FB825
INDICATION
Atopic Dermatitis, Allergic Asthma, HIES* (Hyper IgE Syndrome)
MECHANISM OF ACTION
FB825, a new generation of the therapeutic monoclonal antibody (humanized; IgG1) for allergic disease, specifically binds to the CεmX membrane-bound IgE B cells and induces targeted cells undergoing apoptosis and ADCC. It kills the IgE+ lymphocytes directly to prevent IgE-plasma cell differentiation and reduce IgE production. FB825 has both therapeutic and preventive effects in allergic diseases.
CURRENT STATUS
1.Worldwide license agreement with LEO Pharma A/S
2. Phase 2a trial in AD initiated in the US
3. Phase 2a trial in allergic asthma initiated in Taiwan
EFFICACY
FB825 completed the phase I clinical study in the US with confirmed safety results in healthy subjects. FB825’s first-in-patient exploratory study in Atopic Dermatitis has shown very promising data by achieving 67% in EASI-75 in 16 weeks, comparable to the only available biologic for AD.
MARKET POTENTIAL
Atopic dermatitis (AD) – also known as ‘atopic eczema’ – is a chronic, inflammatory, heterogeneous skin disease characterized by intense itch and eczematous lesions. AD is the most common inflammatory skin disease in the developed world, affecting up to 5% of adults across the US, Canada, Europe and Japan. According market analysis reports (Allied Market Research & Coherent Market Insights), the market size of atopic dermatitis and allergic asthma will reach 38 billion USD globally.
Note: FB825 was granted orphan drug designation by the US FDA for treatment of Hyper IgE Syndrome (HIES).