Novel Anti-IgE Antibody LP-003 Shows Superior Efficacy Over Omalizumab in Chronic Spontaneous Urticaria Trial
核心洞察
Longbio (搜索)'s LP-003 demonstrated superior improvement in UAS7 scores compared to Omalizumab at weeks 4 and 12 in Phase II trial for Chronic Spontaneous Urticaria (搜索) treatment.
The novel long-acting anti-IgE (搜索) antibody showed rapid symptom relief with a favorable safety profile and extended dosing interval of up to 8 weeks, potentially offering better treatment convenience.
Results position LP-003 as a potential best-in-class therapy in the growing CSU market, with comparable efficacy to barzolvolimab and plans for expansion into food allergy and asthma indications.
Longbio (搜索) Pharma announced breakthrough interim results from its Phase II clinical trial of LP-003, a novel long-acting anti-IgE (搜索) antibody, for the treatment of Chronic Spontaneous Urticaria (搜索) (CSU) at the 2025 American Academy of Allergy, Asthma & Immunology annual meeting (AAAAI 2025) in San Diego.
Superior Efficacy and Extended Dosing Benefits
The multi-center, double-blind, placebo-controlled study evaluated multiple dosing regimens of LP-003 against Omalizumab and placebo, with 40 patients per group. LP-003 demonstrated superior improvement in mean change of UAS7 (urticaria activity score 7) from baseline at week 12, alongside higher percentages of patients achieving complete symptom resolution (UAS7=0) at both week 4 and week 12.
Patients received LP-003 at doses of 100mg or 200mg every 8 weeks (Q8W), or 200mg every 4 weeks (Q4W), compared to standard 300mg Omalizumab treatment. The drug showed dose-dependent rapid and sustained relief of CSU symptoms while maintaining a favorable safety profile comparable to placebo.
Market Positioning and Clinical Impact
CSU affects approximately 1-2% of the global population, with about 35% of patients showing inadequate response to first-line antihistamine treatments. The U.S. market for CSU treatments is projected to reach $2 billion by 2026, with an expected 8-10% CAGR over the following five years.
LP-003's efficacy results proved comparable to barzolvolimab, an anti-C-KIT (搜索) mAb developed by Celldex (搜索), without raising additional safety concerns. Market research from RAPT indicates that healthcare providers prefer less frequent dosing schedules, even with marginally lower efficacy, making LP-003's extended dosing interval particularly attractive.
Expanding Therapeutic Applications
Following its success in allergic rhinitis, Longbio (搜索) is advancing LP-003's development program across multiple allergic conditions. The company has initiated a Phase II trial in asthma, with China's NMPA approving a quarterly dosing schedule. Additionally, LP-003 received IND approval for food allergy studies, targeting a market estimated to exceed $10 billion USD.
Clinical Trial Details
The Phase II trial (NCT06228560) focuses on evaluating LP-003's efficacy and safety in CSU patients. Key endpoints include:
- Primary: Proportion of participants achieving complete symptom resolution (UAS7 = 0) at week 12
- Secondary: Mean UAS7 change from baseline at weeks 4 and 12
- Safety and additional efficacy measures
Dr. James Chen, Principal Investigator at the San Diego Research Center, noted, "The interim results suggest LP-003 could represent a significant advancement in CSU treatment, offering patients both improved efficacy and a more convenient dosing schedule."