Longbio Pharma Presented Positive Topline Phase 1 Results for LP-003 at JSA2023

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 T_1/2 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.

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.

For more information, please visit: www.longbio.com or please contact: [email protected]. 

Source : Longbio Pharma Presented Positive Topline Phase 1 Results for LP-003 at JSA2023

The information provided in this article was created by Cision PR Newswire, our news partner. The author's opinions and the content shared on this page are their own and may not necessarily represent the perspectives of Thailand Business News.