ABI-201 / Avirmax Biopharma - LARVOL DELTA

Inhibition of Laser Induced Choroidal Neovascularization (LCNV) by Blocking Complement Activation Cascade Using AAV Vectors Carrying Complement Inhibition proteins (ASGCT 2025) - "The study also evaluated the localized therapeutic effects of these constructs compared to VEGF inhibition using Eylea as a control. Mice treated with the vehicle exhibited the largest lesion sizes and highest intensity of injury, confirming the model's sensitivity. Among the treatments, ABI-202 (sCD59+C3i fusion protein) demonstrated the greatest reduction in lesion size and leakage intensity, likely due to its dual mechanism of complement inhibition and the protective effects of the fusion protein. ABI-201 (sCD59+C3i fusion protein) was the next most effective, showing enhanced lesion healing through a combination of complement inhibition and protective properties of the fusion protein."

Age-related Macular Degeneration • Inflammation • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Protective Efficacy of ABI-201 in a Sodium Iodate-Induced Retinal Damage Model of Dry AMD in Non-Human Primates (ARVO 2025) - "Compared to an existing treatment, Syfovre®, ABI-201 performed better in maintaining vision-related functions.In lab tests, the protective component of ABI-201 also shielded human eye cells from damage caused by oxidative stress, a major factor in retinal diseases. Importantly, the treatment was safe, with no signs of inflammation or other side effects.These findings suggest ABI-201 has the potential to offer a new, highly effective way to protect vision in people at risk of losing sight due to conditions like dry AMD, providing hope for better outcomes and improved quality of life."

Clinical • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders • CD59

Avirmax Biopharma Initiates IND-enabling Studies of ABI-201; a Breakthrough Gene Therapy for Dry Age-related Macular Degeneration (PRNewswire) - "Avirmax Biopharma, Inc...today announced the commencement of Investigational New Drug (IND)-enabling studies of ABI-201, a potential first-in-class AAV vector that delivers three genes to correct the dysregulation of complement activation, anti-inflammation, to protect retinal pigment epithelia and photoreceptors as well as to block retinal neovascularization. ABI-201 is constructed to achieve durable expression of these transgenes in eye only after a single intravitreal injection, thereby preventing retinal pathogenesis and preserving vision. In vivo studies conducted across multiple animal species, including Cynomolgus monkeys, have demonstrated the anticipated biological functions of the therapeutic genes encoded by the ABI-201 vector....Avirmax Biopharma anticipates submitting an IND application for ABI-201 in the fourth quarter of 2025. Pending regulatory clearance, the company plans to initiate phase 1/2a trials in patients with dry AMD shortly thereafter."

IND • New P1/2 trial • Preclinical • Age-related Macular Degeneration • Dry Age-related Macular Degeneration