGLEC: A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) (clinicaltrials.gov) - P2 | N=300 | Active, not recruiting | Sponsor: Aviceda Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Results From Phase 2/3 SIGLEC Trial Assessing AVD-104 for Geographic Atrophy: Glyco-immunologic Modulation of Macrophage Activity (AAO 2024) - No abstract available

P2/3 data • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Ophthalmology

A Phase 2 Study of Intravitreal AVD-104 in Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=21 | Terminated | Sponsor: Aviceda Therapeutics, Inc. | Active, not recruiting ➔ Terminated; Lack of Efficacy

Trial termination • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

Novel sialic acid–coated nanoparticle AVD-104 modulates macrophages and complement dysfunction in nonexudative AMD in the SIGLEC phase 2/3 clinical trial part 1 (ARVO 2024) - "AVD-104, a novel sialic acid–coated nanoparticle, has shown excellent safety in part 1 of the SIGLEC phase 2/3 trial. Preliminary data demonstrate favorable changes in patient BCVA across all cohorts. The case study highlights the observed slowing in GA lesion progression and improvements in BCVA."

Clinical • P2/3 data • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Novel sialic acid coated Nanoparticle AVD-104 demonstrates pre-clinical ocular and systemic safety (ARVO 2024) - "The nonclinical safety assessment of AVD-104 for safety pharmacology, genotoxicity, and ocular toxicity studies suggested a well-tolerated, safe drug with no systemic or ocular toxicity. These preclinical studies highlight the safety of AVD104, supporting our ongoing clinical trials as a promising candidate with a great safety profile and efficacy"

Preclinical • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders

A Phase 2 Study of Intravitreal AVD-104 in Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=21 | Active, not recruiting | Sponsor: Aviceda Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | N=30 ➔ 21

Enrollment change • Enrollment closed • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

A Phase 2 Study of Intravitreal AVD-104 in Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Aviceda Therapeutics, Inc.

New P2 trial • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

SIGLEC: A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) (clinicaltrials.gov) - P2 | N=287 | Recruiting | Sponsor: Aviceda Therapeutics, Inc. | N=210 ➔ 287

Enrollment change • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

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 (Businesswire) - "Aviceda Therapeutics...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)....'I am excited to present the first-in-human safety data from the Phase 2/3 SIGLEC trial evaluating intravitreal AVD-104.'"

P2/3 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

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 (Businesswire) - "Aviceda Therapeutics...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. This lead intravitreal asset is a novel glycan-coated nanoparticle, supported by a uniquely strong pre-clinical in vivo efficacy and safety profile, used for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)."

Trial status • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology

SIGLEC: A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) (clinicaltrials.gov) - P2 | N=210 | Not yet recruiting | Sponsor: Aviceda Therapeutics, Inc.

New P2 trial • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

SIGLEC: A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) (clinicaltrials.gov) - P2 | N=210 | Recruiting | Sponsor: Aviceda Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Aviceda announces FDA approval of the Investigational New Drug (IND) application for AVD-104, a novel glyco-mimetic nanoparticle, allowing initiation of Phase 2 clinical trials for the treatment of atrophy… (Businesswire) - "Aviceda Therapeutics...today announced that the United States Food and Drug Administration The United States (FDA) has cleared the IND for AVD-104. This will allow the company to initiate Phase 2 clinical trials of its leading intravitreal ocular active for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)."

IND • Age-related Macular Degeneration

Modulation of Retinal Inflammatory Macrophages by Sialic-Acid Coated Nanoparticles as Novel mechanism for Nonexudative AMD Treatment (ARVO 2023) - "The purpose of this study is to assess the mechanism of action of a novel sialic-acid-coated nanoparticle (NP) construct in dampening the inflammatory response by macrophages by binding specifically to Sialic-acid-binding immunoglobulin-type lectins (Siglecs) on retina macrophages followed by the activation of inhibitory cellular domains and recruiting Src homology region 2 domain-containing Phosphatase-1(SHP1) Methods We performed cell-based assays using our proprietary asset in two cell types; THP-1 and PBMC-derived macrophages treated with our AVD-104 to characterize the biological activities...Our data supports the use of a novel engineered NPs as a new potential approach for treatment of non-exudative AMD patients by inhibiting the pro-inflammatory macrophages via binding to Siglecs and SHP-1 recruitment Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your..."

Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders • IL10 • IL1B • IL6 • TNFA

Modulation of Macrophages and Complement Dysfunction in Nonexudative Age- Related Macular Degeneration Utilizing a Sialic-acid Coated Nanoparticle (ARVO 2023) - "The therapeutic molecule AVD-104 (Aviceda Therapeutics, Cambridge, MA) is an engineered dual function glycan (sialic-acid) nanoparticle that directly modulates the self-pattern recognition receptors on immune cells called Siglecs (sialic-acid binding immunoglobulin-like lectins), thereby dampening the inflammatory activity of macrophages and microglia...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders • TNFA

Targeting Self-Recognition Pattern Receptors on Retina Immune Cells with an Engineered Glycan-coated Nanoparticle as a Novel Therapy for Nonexudative AMD (ARVO 2023) - "AVD-104, an optimized sialic-acid (glycan) coated nanoparticle (Aviceda Therapeutics, Cambridge, MA) was engineered to directly agonize the self-pattern recognition receptors on retina immune cells called Siglecs (sialic-acid binding immunoglobulin-like lectins)...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Immune cell • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders