SAN DIEGO, March 12, 2024 /PRNewswire/ -- Longbio Pharma (Suzhou) Co., Ltd. (referred to as 'Longbio Pharma'), a leading biotech company dedicated to developing innovative protein treatments for allergy, respiratory, dermatology, hematology, ophthalmology, and other autoimmune and rare diseases, proudly announced the Phase I data of LP-003 (new generation of anti-IgE antibody) at the 2024 American Academy of Dermatology Association annual meeting (2024AAD)..

圣地亚哥，2024年3月12日/PRNewswire/--Longbio Pharma（苏州）有限公司（简称“Longbio Pharma”），一家领先的生物技术公司，致力于开发针对过敏、呼吸、皮肤病、血液病、眼科和其他自身免疫性和罕见疾病的创新蛋白质治疗方法，骄傲地宣布了LP-003（新一代抗IgE抗体）的I期数据在2024年美国皮肤病学会年会（2024AAD）上。。

The presentation of the poster titled 'A Phase 1 study in healthy subjects of LP-003, a novel long-acting, high affinity anti-IgE antibody' by Longbio Pharma marked a significant moment during the conference.

Longbio Pharma发布的题为“LP-003健康受试者的第一阶段研究（一种新型长效，高亲和力的抗IgE抗体）”的海报标志着会议期间的一个重要时刻。

Title: A Phase 1 study in healthy subjects of LP-003, a novel long-acting, high affinity anti-IgE antibodyAbstract Submission ID: 50484Presentation Time: Mar 8-12, 2024Location: Poster Exhibits CenterResults:In a randomized, double-blind, single-ascending-dose Phase I clinical study (CTR20221413), 32 healthy subjects were randomly divided into 5 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.

标题：LP-003健康受试者的第一阶段研究，一种新型长效，高亲和力的抗IgE抗体摘要提交ID:50484提交时间：2024年3月8日至12日地点：海报展示中心结果：在一项随机，双盲，单剂量递增的I期临床研究（CTR20221413）中，32名健康受试者随机分为5组，分别静脉注射0.3 mg/kg，1 mg/kg，3 mg/kg，6 mg/kg和10 mg/kg。

Safety, pharmacokinetics, and pharmacodynamics (free IgE levels) profile was evaluated. .

评估安全性，药代动力学和药效学（游离IgE水平）概况。。

LP-003 exhibited a non-linear PK characteristic with T1/2 ranging from 44.6 days to 76.5 days, which is approximately 2～3 fold of Omalizumab. Moreover, the free-IgE was suppressed to below detection range for more than 168 days at 1 mg/kg group (except one with high baseline IgE level) to 10 mg/kg group..

LP-003表现出非线性PK特征，T1/2范围为44.6至76.5天，约为奥马珠单抗的2～3倍。此外，在1 mg/kg组（基线IgE水平高的组除外）至10 mg/kg组时，游离IgE被抑制至低于检测范围超过168天。。

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.

LP-003似乎显示出良好的安全性。没有报告3级及以上TEAE，为进一步调查和推进奠定了坚实的基础。

Chronic spontaneous urticaria (CSU) stands as a prevalent skin disorder affecting approximately 1–2% of the global population. Despite SoC treatment, the efficacy and duration of relief remain significant challenges for patients and healthcare providers alike. Anti-IgE therapy was approved as a second-line treatment, however, only approximately 40% of patients achieving complete response following 300 mg Omalizumab dosing.

慢性自发性荨麻疹（CSU）是一种普遍存在的皮肤疾病，约占全球人口的1-2%。尽管进行了SoC治疗，但缓解的疗效和持续时间仍然是患者和医疗保健提供者面临的重大挑战。抗IgE治疗被批准为二线治疗，然而，只有大约40%的患者在服用300 mg奥马珠单抗后达到完全缓解。

Thus, a novel anti-IgE treatments offering higher efficacy and prolonged relief is needed..

因此，需要一种新的抗IgE治疗方法，提供更高的疗效和延长的缓解时间。。

The successful Phase II study of Ligelizumab points a way that anti-IgE antibody with higher IgE affinity and more potent efficacy (FcεRI inhibition) retains the potential to be superior against Omalizumab.

Ligelizumab的成功II期研究指出，具有更高IgE亲和力和更有效功效（FcεRI抑制）的抗IgE抗体保留了优于奥马珠单抗的潜力。

In this study, Longbio Pharma developed a new generation of anti-IgE antibody, LP-003, of higher IgE binding affinity, stronger FcεRI inhibition bioactivity, compared to Omalizumab and even Ligelizumab. Meanwhile, LP-003 has a much longer half-life (approximately 45∽76 days) compared to Omalizumab (approximately 17∽20 days)..

在这项研究中，Longbio Pharma开发了新一代抗IgE抗体LP-003，与奥马珠单抗甚至Ligelizumab相比，具有更高的IgE结合亲和力，更强的FcεRI抑制生物活性。同时，与奥马珠单抗（约17〜20天）相比，LP-003的半衰期更长（约45〜76天）。。

Moreover, a Phase II clinical trial (NCT06228560) of total 200 adult refractory CSU patients, despite up-dosing anti-histamine (H1) treatment, are being enrolled into 5 distinct groups (n=40/group), including three LP-003 treatment groups, one omalizumab treatment group, to provide a head-to-head comparison, and one placebo group.

此外，尽管增加了抗组胺（H1）治疗，但总共200名成人难治性CSU患者的II期临床试验（NCT06228560）被纳入5个不同的组（n=40/组），包括三个LP-003治疗组，一个奥马珠单抗治疗组，以提供头对头比较，一个安慰剂组。

The topline results are expected to be released in early 2025..

最终结果预计将于2025年初发布。。

About LP-003LP-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 and FcεRII/CD23 inhibition), off-target binding and animal study (Tox and efficacy) was conducted.

关于LP-003LP-003，一种新型单克隆抗IgE抗体由奥马珠单抗的发明者兼Tanox的联合创始人Sun Nai chau博士产生，人源化和工程化。基于30多年的IgE靶标研发经验，孙博士开发了新一代抗IgE抗体（LP-003）。其广泛的表征包括：亲和力，生物活性（FcεRI和FcεRII/CD23抑制），脱靶结合和动物研究（Tox和功效）。

LP-003 just accomplished its Phase II study of allergic rhinitis. The current data shows LP-003 has the potential to become a best-in-class treatment..

LP-003刚刚完成了过敏性鼻炎的II期研究。目前的数据表明，LP-003有可能成为同类最佳治疗方法。。

About Longbio PharmaLongBio Pharma is a biotech company located in Shanghai/Changshu, China. The company, which was founded in 2018, focuses on autoimmune and complement diseases, serving patients and society.

关于Longbio Pharma Longbio Pharma是一家位于中国上海/常熟的生物技术公司。该公司成立于2018年，专注于自身免疫和补体疾病，为患者和社会服务。

For more information, please visit: www.longbio.com or please contact: bd@longbio.com.

有关更多信息，请访问：www.longbio.com或联系：bd@longbio.com.

SOURCE Longbio Pharma

来源Longbio Pharma