Abstract Submission ID: 1209
Results: LP-003 has high IgE binding affinity (>100 fold) without off-target binding, more potent FcεRI and FcεRII/CD23 inhibition compared to omalizumab. In a randomized, double-blind, 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 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. LP-003, a novel 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 of experience on IgE target, Dr Sun developed a new generation of anti-IgE antibody (LP-003). The current data shows LP-003 is potentially to become a best-in-class treatment. For more information, please visit: www.longbio.com or please contact: [email protected].