Aviceda Therapeutics, Inc.

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.

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 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 positive topline data of Part 1 of the Phase 2/3 SIGLEC trial for AVD-104 in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), showing positive safety and efficacy outcomes which were observed at 3 months after a single dose of AVD-104. “We are excited to see signs of significant visual & functional improvement and rapid reduction in the rate of GA lesion growth with a positive overall safety pro a single dose of AVD-104,” explained David Callanan, M.D., Aviceda’s Chief Medical Officer and Senior Vice President. “We look forward to initiating Part 2 of SIGLEC, in which we hope to demonstrate the capability of AVD-104 to provide a meaningful improvement over therapy that is only based in complement inhibition.” “As a company overseeing the development of a novel disease-approach to GA therapy, we are encouraged by the outcomes of Part 1 of SIGLEC, and believe that AVD-104’s dual mechanism of action, which resolves both macrophage/microglial- and complement-mediated inflammation, may lead to a paradigm shift for the treatment of GA,” Mohamed Genead, M.D., Co-founder and CEO said. “In particular, we feel that putting the brakes on both the cellular and humoral drivers of disease progression in the junctional zone, the leading edge of GA, is critical for an effective, disease-modifying treatment for GA, and the results of Part 1 of SIGLEC provide evidence that AVD-104 is effective in this regard.” SIGLEC is a two-part Phase 2/3 clinical trial based in the United States that is designed to evaluate the safety, pharmacokinetics, and efficacy of intravitreal AVD-104 in patients with GA secondary to AMD. Part 1 of the trial, 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, has now been completed. All patients in Part 1 of the trial tolerated a single dose of AVD-104 at month 3, and no drug-related ocular or systemic severe adverse reactions were observed. A greater reduction in GA lesion progression at 3 months was seen when compared to historical standard-of-care outcomes. Significant best corrected visual acuity (BCVA) gains were observed after a single AVD-104 injection and were sustained at 3 months. Junctional zone hyperautofluorescence, an imaging biomarker of rapid disease progression, was independently graded from fundus autofluorescence imaging, and was notably decreased in eyes receiving therapeutic doses of AVD-104 during the study period. Part 2 of the SIGLEC trial is a multi-center, double-masked, randomized, controlled trial that will evaluate the efficacy and safety of AVD-104 compared with an active comparator (avacincaptad pegol) for the treatment of GA secondary to AMD. It will enroll approximately 300 patients, who will be dosed for 12 months, with the opportunity to remain in the study for an additional 12 months. The primary endpoint will be the difference in growth rate of the GA area in treated patients versus 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. 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. 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. 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 US. Along with AVD-104, Aviceda has a broad pipeline of products in development in ophthalmology and multiple other therapeutic areas, including oncology, immunology, neurology, and fibrosis. Learn more about Aviceda Therapeutics.

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 that they have enrolled the first patient in the GLYCO Phase 2 U.S. clinical trial evaluating their lead ophthalmic candidate AVD-104 for the management of diabetic macular edema (DME). 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. Ashkan Abbey, M.D., of Texas Retina Associates said, “I am honored to dose AVD-104 in the first patient in the GLYCO trial to evaluate its potentially next-generation dual mechanism of action to reduce the chronic inflammation that drives many cases of DME.” Mohamed Genead, M.D., Aviceda’s Co-founder and CEO said, “We are excited to evaluate the ability of AVD-104’s unique mechanism of action to provide DME patients with a safe treatment that may improve outcomes in eyes with DME driven by inflammatory and VEGF-mediated mechanisms.” “AVD-104 down-regulates neutrophils and has been shown to reduce the release of inflammatory cytokines,” explained David Callanan, M.D. , Aviceda’s Chief Medical Officer and Senior Vice President. “There is still a need for improvement in the treatment of DME and we believe it may offer therapeutic advantages in the management of DME, and potentially in diabetic ischemia.” The GLYCO Phase 2 U.S. clinical trial will evaluate the safety and treatment effects of intravitreal AVD-104 in patients with DME. This multi-center, open-label safety and tolerability study will enroll 30 patients to evaluate a low and high dose of AVD-104 with 3-month follow-up. The primary endpoint will be the incidence and severity of ocular and systemic adverse events. Secondary endpoint analyses will include standard evaluations of treatment efficacy, including macular thickness and vision. Further exploratory variables will include the potential effect of AVD-104 on macular ischemia. Further information regarding the GLYCO trial can be found 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 a clinical stage ophthalmic candidate, AVD-104, for the treatment of geographic atrophy 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 the activity of damaging neutrophils and phagocytic macrophages and repolarization of activated macrophages to their resolution state and 2) inhibition of complement cascade amplification. AVD-104 has completed dosing in the single ascending dose Part I of the company’s Phase 2/3 SIGLEC trial, which is evaluating patients with geographic atrophy secondary to AMD. Topline three-month data from Part I is expected in early 2024 along with the initiation of Part II, which is a double-masked, randomized, active comparator trial. Part II of the Phase 2/3 trial will enroll 300 patients across U.S. clinical sites. Along with AVD-104, Aviceda has a broad pipeline of products in development in ophthalmology and multiple other therapeutic areas, including oncology, immunology, neurology, and fibrosis. Learn more about Aviceda Therapeutics .