Avirmax Biopharma Prepares for IND-Enabling Study of ABI-201

Avirmax Biopharma has announced the initiation of Investigational New Drug (IND)-enabling studies for ABI-201, a novel AAV vector-based gene therapy designed to combat retinal diseases. ABI-201 delivers three therapeutic genes to regulate complement activation, reduce inflammation, and protect retinal cells, potentially preventing vision loss.

Key Highlights

       • ABI-201 is an AAV vector therapy designed for sustained gene expression with a single intravitreal injection.

       • The therapy targets retinal pigment epithelial cells and photoreceptors, aiming to halt disease progression and preserve vision.

       • Preclinical studies in multiple animal models, including Cynomolgus monkeys, have demonstrated anticipated biological functions.

       • The vector utilizes Avirmax Biopharma’s proprietary engineered capsid, AAV.N54, for targeted macular gene expression.

       • ABI-110, another therapy using the same capsid, is currently in Phase 1/2a trials for wet AMD.

       • IND-enabling studies will evaluate safety, tolerability, biodistribution, transgene expression, and pharmacokinetics.

       • Avirmax Biopharma plans to submit an IND application for ABI-201 in Q4 2025.

Industry Impact

ABI-201 represents a significant step forward in gene therapy for ophthalmology. If successful, it could offer a long-lasting treatment option for dry AMD and other retinal disorders, reducing the need for frequent injections and improving patient quality of life.

Expert Insights

“We are excited to reach this critical milestone in ABI-201 development,” said Shengjiang Shawn Liu, Chief Executive Officer of Avirmax Biopharma. “ABI-201 has the potential to revolutionize the treatment for dry AMD and many other retinal disorders.”

Future Outlook

As Avirmax Biopharma progresses through IND-enabling studies, the company remains focused on achieving regulatory approval and advancing clinical trials. With a projected IND submission in late 2025, ABI-201 could pave the way for a new era in retinal disease treatment.

Conclusion

The development of ABI-201 underscores the potential of gene therapy in ophthalmology. With promising preclinical results and a well-defined path toward regulatory approval, this innovative treatment could reshape how retinal diseases are managed in the future.