LONGBIO-B (HKEX: 01779) has announced that the Phase III clinical trial for LP-003, targeting seasonal allergic rhinitis (hay fever), has successfully achieved its pre-defined primary endpoint. The results are reported to be of high statistical and clinical significance.

Allergic rhinitis is a chronic, non-infectious inflammatory condition of the nasal mucosa, primarily mediated by IgE in atopic individuals after allergen exposure. It is characterized by nasal inflammation triggered by allergens such as pollen, dust mites, animal dander, and mold. This condition is frequently associated with other allergic disorders, including asthma and conjunctivitis. Primary symptoms encompass sneezing, runny nose, nasal congestion, and itching, which can be seasonal or perennial depending on the allergen. Affecting 10% to 20% of the global population, allergic rhinitis is a major chronic respiratory inflammatory disease that significantly impairs patients' quality of life and socioeconomic status.

The Phase III trial for LP-003 in seasonal allergic rhinitis was a multicenter, randomized, double-blind, placebo-controlled study conducted in China. It aimed to compare the efficacy of LP-003 versus a placebo in patients with moderate-to-severe seasonal allergic rhinitis who had an inadequate response to standard therapy.

A total of 546 patients were enrolled and randomly assigned to two groups. One group received a 100 mg injection of LP-003 every four weeks (Q4W), while the other received a placebo injection on the same Q4W schedule.

Key inclusion criteria required patients to meet the diagnostic standards outlined in the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, revised edition) and to have an unsatisfactory response to standard treatment for seasonal allergic rhinitis. Major exclusion criteria involved patients with comorbidities other than seasonal allergic rhinitis.

The study's primary endpoint was to evaluate the clinical efficacy of LP-003, measured by the Total Nasal Symptom Score (TNSS) during the pollen peak period (PPP), in treating moderate-to-severe seasonal allergic rhinitis inadequately controlled by standard therapy.

Secondary endpoints focused on assessing the safety and additional efficacy measures of LP-003 for seasonal allergic rhinitis. These included evaluations of nasal and ocular symptoms, along with scores for rescue medication use (DNSMS and DNOMS), as well as pharmacokinetics (PK) and pharmacodynamics (PD).