LEO Pharma A/S has signed a worldwide exclusive licensing agreement with Oneness Biotech of Taiwan and Microbio Shanghai of China, covering the development and commercialization of the novel Atopic Dermatitis (AD) and Allergic Asthma drug candidate, FB825.

FB825 is a first-in-class drug candidate with a unique mechanism of action targeting the CεmX domain of the membrane bound IgE (mIgE), causing a depletion of mIgE positive B-cells. This new MoA holds promise as a treatment for atopic dermatitis and is expected to reduce the disease burden by lowering relevant inflammatory mediators as well as IgE levels.

Under terms of the agreement, LEO Pharma will make an upfront payment of USD 40 million and offer milestone payments up to USD 530 million, followed by a tiered high single-digit to double-digit royalties. Under the agreement, Oneness will be responsible for executing the Phase 2a study for Atopic Dermatitis in the United States and Microbio Shanghai will execute the Phase 2a study for allergic asthma in China. LEO Pharma will assume all the development responsibilities after the Phase 2a studies.

“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,” says Dr. Kim Kjoeller, Executive Vice President, Global Research & Development, LEO Pharma. “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 and both Oneness Biotech and Microbio Shanghai see great potential in FB825. If the anticipated treatment profile can be confirmed in the upcoming trials, the product can be expected to help a significant number of patients suffering from atopic diseases.