Alteogen to launch global P1 trial of Eylea biosimilar in 2019

Marian Chu  Published 2018.05.15  11:26  Updated 2018.05.15 11:26


Alteogen has wrapped up the pre-clinical trial for ALT-L9 - an Eylea biosimilar – saying it got results showing the biosimilar therapy to have a superior toxicokinetic and safety profile compared to the original.

Eylea (aflibercept), developed by Regeneron, is a blockbuster product that recorded $8.26 billion in sales last year, according to Pharma Compass. Eylea is a vascular endothelial growth factor (VEGF) inhibitor used to treat wet, advanced age-related macular degeneration, among other conditions.

The biosimilar company said it worked with MPI Research, a U.S. preclinical and early clinical contract research organization, for the past eight months to complete toxicity testing of ALT-L9 on monkeys.

According to Alteogen, the biosimilar demonstrated equivalence while showing superior pharmacokinetic, pharmacodynamic, and toxicokinetic profile. The therapy also showed no significant adverse effects compared to the placebo.

Alteogen said it plans to complete gathering data for the Investigational New Drug (IND) program by the end of this year to launch a phase 1 trial next year.

“We will prepare for a global phase 1 or phase 3 trial having secured the equivalence and safety profiles in preclinical results,” said Chung Kyung-hoon, director of the research center at Alteogen. “We also expect the ongoing licensing-out negotiations with a global pharmaceutical company we are working with to be accelerated.”

Alteogen has been busy securing its rights to launch the drug globally. The company said it completed patent registrations in 12 countries, including the U.S., to begin to sell their drug five years faster than others.

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