DAEJEON, South Korea--(BUSINESS WIRE)--Alteogen Inc. (KOSDAQ:196170) announced that it has completed Phase 1 clinical trial of Eylea® Biosimilar (ALT-L9). The clinical trial was conducted at 4 major hospitals in Korea: Asan Hospital, Seoul National University Bundang Hospital, Samsung Seoul Hospital, and Severance Hospital. Alteogen has strengthened competitiveness through formulation patent registered in US, EU and Japan and filing of a process patent for PCT application.
Eylea® original product and Alteogen's Eylea biosimilar (ALT-L9) were randomly assigned 1:1 to 28 patients with neovascular (wet) age-related macular degeneration; the study design was double blinded, active control, and parallel. No adverse drug-related reactions were observed in both groups and showed similar improvement effects in best corrected visual acuity (BCVA) and central subfield thickness (CST). In this phase 1 clinical trial, Alteogen confirmed the safety and efficacy of ALT-L9 were similar to that of Eylea®. Alteogen intends to prove the similarity of ALT-L9 with Eylea® through a registrational phase 3 clinical trial. The results from the phase 1 trial in Korea will support the design of the phase 3 trial and potentially provide a path to a shorter phase 3 trial.
Eylea® is a drug for the treatment of wet macular degeneration, one of the major senile blindness diseases, along with cataracts and glaucoma. Based on public reporting by Regeneron, the market size was about USD 4.947 Billion in 2020 in the United States alone, making this a blockbuster drug.
“Alteogen is uniquely positioned based on our patent position to launch a Eylea biosimilar upon substance patent expiration,” said Dr. Soon Jae Park, Chief Executive Officer of Alteogen. “Our patent position will give us potentially commercial first mover advantage.”
Altos Biologics Inc., a fully owned subsidiary of Alteogen will be responsible for all future clinical and commercial development.
About Alteogen Inc.
Alteogen Inc. is a South Korea-based biopharmaceutical company that focuses on the development and commercialization of novel biologics such as Antibody-Drug Conjugates (ADCs), biobetters, and biosimilars. Alteogen’s portfolio includes clinical-stage long-acting therapeutic proteins and next-generation ADCs, developed by its proprietary NexP™-fusion and NexMab™ platform technology, respectively. It also developed a proprietary recombinant human hyaluronidase enzyme utilizing Hybrozyme™ technology, which enables the large volume subcutaneous administration of drugs that are typically administered as an IV injection. The company was founded in 2008 and listed in KOSDAQ (196170.KQ).