South Korea's Alteogen Inc. announced that its subsidiary Altos Biologics has successfully completed patient enrollment in its global Phase III clinical trial of ALT-L9, a biosimilar version of Regeneron's blockbuster drug Eylea (aflibercept) for the treatment of neovascular age-related macular degeneration (wet AMD).
The Phase III trial (EudraCT: 2021-004530-11) is designed as a randomized, double-masked, parallel group, multicenter study comparing the efficacy and safety of ALT-L9 versus Eylea in 431 patients with wet AMD. This milestone achievement keeps the company on track with its development timeline for the potential biosimilar.
Trial Design and Development Progress
The current Phase III study builds upon a successful Phase I trial (NCT: 04058535) that demonstrated similar safety and efficacy profiles to the reference product while also evaluating pharmacokinetic characteristics. According to an Alteogen official, "Patient recruitment process has been further expedited as Altos Biologics closely communicated with trial collaborators at the local level."
ALT-L9 is formulated as a biosimilar version of aflibercept, an anti-vascular endothelial growth factor (VEGF) therapy. Each vial contains 11.12 mg of aflibercept at a concentration of 40 mg/mL. The company has conducted extensive physicochemical and biological assays to support the similarity of ALT-L9 to Regeneron's Eylea.
Alteogen has also strengthened the competitive position of ALT-L9 through intellectual property protection, filing and registering formulation patents related to higher thermal stability and process patents that enable efficient drug substance manufacturing.
Market Opportunity and Commercialization Plans
Eylea represents a significant market opportunity, having generated $5.8 billion in U.S. sales and $9.2 billion in worldwide revenue in 2021 alone. The drug is a leading treatment for diabetic retinopathy and macular degeneration, classified as a blockbuster product in the pharmaceutical industry.
"We plan to complete the product approval by the first half of 2025 as biologics license application (BLA) will be submitted to the relevant health authorities in early 2024," stated the Alteogen representative. "Altos Biologics is also making great strides in licensing-out efforts and companies possessing marketing capabilities and a proven track record would be prime candidates in forging partnerships."
The company is actively pursuing licensing-out opportunities in various regions to effectively capture market share in the Eylea biosimilar market once regulatory approvals are secured.
About Wet AMD
Wet age-related macular degeneration is a chronic eye disorder that causes blurred vision or a blind spot in visual field due to abnormal blood vessel growth beneath the macula, the part of the retina responsible for central vision. The condition can lead to rapid and severe vision loss if left untreated.
Anti-VEGF therapies like Eylea work by inhibiting vascular endothelial growth factor, which is responsible for the abnormal blood vessel formation in wet AMD. These treatments have revolutionized the management of the disease, significantly improving outcomes for patients.
About Alteogen
Founded in 2008 and listed on KOSDAQ (196170), Alteogen Inc. is a South Korea-based biotechnology company focused on developing and commercializing biologics including novel human hyaluronidase (ALT-B4), Antibody-Drug Conjugates (ADCs), biobetters, and biosimilars. Its subsidiary, Altos Biologics, is specifically focused on the development and commercialization of the Eylea biosimilar program.
