LEO Pharma mounts another challenge to the eczema giants, betting $40M cash on a drug from China
LEO Pharma knows it’s in for a brawl with powerful players in atopic dermatitis. With some positive Phase III data in and regulatory filings on the way, the Danish drugmaker is shelling out $40 million upfront on a new drug candidate that goes at both eczema and asthma from a different angle.
The asset, FB825, comes out of a collaboration between Oneness Biotech in Taiwan and Microbio Shanghai in China. It hits the CεmX domain of the membrane bound IgE (mIgE), causing a depletion of mIgE positive B-cells and thereby lowering inflammation.
“Having seen the first-in-human data of FB825 and the reduction in Eczema Area and Severity Index scores (an indicator of AD severity), we feel that we are welcoming a promising novel drug candidate into our development pipeline,” said Kim Kjoeller, LEO Pharma’s EVP of global R&D, in a statement.
By targeting IgE, LEO is going down a similar path as Roche and Novartis’ Xolair, which is approved for asthma but also being studied for atopic dermatitis. But Xolair works on surface bound IgE.
In contrast, tralokinumab inhibits IL-13, a cytokine that leads to IgE production. Eli Lilly now has the other late-stage IL-13 in the eczema mix — lebrikizumab — after swallowing Dermira for $1.1 billion; Dupixent, the giant in the field developed by Sanofi and Regeneron, blocks both IL-13 and IL-4.
Oneness will complete a Phase IIa for atopic dermatitis in the US while Microbio Shanghai will finish a Phase IIa for allergic asthma in China, before handing over development to LEO Pharma. If it all goes smoothly, they are entitled to milestone payments up to $530 million plus tiered royalties.