First Patient Enrolled in Aviceda's Phase 2 Trial for AVD-104 to Treat Diabetic Macular Edema

Aviceda Therapeutics, a clinical-stage biotech firm, is progressing with the development of a novel glycan nanoparticle, AVD-104, designed to mitigate inflammation by engaging with self-pattern recognition receptors on retinal immune cells. This engineered sialic acid nanoparticle is being studied for its potential to treat Diabetic Macular Edema (DME), alongside its primary focus on Geographic Atrophy (GA). The company has initiated a Phase 2/3 trial for GA patients, with the first patient enrolled.

Dr. Ashkan Abbey from Texas Retina Associates has expressed his honor in administering AVD-104 to the first participant in the GLYCO trial, highlighting its innovative dual-action mechanism to address the persistent inflammation associated with DME. Aviceda’s CEO, Dr. Mohamed Genead, underscores the company's enthusiasm to assess the nanoparticle's unique mechanism, which could provide a safe and effective treatment for DME patients.

The GLYCO Phase 2 U.S. clinical trial will assess the safety and efficacy of intravitreal AVD-104 in managing DME. This trial, which is open-label and multi-center, will involve 30 patients receiving varying doses of the nanoparticle and will conclude with a 3-month follow-up. The primary focus will be on the incidence and severity of ocular and systemic adverse events. Secondary endpoints will evaluate treatment efficacy through standard measures such as macular thickness and vision, with additional exploration into the nanoparticle's potential impact on macular ischemia.

Aviceda Therapeutics, based in Cambridge, MA, is utilizing its proprietary HALOS™ nanotechnology platform to advance AVD-104, which has a dual mechanism of action that modulates inflammatory pathways by inhibiting damaging neutrophils and macrophages and by preventing the amplification of the complement cascade. The company has completed dosing in the single ascending dose phase of its SIGLEC trial for GA patients and anticipates releasing topline data in early 2024.

Aviceda has a diverse pipeline of products under development, targeting areas such as ophthalmology, oncology, immunology, neurology, and fibrosis, with AVD-104 being a key candidate in its ophthalmic portfolio.