Longbio Pharma Presents LP-003 Phase II Results at AAAAI2024

Longbio Pharma, a prominent biotechnology firm specializing in the creation of innovative protein-based therapies for a range of conditions including allergies, respiratory issues, dermatological disorders, blood-related diseases, and ophthalmic conditions, has recently unveiled the initial findings from Phase II trials of a groundbreaking new medication, LP-003, at the esteemed American Academy of Allergy, Asthma & Immunology's annual gathering in 2024.

At the conference, a poster presentation was given detailing the Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody developed for the treatment of allergic rhinitis. The study, registered with ClinicalTrials.gov under the identifier NCT06046391, was a randomized, double-blind, and placebo-controlled trial. It involved 180 adults suffering from moderate to severe seasonal allergic rhinitis, who were divided into groups to receive either LP-003 at doses of 100mg or 200mg, or a placebo. All participants were also given standard-of-care treatment with nasal corticosteroids, with or without antihistamines. The main focus of the study was to measure the average nasal symptom score during the peak pollen period, with secondary endpoints assessing ocular symptom scores, immunogenicity, and the safety profile of the drug.

The results were promising, showing a significant reduction in the mean nasal symptom score for those in the LP-003 groups compared to the placebo group, with both p-values indicating statistical significance at less than 0.05. Furthermore, LP-003 demonstrated a favorable safety profile, with the incidence of adverse events being comparable between the treatment and placebo groups. The most commonly reported adverse events were hyperuricemia, upper respiratory tract infection, and nasopharyngitis.

In a comparison with the first-generation anti-IgE antibody, omalizumab, the study found that 100mg of LP-003 had efficacy comparable to 300mg of omalizumab. Additionally, subgroup analysis suggested that LP-003 might have superior bioactivity under similar pollen density conditions.

Dr. Sun Nai-chau, co-founder of Longbio Pharma and the inventor of omalizumab, expressed enthusiasm for the study's findings, highlighting the potential of LP-003 to significantly improve nasal symptoms in patients with uncontrolled seasonal allergic rhinitis, even when they are already receiving standard treatment. The reduced and fixed dosage of LP-003 is also expected to reduce the financial burden on both insurance companies and patients, making the drug more accessible and offering greater value in terms of pharmacoeconomics.

The successful Phase II study of LP-003 is a significant step forward in the treatment of allergic diseases. With Phase III trials scheduled to begin in March 2024, Longbio Pharma is set to continue its pursuit of excellence, establish international partnerships, and contribute to the advancement of allergy treatments worldwide.

LP-003, developed by Dr. Sun Nai-chau, is a new generation monoclonal anti-IgE antibody. With over 30 years of research and development experience on the IgE target, Dr. Sun has created LP-003, which has undergone extensive characterization in terms of affinity, bioactivity, off-target binding, and animal studies. The data from Phase I and II trials indicate that LP-003 has the potential to become a leading treatment option.

In addition to the study on allergic rhinitis, Longbio Pharma is also conducting a Phase II study on chronic spontaneous urticaria, further demonstrating the company's dedication to exploring a variety of therapeutic approaches. The company anticipates starting the Phase III study for allergic rhinitis in the first half of 2024 and expects to have the topline results for the LP-003 Phase III study by the end of the year.

Longbio Pharma, established in 2018 and headquartered in Shanghai/Changshu, China, is focused on developing treatments for autoimmune and rare diseases to benefit patients and society. The company's mission is to make high-quality bio-medicines more affordable and accessible to patients around the world. Its leading product in development is the next-generation anti-IgE antibody, LP-003, which is preparing to enter Phase III trials and aims to submit a Biologics License Application in the first half of 2025. Another key product in the pipeline is a bifunctional complement inhibitor, currently in Phase I, with plans to advance to Phase II/III trials in the second quarter of 2024.