Altos Biologics, a subsidiary of Alteogen, is actively engaged in Eylea® Biosimilar (ALT-L9) clinical development and licensing-out discussions. Early 2024 projected for Phase 3 completion and product launch in Europe expected after obtaining approval in the first half of 2025.
DAEJEON, South Korea, Feb. 22, 2023 /PRNewswire/ — Alteogen Inc. (KOSDAQ:196170) (“Alteogen”), a leading biotechnology company based in South Korea, provided a patient enrollment update for the company’s ongoing Phase 3 study of ALT-L9 for the treatment of neovascular age-related macular degeneration (wet AMD).
ALT-L9 Phase 3 trial (EudraCT: 2021-004530-11) is a randomized, double-masked, parallel group, multicenter study to compare the efficacy and safety of ALT-L9 versus Eylea® in 431 patients with wet AMD. Full recruitment of study volunteers refers to the 431st patient identified as an eligible subject and subsequently enrolled in the trial. In line with schedule set forth in trial protocol, study volunteers go through the process of investigational product administration and observation by investigators.
“Patient recruitment process has been further expedited as Altos Biologics closely communicated with trial collaborators at the local level,” said an Alteogen official familiar with the study. “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. 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 study builds upon earlier Phase 1 study (NCT: 04058535), which successfully demonstrated similar safety and efficacy profiles to the originator product and evaluated pharmacokinetic characteristics. Additionally, filing and registration of formulation patents related to higher thermal stability and process patents, enabling efficient drug substance manufacturing, further bolster the product’s competitiveness from an intellectual property stance.
Eylea® is a leading treatment indicated for diabetic retinopathy and macular degeneration. In 2021 alone, the product clocked $5.8 billion in U.S. sales and worldwide, the revenue stood at $9.2 billion, making it one of the so-called blockbuster products. In an attempt to effectively capture Eylea® biosimilar market, Altos Biologics is pursuing licensing-out opportunities in each region.
About ALT-L9
ALT-L9 is an investigational compound intended to be a biosimilar formulation of aflibercept (product name Eylea®), an anti-vascular endothelial growth factor (VEGF). Alteogen intends to develop ALT-L9 for the same use as the reference product with respect to route of administration, posology, and therapeutic indications. One vial of ALT-L9 contains 11.12 mg of aflibercept (concentration of 40 mg/mL), and the layers of physicochemical and biological assays support the similarity of ALT-L9 to the reference product.
About Alteogen Inc.
Alteogen Inc. is a South Korea-based biotechnology company that focuses on the development and commercialization of biologics such as novel human hyaluronidase (ALT-B4), Antibody-Drug Conjugates (ADCs), biobetters and biosimilars. The company was founded in 2008 and listed in KOSDAQ (196170).
Contacts
US: Vivek Shenoy, Ph.D., MBA
Chief Business Officer of Alteogen
Phone: +18055708998
E-mail: [email protected]
ROW: In Young Han
General Manager, Business Development of Altos Biologics
Phone: +82 2 2039 9520 (ext. 235)
E-mail: [email protected]