LONGBIO-B(01779): The phase III clinical trial of LP-003 for the treatment of seasonal allergic rhinitis has reached its primary endpoint.

LONGBIO-B (01779) issued an announcement that the Phase III clinical trial of LP-003 for seasonal allergic rhinitis (allergic rhinitis) has reached the pre-defined primary endpoint, and the results are of high statistical and clinical significance. Allergic rhinitis is a non-infectious chronic inflammatory disease of the nasal mucosa, mainly mediated by IgE in atopic individuals after exposure to allergens. It is characterized by nasal inflammation caused by allergens such as pollen, dust mites, animal dander, and mold. Allergic rhinitis is often associated with other allergic diseases (such as asthma and conjunctivitis). The main symptoms of allergic rhinitis include sneezing, runny nose, nasal congestion, and itching, which may be seasonal or persistent depending on the allergen. Globally, 10% to 20% of the population suffers from allergic rhinitis, making it a major chronic respiratory inflammatory disease that significantly affects patients' quality of life and socio-economic status. The Phase III clinical trial of LP-003 for seasonal allergic rhinitis indication is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study conducted in China, aiming to compare the efficacy of LP-003 with placebo in treating moderate to severe seasonal allergic rhinitis that is poorly controlled with standard treatment. A total of 546 patients have been enrolled in the study and randomized into two groups to receive either 100 mg of LP-003 injection every four weeks (Q4W) or placebo injection every four weeks (Q4W). The primary inclusion criteria for the trial were patients with seasonal allergic rhinitis who met the diagnostic criteria of the "Chinese Guidelines for Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition)" and did not respond satisfactorily to standard treatment. The main exclusion criteria were patients with complications other than seasonal allergic rhinitis. The primary endpoint of the study was to evaluate the clinical effectiveness of LP-003 in treating moderate to severe seasonal allergic rhinitis that is poorly controlled with standard treatment (total nasal symptom score (TNSS) during pollen peak period (PPP)). Secondary endpoints included evaluating the safety and efficacy of LP-003 in treating seasonal allergic rhinitis (daily nasal symptom and rescue medication score (DNSMS), daily ocular symptom and rescue medication score (DNOMS)), PK and PD.