LongBio's LP-003 Demonstrates Superior Efficacy Over Xolair in Phase II Chronic Urticaria Trial
核心洞察
LongBio announced positive Phase II results showing LP-003, a next-generation anti-IgE (搜索) antibody, achieved statistically superior efficacy compared to Xolair (omalizumab) in treating chronic spontaneous urticaria (搜索).
The 202-patient trial demonstrated LP-003's 200 mg Q8W dose achieved 66.7% complete remission rate versus 43.6% for Xolair at Week 12, with statistical significance (p=0.0405).
LP-003 showed faster onset of action with 35%-35.9% complete remission rates by Week 4 across treatment groups and exhibited a favorable safety profile.
LongBio Pharma (搜索) announced positive topline results from a Phase II clinical trial demonstrating that its next-generation anti-IgE (搜索) antibody LP-003 achieved statistically superior efficacy compared to Xolair (omalizumab) in patients with chronic spontaneous urticaria (搜索) (CSU). The data, presented as a late-breaking poster at the 2026 AAAAI Annual Meeting, represents a significant advancement in allergic disease treatment.
Trial Design and Patient Population
The multicenter, randomized, double-blind, placebo and active-controlled Phase II study (NCT06228560, CTR20233300) enrolled 202 patients with chronic spontaneous urticaria (搜索) who remained symptomatic despite antihistamine treatment. Patients were randomly assigned to one of three LP-003 treatment groups (100 mg Q4W, 200 mg Q4W, 200 mg Q8W), an omalizumab group (300 mg Q4W), or placebo, with a total treatment duration of 24 weeks.
Primary Efficacy Results
For the primary endpoint measuring complete symptom control, LP-003 demonstrated comprehensive superiority over omalizumab. At Week 12, the proportions of patients achieving UAS7=0 (complete absence of urticaria symptoms) were 44.4%, 66.7%, 57.5%, 43.6% and 10.8% in the LP-003 100 mg Q8W, 200 mg Q8W, 200 mg Q4W, omalizumab, and placebo groups, respectively. The LP-003 200 mg Q8W dose achieved statistical significance compared to omalizumab (p=0.0405).
Secondary Efficacy Outcomes
The second key efficacy endpoint further confirmed LP-003's superior performance. LS mean changes from baseline in UAS7 at Week 12 were -23.15, -26.63, -24.74, -21.85 and -13.98 in the LP-003 100 mg Q8W, 200mg Q8W, 200 mg Q4W, omalizumab, and placebo groups, respectively. The LP-003 200 mg Q8W group demonstrated statistical significance versus omalizumab (p=0.0137).
Rapid Onset of Action
LP-003 exhibited notably faster onset of efficacy compared to omalizumab. By Week 4, the complete remission rate across LP-003 groups reached 35%-35.9%, demonstrating the therapy's ability to provide rapid symptom relief for patients with chronic spontaneous urticaria (搜索).
Safety Profile and Molecular Advantages
The trial results showed LP-003 maintained a favorable safety profile alongside its superior efficacy. According to LongBio, LP-003 possesses significant molecular advantages over omalizumab, including 860-fold greater IgE (搜索) binding affinity and 30-fold higher blocking activity. Additionally, LP-003 demonstrates a much longer half-life compared to omalizumab, potentially enabling less frequent dosing.
Regulatory Timeline and Market Impact
LongBio's primary indication for LP-003 is seasonal allergic rhinitis (搜索), with the company planning to submit a Biologics License Application to China's NMPA by the third quarter of 2026. The Phase III clinical trial in China for seasonal allergic rhinitis has completed patient enrollment. A Phase III trial for chronic spontaneous urticaria (搜索) in China is expected to begin in the first half of 2026.
If approved, LP-003 would become the first innovative anti-IgE (搜索) drug launched globally in over 20 years since omalizumab's approval, representing a significant milestone in allergic disease treatment. The company, established in 2020 and located in Shanghai and Suzhou, China, focuses on in-house discovery and development of biologics targeting allergic and autoimmune diseases, with LP-003 being developed for multiple allergic conditions including seasonal allergic rhinitis (搜索), chronic spontaneous urticaria (搜索), allergic asthma (搜索), chronic rhinosinusitis with nasal polyps, and food allergy (搜索).