TOKYO, Oct. 23, 2023 /PRNewswire/ — Longbio Pharma (Suzhou) Co., Ltd. (abbreviated as “Longbio Pharma”), a biotech company specializing in the development of treatments for allergy, asthma, nephrology, dermatology, ophthalmology and other autoimmune diseases, oral presented the phase I data of LP-003 (new generation of anti-IgE antibody) at the 72nd Annual Meeting of The Japanese Society of Allergology (JSA2023)
Title: Phase I study of LP-003, a novel high-affinity, long-acting anti-IgE antibody
Presentation number: EO3-6
Presentation Time: 21th October (Sat.) 9:00-10:00 (JST, GMT+9)
Results: LP-003 has high IgE binding affinity (>100-fold) without off-target binding, more potent FcεRI inhibition and higher FcεRII/CD23 inhibition compared to omalizumab.
In a randomized, double-blind, single-ascending-dose Phase I clinical study (CTR20221413), 32 healthy subjects were randomly divided into five groups to receive a single intravenous dose of 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg and 10 mg/kg respectively. Safety, pharmacokinetics, and pharmacodynamics (free IgE levels) profile was evaluated.
LP-003 exhibited a non-linear PK characteristic with T1/2 ranging from 46.3 days to 75.6 days, which is approximately 2～3 fold of Omalizumab. Moreover, the free-IgE was suppressed to below detection range for more than 70 days at 1 mg/kg group (except one with high baseline IgE level) to 10 mg/kg group.
LP-003 appears to show good safety profile. No Grade 3 and above TEAE was reported, establishing a solid foundation for further investigation and advancement.
“This presentation provides the opportunity to share our first-in-human data for LP-003 to the Japanese allergy community. And the Phase I data is truly exciting and represents a significant milestone,” exclaimed by Dr. Sun, Nai-chau, co-founder of Longbio Pharma, also the inventor of omalizumab and co-founder of Tanox Inc. “The positive results reinforce our belief in the best-in-class potential of LP-003 and its capacity to address the urgent needs of patients afflicted by allergic diseases, like allergic rhinitis. Japan is a country with a high incidence of allergic diseases and grapples with the burden of these conditions. LP-003 would be a novel treatment option to Japanese patients.”
Longbio Pharma has initiated Phase II clinical trials to build upon the promising results obtained in Phase I and to gather more comprehensive data. The company is actively seeking collaborations and partnerships within the industry to expedite the development and commercialization of LP-003, ultimately aiming to provide a revolutionary treatment option for patients in Japan and worldwide.
LP-003, a novel monoclonal anti-IgE antibody was generated, humanized, and engineered by Dr. Sun, Nai-chau, who is the inventor of Omalizumab, and co-founder of Tanox. Based on the 30+ years R&D experience on IgE target, Dr Sun developed a new generation of anti-IgE antibody (LP-003). Its extensive characterization including: affinity, bioactivity (FcεRI inhibition and higher FcεRII/CD23), off-target binding and animal study (Tox and efficacy) was conducted. The current data shows LP-003 is potentially to become a best-in-class treatment.
Two phase II study, with indication of allergic rhinitis or chronic spontaneous urticaria, are on-going. The company expects to have the topline result for LP-003 Phase II study by the end of 2023.
About Longbio Pharma
LongBio Pharma is a biotech company located in Shanghai/Changshu, China. The company, which was founded in 2020, focuses on autoimmune and complement diseases, serving patients and society.