Avirmax Biopharma, Inc., a leader in genetic medicine innovation, is pleased to announce that it has obtained Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for the initiation of a Phase I/IIa clinical trial for its gene therapy treatment targeting wet Age-related Macular Degeneration (AMD) including Polypoidal Choroidal Vasculopathy (PCV).

This approval enables Avirmax Biopharma to begin clinical trials aimed at assessing the safety, tolerability, and preliminary efficacy of its engineered adeno-associated virus (AAV) vector-mediated gene therapy in patients suffering from these ocular conditions. Wet AMD and PCV are significant causes of vision loss, especially in older adults, and current treatment options are limited. PCV is particularly prevalent in Asia and Africa but is underrecognized in the USA.

"We are excited to have received IND approval to progress our genetic medicine program into clinical trials," said Dr. Shengjiang Shawn Liu, CEO of Avirmax Biopharma. "This approval represents a crucial step in our mission to develop innovative treatments for retinal diseases and enhance 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 diagnosed with wet AMD including PCV. The primary objectives of the trial are to assess the safety and tolerability of the AAV vector-mediated gene therapy, with secondary objectives including evaluating its impact on visual acuity.

Avirmax Biopharma's proprietary gene therapy utilizes an engineered capsid, AAV2.N54, to efficiently deliver therapeutic transgenes 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, which are currently the standard of care.

 

Source: prnewswire.com

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