LongBio has announced that the National Medical Products Administration (NMPA) in China has approved its Investigational New Drug (IND) application for LP-003, a next-generation anti-IgE antibody, for the treatment of food allergy. This approval allows LongBio to initiate clinical trials for LP-003 in this indication.
Food allergy is a growing global health concern, affecting an estimated 2-10% of the population, depending on age and region. Current treatment options are limited, emphasizing the urgent need for novel therapies that not only improve symptom control but also provide long-acting sustained relief. The FDA's recent approval of omalizumab for food allergy in February 2024 has reinforced the therapeutic potential of anti-IgE treatment as a reliable and promising solution.
LP-003: A Next-Generation Anti-IgE Antibody
LP-003 is designed to offer improvements over existing anti-IgE therapies. LongBio reports that LP-003 boasts superior efficacy, a longer dosing interval (2-3 months compared to the 2-4 weeks typical of current treatments), and a favorable safety profile compared to omalizumab. These potential advantages could provide patients with a more convenient and effective option for managing allergic diseases.
Clinical Development Program
The food allergy indication is the fourth for which LP-003 has received IND approval. The company is currently conducting a Phase III trial for allergic rhinitis, as well as Phase II trials for chronic spontaneous urticaria (CSU) and asthma. Topline results from the Phase II clinical trial for CSU, which features a head-to-head comparison with omalizumab, have been accepted as a late-breaking poster presentation at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in February 2025 in San Diego, USA.
