Breakthrough! Exciting interim Phase II Data of LP-003 in CSU released by Longbio at AAAAI 2025

SAN DIEGO, March 2, 2025 /PRNewswire/ -- Longbio Pharma (Suzhou) Co., Ltd. (referred to as "Longbio"), a leading biotech company dedicated to developing innovative biologic treatments for allergy, respiratory, dermatology, hematology, ophthalmology, and other autoimmune and rare diseases, proudly announced the release of interim analysis of CSU (Chronic Spontaneous Urticaria) Phase II data for LP-003, the novel long-acting anti-IgE antibody, at the 2025 American Academy of Allergy, Asthma & Immunology annual meeting (AAAAI 2025). LP-003 demonstrated superior improvement compared to Omalizumab in mean change of UAS7 (urticaria activity score 7) from baseline and percentage% of patients with UAS7=0 at week 4 and week 12.

The presentation of the poster titled "An interim analysis of Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for CSU" by LongBio marked a significant moment during the conference.

Title: An interim analysis of Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for CSU

ClinicalTrials.gov ID: NCT06228560

Date and Time: March 2nd, 2025, 9:45 am (UTC -5)

Location: Convention Center, Ground Level, Hall A.

Poster Number: 685

Methods: This is a multi-center, double-blind, placebo-controlled Phase II clinical study, randomized to receive 100 mg Q8W, 200 mg Q8W or 200 mg Q4W of LP-003 or 300mg Omalizumab or placebo (n=40/group). The primary endpoint is the proportion of participants achieving complete absence of wheals and itching (UAS7 = 0) at week 12. Secondary endpoints include mean change of UAS7 from baseline at week 4 and 12, and other efficacy and safety endpoints.

Comparing to the first-generation anti-IgE antibody, omalizumab, LP-003 shows:

• superior improvement in mean change of UAS7 from baseline at week 12 as well as the percentage% of patients with UAS7=0 at week 4 and week 12.
• rapid and sustained relief in CSU symptoms in a dose-dependent manner.
• favorable safety profile, no statistically significant difference in adverse events were found between LP-003 and placebo groups.

These results suggested that LP-003 might become a best-in-class anti-IgE therapy.

In addition, LP-003's efficacy result was also comparable to barzolvolimab without raising any new safety concerns. Barzolvolimab is an anti-C-KIT mAB developed by Celldex, and intended to explore its application in CSU field. Together with its long-acting profile, LP-003 stands as a strong challenger in CSU market, positioning it at the forefront of the CSU treatment.

CSU stands as a prevalent skin disorder affecting approximately 1–2% of the global population. Not only that, ~35% patients are not well controlled or refractory to the first-line treatment (anti-histamines). The US market size will reach $2 billion USD in 2026 and increase by 8-10% CAGR in next five years. According to the market research from RAPT, even with efficacy 20% below omalizumab, prescribers still prefer less frequent dosing. LP-003 not only with achieving the longer dosing interval than omalizumab, but also showed superior efficacy. It marks a major step forward, positioning the LP-003 at the forefront of the anti-IgE field.

This achievement also marks a significant milestone for LP-003 following its initial success in allergic rhinitis, and LongBio is planning to continue exploring its promising potential in food allergy and asthma. The Phase II trial of asthma has started and the agency (NMPA, China FDA) approved a dosing interval of every 3 months (Q12W). LP-003 also got the IND approval of food allergy last year and planning to initial the clinical trial in the near future.

Food allergy is huge market with great potential (>$10 billion USD) but less competitors. Based on the epidemiology research, there are more than 13.5 million adults and 3.5 million children are suffering food allergy in US and anti-IgE therapy is the only approved MOA by FDA.

With ongoing studies in allergic rhinitis, CSU, asthma and food allergy, Longbio's innovative approach to biologic therapies continues to show remarkable potential for addressing unmet medical needs across allergic diseases. LP-003 would stand poised to make a significant impact on the global allergy and immunology markets.

About LongBio

LongBio is a biotech company located in Shanghai/Changshu, China. The company, which was founded in 2018, focuses on autoimmune and rare diseases, serving patients and society.

LongBio aims to bring our drugs to both domestic and international markets with our partners, especially to bring patients with more affordable and high-quality bio-medicines. Our leading pipeline is a next generation of anti-IgE antibody (LP-003), which is already in Phase III stage, and prepare for pre-BLA in 2025H2. LP-003 has started clinical studies of several indications, like allergic rhinitis, CSU and asthma. Another pipeline is a bifunctional complement inhibitor, LP-005, with fully inhibition of all three pathways in complement system. The Phase II of PNH of LP-005 is on-going at present, intending to explore renal diseases and neuroinflammations in the near future.

For more information, please visit: www.longbio.com or please contact: [email protected].

SOURCE LongBio