SOFIA, Bulgaria I June 20, 2023 I Longbio Pharma (Suzhou) Co., Ltd. (abbreviated as “Longbio Pharma”), a pharmaceutical company that develops medicines for the treatment of allergy, asthma, ophthalmology and other autoimmune diseases, announced the preliminary phase I data of LP-003 (new generation of anti-IgE antibody) at the 29th Congress of European Rhinologic Society (ERS2023)

The poster “A Phase 1 study in healthy subjects of LP-003, a novel long-acting anti-IgE antibody for allergic rhinitis” submitted by Longbio Pharma is awarded as the “best poster” by the committee of the conference.

Poster Title: A Phase 1 study in healthy subjects of LP-003, a novel long-acting anti-IgE antibody for allergic rhinitis

Abstract Submission ID: 1209

Presentation Time: June 19, 2023, at 3:00 pm (GMT+3)

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 23 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 poster presentation provides the opportunity to share our first-in-human data for LP-003 to the international 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 ability to address the urgent needs of patients suffering from allergic diseases, like allergic rhinitis.”

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 also actively seeking collaborations and partnerships with industry stakeholders to accelerate the development and commercialization of LP-003, ultimately aiming to provide a game-changing treatment option to patients worldwide.

About LP-003
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.

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SOURCE: Longbio Pharma