HAYWARD, CA, USA I May 30, 2024 I Avirmax Biopharma, Inc., a leading innovator in genetic medicines, is pleased to announce that it has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase I/IIa clinical trial for its gene therapy treatment targeting wet Age-related Macular Degeneration (AMD) including Polypoidal Choroidal Vasculopathy (PCV).

This significant milestone enables Avirmax Biopharma to commence clinical trials aimed at evaluating the safety, tolerability, and preliminary efficacy of its engineered adeno-associated virus (AAV) vector-mediated gene therapy in patients suffering from these debilitating ocular conditions. Wet AMD and PCV are major causes of vision loss, particularly in older adults, and current treatment options are limited. PCV is a common eye disorder in Asia and Africa but it is underestimated in the USA.

Avirmax Biopharma Receives IND Approval to Initiate Phase I/IIa Trial for Wet AMD Including PCV

“We are thrilled to have received IND approval to advance our genetic medicine program into clinical trials,” said Dr. Shengjiang Shawn Liu, CEO of Avirmax Biopharma. “This approval represents a crucial step forward in our mission to develop innovative treatments for retinal diseases and improve the quality of life for patients affected by wet AMD including PCV.”

The Phase I/IIa trial will be conducted at multiple clinical sites across the United States and will enroll patients with a diagnosis of wet AMD including PCV. The trial’s primary objectives are to assess the safety and tolerability of the AAV vector-mediated gene therapy, while secondary objectives include evaluating its impact on visual acuity.

Avirmax Biopharma’s proprietary gene therapy utilizes an engineered capsid, AAV2.N54, to efficiently deliver therapeutic transgene to the macular retina via intravitreal (IVT)  administration. This approach aims to provide a long-lasting treatment effect, potentially reducing the need for frequent intravitreal injections that are the current standard of care.

About Avirmax Biopharma

Avirmax Biopharma, Inc., based in the San Francisco Bay Area, is a clinical stage biopharmaceutical company dedicated to the development of genetic medicines to treat ocular diseases. Utilizing proprietary AAV vector technologies, Avirmax Biopharma aims to deliver safe, effective, and accessible gene therapies to improve patient outcomes and preserve vision. For more information, please visit https://avirmax.com/biopharma/.

SOURCE: Avirmax