Alteogen 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.
“Alteogen is uniquely positioned based on our patent position to launch a Eylea biosimilar upon substance patent expiration,” Dr. Soon Jae Park, Chief Executive Officer of Alteogen, said in a company news release. “Our patent position will give us potentially commercial first mover advantage.”
Altos Biologics, a fully owned subsidiary of Alteogen, will be responsible for all future clinical and commercial development.