SHANGHAI, Nov. 25, 2024 /PRNewswire/ — LongBio is proud to announce that the National Medical Products Administration (NMPA, China) has approved the Investigational New Drug (IND) application for LP-003, the company’s next-generation anti-IgE antibody, to begin a clinical trial for the treatment of food allergy.
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 a 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 boasts a significant advancement in anti-IgE therapies: superior efficacy, long-acting profile that has extended the dosing interval from 2-4 weeks to 2-3 months and favorable safety profile compared to Omalizumab. These advantages may provide patients with a more convenient and effective option for managing allergic diseases such as chronic spontaneous urticaria (CSU), food allergy, allergic rhinitis and asthma, which continues to significant impact public health and quality of life.
The food allergy is the fourth indication of LP-003 that approved by agency. The Phase III of allergic rhinitis, the phase II of CSU and asthma also on-going. Notably, the topline result of Phase II clinical trial for CSU—featuring a head-to-head comparison with omalizumab—has been accepted as a late-breaking poster by the American Academy of Allergy, Asthma & Immunology (AAAAI). The results will be presented at the AAAAI Annual Meeting in February 2025 in San Diego, USA.
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