Avirmax Biopharma Inc receives IND approval from FDA

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The IND approval will allow the company 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).

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Avirmax Biopharma announced it has received Investigational New Drug (IND) approval from the US 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).

The company announced the approval in a press release and gave details about the prospective Phase I/IIa clinical trial.¹ According to the company, the trial will be conducted at multiple sites across the US and plans to enroll patients with wet AMD including PCV. The primary objectives of the trial will be to assess the safety and tolerability of the adeno-associated virus (AAV) vector-mediated gene therapy. Seconday objectives include evaluating the impact the AAV vector-mediated gene therapy will have on visual acuity.¹

The gene therapy from Avrimax Biopharma utilizes “an engineered capsid, AAV2.N54, to efficiently deliver therapeutic transgene to the macular retina via intravitreal (IVT) administration,” with the goal of “reducing the need for frequent intravitreal injections that are the current standard of care” according to the company.¹

Shengjiang Shawn Liu, PhD, CEO of Avirmax Biopharma, commented on the significance of the IND approval in a press release from the company.

"We are thrilled to have received IND approval to advance our genetic medicine program into clinical trials," said Liu. "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."