Longbio Pharma (Suzhou) has reported positive topline results from a Phase I clinical trial of LP-003, a new long-acting anti-IgE antibody, for the treatment of allergic rhinitis.
The double-blind, randomised study has evaluated the pharmacokinetics, pharmacodynamics (free IgE levels) profile and safety of LP-003 in healthy subjects.
Subjects were randomised into five groups and administered intravenously with a single dose of 0. mg/kg, 1mg/kg, 3mg/kg, 6mg/kg and 10mg/kg, respectively.
A non-linear PK characteristic with T1/2 ranging from 46.3 days to 75.6 days was observed in patients, which is approximately 2～3 fold of omalizumab.
LP-003 also demonstrated high IgE binding affinity (>100 fold) without off-target binding and showed more potent FcεRI and FcεRII/CD23 inhibition in comparison with omalizumab.
Groups administered with 1 mg/Kg (except one with high baseline IgE level) to 10 mg/Kg showed suppression of free-IgE below the detection range for more than 70 days.
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LP-003 showed a good safety profile with no Grade 3 and above TEAE.
Longbio Pharma co-founder and inventor of omalizumab Dr Sun, Nai-chau said: “The positive results reinforce our belief in the best-in-class potential of LP-003 and its ability to address the urgent needs of patients suffering from allergic diseases, like allergic rhinitis.”
Based on the positive data from the Phase I study, the company has started Phase II clinical trials of LP-003.
Longbio is also planning to collaborate with industry stakeholders for developing and marketing LP-003 globally.
A Phase II study of LP-003 in chronic spontaneous urticaria is also ongoing.