Leo Pharma, Oneness Biotech and Microbio Shanghai enter license agreement for FB825

Leo Pharma, Oneness Biotech and Microbio Shanghai have entered into a worldwide exclusive licensing agreement for FB825, a novel atopic dermatitis and allergic asthma drug candidate, according to a press release.

FB825 targets the CmX domain of the membrane-bound IgE (mIgE), causing a depletion of the mIgE positive B-cells with a unique mechanism of action.

“Having seen the first-in-human data of FB825 and the reduction in Eczema Area and Severity Index scores, we feel that we are welcoming a promising novel drug candidate into our development pipeline,” Kim Kjoeller, MD, executive vice president, global research and development, Leo Pharma, said in the release. “No two patients are alike, and as there is a high unmet need, we are committed to building a diverse pipeline that represents a broad range of molecules and mechanisms of action.”

Leo Pharma will make an upfront payment of $40 million and milestone payments up to $530 million under the terms of the agreement. Oneness will conduct a phase 2a study of FB825 for the treatment of atopic dermatitis in the United States, while Microbio Shanghai will complete a phase 2 a study for allergic asthma in China.

Leo Pharma will take over development duties after these studies are completed.