Philadelphia,
US, March 1st, 2026 – Longbio Pharma (Suzhou)
Co., Ltd. (referred to as “Longbio”), a clinical-stage biotech company
focus on in-house discovery and development of biopharmaceuticals targeting on
allergic and autoimmune disease, proudly announced positive topline results
from Phase II clinical trial head-to-head comparing LP-003 to Xolair®(Omalizumab). The data was presented as late-breaking poster during the 2026AAAAI
Annual Meeting. The results demonstrated that
LP-003 achieved comprehensive clinical advantages over omalizumab, with
statistically superior outcomes in the key efficacy endpoints.
This
trial (NCT 06228560, CTR20233300) is a multicenter, randomized, double-blind,
placebo and active drug (omalizumab) controlled Phase II study, designed to evaluate
the efficacy and safety of LP-003 in patients with chronic spontaneous
urticaria (CSU) who remain symptomatic despite antihistamine (H1) treatment. A
total of 202 patients were enrolled and randomly assigned to one of three
LP-003 treatment groups (100 mg once every 4 weeks [Q4W], 200 mg Q4W, 200 mg
once every 8 weeks [Q8W]), the omalizumab group (300 mg Q4W), or the placebo
group, with a total treatment duration of 24 weeks.
In
this head-to-head trial against omalizumab, LP-003 exhibited comprehensive
superiority in efficacy, a faster onset of action, and a favorable safety
profile, further confirming its potential as a best-in-class anti-IgE therapy.
LP-003
Demonstrates Comprehensive Efficacy Superiority Over Omalizumab and Faster
Onset
For
the primary endpoint, at Week 12, the proportions of patients achieving UAS7=0
were 44.4%, 66.7%, 57.5%, 43.6% and 10.3% in the LP-003 100 mg Q8W, 200 mg Q8W,
200 mg Q4W, Omalizumab, and placebo groups, respectively (200 mg Q8W vs.
Omalizumab, p=0.0405).
For
the second key efficacy endpoint, 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, 200
mg Q8W, 200 mg Q4W, Omalizumab, and placebo groups, respectively (200 mg Q8W
vs. Omalizumab Δ-4.78, p=0.0137;
200 mg group [Q8W + Q4W] vs. Omalizumab Δ-3.82,p=0.0223).
By
Week 4, the complete remission rate across LP-003 groups reached 35%-35.9%. Compared
to Omalizumab, LP-003 showed faster onset efficacy.
LP-003
showed statistically significant and clinically meaningful superiority compared
to omalizumab in two key efficacy measures, in addition to a favorable
safety profile.
The
leading indication of LP-003 is seasonal allergic rhinitis (SAR), which is expected
to submitted Biologics License Application (BLA) to NMPA (China) in or before the
third quarter of 2026. Once approved, LP-003 will become the first and only
innovative anti-IgE drug to file for marketing globally in more than 20 years
since omalizumab was approved.
About
LongBio
LongBio
is a clinical-stage biopharmaceutical company. Established in 2020 and located
in Shanghai and Suzhou, China, LongBio primarily focus on in-house discovery
and development of biopharmaceuticals targeting on allergic and autoimmune
diseases.
LP-003
is an anti-IgE antibody developed by LongBio with novel sequencing targeted at
treating allergic diseases, including seasonal AR, CSU, allergic asthma, CRSwNP
and food allergy. LP-003 shows much higher bioactivity than omalizumab, with
860-fold greater IgE binding affinity and 30-fold higher blocking activity. In
addition to its potent biological activity, LP-003 has a longer half-life of 45
to 76 days.
The
Phase III clinical trial in China for seasonal AR indication has completed
patient enrollment with BLA submission to NMPA planned in or before Q3 2026.
Phase III trial for CSU in China is expected to start in H1 2026.
