LONGBIO-B has announced that its clinical trial application for LP-003 targeting the peanut allergy indication has received approval from the U.S. Food and Drug Administration (FDA).
Food allergies, including peanut allergy, are conditions triggered by an abnormal immune response to dietary components, typically proteins. These reactions can be mediated by IgE, non-IgE mechanisms, or a combination, leading to diverse clinical manifestations affecting the skin, gastrointestinal tract, respiratory system, and cardiovascular system. Food allergies are a leading cause of anaphylactic shock.
The global population suffering from food allergies has grown significantly, increasing from 273 million in 2018 to 362 million in 2024, representing a compound annual growth rate of 4.8%. With the prevalence of food allergies continuing to rise, the number of affected individuals worldwide is projected to reach 456.7 million by 2030, with a CAGR of 4.0% from 2024 to 2030.
LP-003 is an anti-IgE antibody featuring a novel sequence design. It is targeted for the treatment of various allergic diseases, including seasonal allergic rhinitis, chronic spontaneous urticaria (CSU), allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and food allergies.
The primary mechanism of LP-003 is to block free IgE in the blood and tissues, thereby inhibiting the initiation of IgE-mediated allergic reactions. It achieves this by binding to free, excess IgE, preventing it from attaching to the high-affinity IgE receptor FcεRI.
IgE is the core mediator of Type I hypersensitivity reactions. These reactions, triggered by allergens in different organs, lead to conditions such as seasonal allergic rhinitis, allergic asthma, CSU, food allergies, and other allergic disorders.
Given their ability to block the allergic cascade, anti-IgE antibodies play a crucial role in treating various allergic conditions. Anti-IgE therapy has been incorporated into Chinese diagnostic and treatment guidelines for seasonal allergic rhinitis and CSU.
The company has already secured Investigational New Drug (IND) approvals in China for LP-003 targeting multiple indications and has initiated or is conducting related clinical trials. These indications include seasonal allergic rhinitis, CSU, allergic asthma, CRSwNP, and food allergies.
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