#United States #Avirmax Biopharma #gene therapy #Hayward, California #ABI-201

Avirmax Biopharma's Innovative Approach to Dry AMD

Avirmax Biopharma, Inc., a prominent name in the field of gene therapy development, has officially launched its Investigational New Drug (IND) enabling studies for ABI-201. This novel therapy targets dry age-related macular degeneration (AMD), a condition that poses a significant risk of irreversible vision loss in older adults. With over 200 million individuals affected globally, addressing this medical challenge is critical.

Overview of ABI-201

ABI-201 is a cutting-edge AAV vector designed to deliver three therapeutic genes aimed at correcting the imbalance of complement activation, reducing inflammation, and protecting the retinal cells critical for vision, such as retinal pigment epithelia and photoreceptors. The therapy promises a pioneering single intravitreal injection that could result in sustained gene expression within the eye, potentially halting retinal disease progression and preserving eyesight for patients.

In preliminary in vivo studies involving various animal models, including Cynomolgus monkeys, ABI-201 has exhibited its expected biological benefits, reinforcing the hope that this innovative treatment can transform care for those suffering from dry AMD.

Significance of the Research

Shengjiang Shawn Liu, the CEO of Avirmax Biopharma, expressed enthusiasm regarding this milestone in ABI-201's development. "This advancement has the potential to revolutionize the treatment landscape for dry AMD and numerous associated retinal disorders," Liu stated.

The urgent need for effective interventions in dry AMD is underscored by the alarming fact that it accounts for 90% of all AMD cases, yet effective long-term therapies have been elusive. ABI-201 seeks to fill this gap, offering a promising solution aimed at inhibiting the progress of geographic atrophy (GA) and delaying the transition from dry to wet AMD, a more severe form of the condition that can lead to significant blindness.

The Technology Behind ABI-201

At the heart of ABI-201’s development lies Avirmax Biopharma's proprietary AAV.N54 capsid, which enhances the capacity to deliver genes specifically to the macula during intravitreal injection, a method that allows direct access to the eye's interior. Additionally, AAV.N54 is already being utilized in another project, ABI-110, which is currently undergoing Phase 1/2a clinical trials for wet AMD, indicating Avirmax's commitment to advancing eye health through innovative gene therapy.

Future Directions

The ongoing IND-enabling studies are focused on assessing ABI-201’s safety, tolerability, vector biodistribution, transgene expression, and pharmacokinetics in monkey models. Avirmax Biopharma aims to submit its IND application in the fourth quarter of 2025, which would pave the way for starting human trials shortly thereafter.

In a world where dry AMD affects millions, ABI-201 represents a potential paradigm shift in how this debilitating condition can be treated, signifying a beacon of hope for patients seeking viable therapeutic options.

About Avirmax Biopharma

Based in the San Francisco Bay Area, Avirmax Biopharma Inc. specializes in developing next-generation gene therapies specifically targeted at retinal diseases. Through its innovative AAV vector technology, the organization endeavors to deliver safe and effective therapies that enhance patient outcomes and protect vision. For more information, visit Avirmax Biopharma.