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LEO Pharma enters agreement to develop novel drug for atopic dermatitis, asthma


LEO Pharma has entered into a license agreement with Oneness Biotech and Microbio Shanghai for the development and commercialization of the investigational drug FB825 for the treatment of atopic dermatitis and asthma.

LEO Pharma announces they have entered into a license agreement with Oneness Biotech and Microbio Shanghai for the novel atopic dermatitis (AD) and asthma drug FB825, which covers commercialization and development of the drug.

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FB825 is a humanized monoclonal antibody equipped with a mechanism of action (MoA) that binds to the the CεmX domain of the membrane form IgE (mIgE), which triggers depletion of mIgE +B lymphocytes by stimulating apoptosis and antibody-dependent cellular cytotoxicity (ADCC).

This MoA has potential to treat AD by decreasing disease burden through reducing inflammatory mediators and IgE levels, according to a press release.1

“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 Kim Kjoeller, M.D., executive vice president of global research & development at LEO Pharma.

Currently, FB825 is slated for phase 2 trials for atopic dermatitis in the U.S. and asthma in China, with LEO taking charge of all future development following the conclusion of the phase 2a studies. Additionally, the drug was granted an orphan drug designation by the U.S. Food and Drug Administration for Hyper IgE Syndrome (HIES).

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“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,” says Dr. Kjoeller.


LEO Pharma Enters License Agreement with Oneness Biotech and Microbio Shanghai for FB825 a Novel Atopic Dermatitis and Asthma Drug Candidate. Business Wire. https://www.businesswire.com/news/home/20200415005265/en/LEO-Pharma-Enters-License-Agreement-Oneness-Biotech. Published April 15, 2020. Accessed April 15, 2020.

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