WASHINGTON, Feb. 25, 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 release of preliminary Phase II data for LP-003, the new generation anti-IgE antibody, at the 2024 American Academy of Allergy, Asthma & Immunology annual meeting (AAAAI 2024)..

华盛顿，2024年2月25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、血液学、眼科和其他自身免疫和罕见疾病的创新蛋白质治疗方法，骄傲地宣布发布LP-003的初步II期数据，新一代抗IgE抗体，在2024年美国过敏，哮喘和免疫学学会年会（AAAAI 2024）上。。

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

Longbio Pharma发布的题为“LP-003的II期研究，一种新型的高亲和力长效抗过敏性鼻炎IgE抗体”的海报标志着会议期间的一个重要时刻。

Title: A Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for allergic rhinitisClinicalTrials.gov ID: NCT06046391Date and Time: February 25, 2024, at 9:45 am (UTC -5)Location: Convention Center, Level 2, Hall DPoster Number: 591Methods: A randomized, double-blind, placebo-controlled Phase II clinical study (NCT06046391), 180 adult patients with moderate to severe seasonal AR despite standard therapy in the previous 2 seasons were randomized to receive LP-003 100mg (n=40), LP-003 200 mg (n=80) or placebo (n=60).

标题：LP-003的II期研究，这是一种针对过敏性鼻炎的新型高亲和力长效抗IgE抗体ClinicalTrials.gov ID:NCT06046391日期和时间：2024年2月25日上午9:45（UTC-5）地点：会议中心，2级，霍尔·德波斯特编号：591方法：一项随机，双盲，安慰剂对照的II期临床研究（NCT06046391），180名成年中度至重度季节性AR患者尽管在前两个季节进行了标准治疗，但随机接受LP-003 100mg（n=40），LP-003 200 mg（n=80）或安慰剂（n=60）。

All patients received concomitant nasal corticosteroids with/without antihistamines as SoC. The primary endpoint was the mean nasal symptom score during the peak pollen period (PPP). Secondary endpoints included mean ocular symptom score, immunogenicity and safety profile etc.Results: the TNSS (mean nasal symptom score) during PPP was significantly lower in the LP-003 groups (3.17±2.17 for 100mg group and 3.45±2.45 for the whole groups) than that in the placebo group (4.25±2.74), with both P values <0.05..

所有患者均接受伴有/不伴有抗组胺药的鼻皮质类固醇作为SoC。主要终点是花粉高峰期（PPP）的平均鼻症状评分。次要终点包括平均眼部症状评分，免疫原性和安全性等。结果：LP-003组在PPP期间的TNSS（平均鼻症状评分）显着低于安慰剂组（100mg组为3.17±2.17，整个组为3.45±2.45）（4.25±2.74），P值均<0.05。。

Meanwhile, LP-003 exhibited a favorable safety profile, with similar incidence of adverse events (AEs) between LP-003 groups and placebo group. The most common AEs (>2% in either group) reported were hyperuricemia, upper respiratory tract infection and nasopharyngitis.

同时，LP-003表现出良好的安全性，LP-003组和安慰剂组之间的不良事件（AE）发生率相似。报告的最常见AE（两组均>2%）是高尿酸血症，上呼吸道感染和鼻咽炎。

Comparing to the first-generation anti-IgE antibody, omalizumab, 100mg LP-003 demonstrate comparable efficacy to 300mg omalizumab in this study. Moreover, subgroup analysis revealed potential superior bioactivity of LP-003 compared to omalizumab using comparable pollen density conditions.

与第一代抗IgE抗体奥马珠单抗相比，100mg LP-003在本研究中显示出与300mg奥马珠单抗相当的功效。此外，亚组分析显示，与使用可比较的花粉密度条件的奥马珠单抗相比，LP-003具有潜在的优越生物活性。

'Anti-IgE therapy has been proven to be effective in AR treatment, however, Omalizumab's dosing regimen has limited its clinical application. This Phase II study shows that 100mg LP-003 significantly improved nasal symptoms (TNSS score) of uncontrolled seasonal allergic rhinitis patients despite SoC treatment.

“抗IgE治疗已被证明在AR治疗中有效，然而，奥马珠单抗的给药方案限制了其临床应用。这项II期研究表明，尽管进行了SoC治疗，但100mg LP-003显着改善了不受控制的季节性过敏性鼻炎患者的鼻症状（TNSS评分）。

In addition, LP-003's fixed and reduced dose promises to alleviate the cost burden on insurance and patients, enhance drug accessibility, and maximize pharmacoeconomic value,' exclaimed by Dr. Sun, Nai-chau, co-founder of Longbio Pharma, also the inventor of omalizumab and co-founder of Tanox Inc. ' AAAAI is recognized as the premier global conference in the field of allergic diseases.

此外，Longbio Pharma联合创始人、奥马珠单抗的发明者兼Tanox Inc.的联合创始人Sun Nai chau博士感叹道，LP-003的固定剂量和减少剂量有望减轻保险和患者的成本负担，提高药物的可及性，并最大限度地提高药物的经济价值。AAAAI被公认为过敏性疾病领域的首要全球会议。

We are honored to unveiled the exciting Phase II results of LP-003, the first registrational clinical trial of anti-IgE antibody for AR conducted in China.'.

我们很荣幸地公布了LP-003的令人兴奋的II期结果，LP-003是中国进行的第一个AR抗IgE抗体注册临床试验。”。

As Longbio Pharma charts its course forward, the successful Phase II study of LP-003 in allergic rhinitis represents a pivotal milestone in advancing the treatment landscape for allergic diseases. With Phase III clinical trials set to commence around 2024 March, the company is poised to continue its legacy of excellence, forge international partnerships, and shape the future of allergy treatment on a global scale..

随着Longbio Pharma的发展，LP-003在过敏性鼻炎中的成功II期研究代表了推进过敏性疾病治疗领域的关键里程碑。随着第三阶段临床试验计划于2024年3月左右开始，该公司准备继续其卓越的传统，建立国际合作伙伴关系，并在全球范围内塑造过敏治疗的未来。。

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, 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）。进行了广泛的表征，包括：亲和力，生物活性，脱靶结合和动物研究（Tox和功效）。

The current data of Phase I and Phase II shows LP-003 is potentially to become a best-in-class treatment..

第一阶段和第二阶段的当前数据表明，LP-003有可能成为同类最佳治疗方法。。

Simultaneously, a Phase II study focusing on chronic spontaneous urticaria (CSU) is underway (NCT06228560), showcasing Longbio Pharma's commitment to exploring diverse therapeutic avenues. The company expects to start the phase III study of allergic rhinitis at 2024 Q1/2, and will get the topline result for LP-003 Phase III study by the end of 2024..

同时，一项针对慢性自发性荨麻疹（CSU）的II期研究正在进行中（NCT06228560），表明Longbio Pharma致力于探索多种治疗途径。该公司预计在2024年第一季度/第二季度开始过敏性鼻炎的III期研究，并将在2024年底前获得LP-003 III期研究的最终结果。。

About Longbio PharmaLongBio Pharma is a biotech company located in Shanghai/Changshu, China. The company, which was founded in 2018, focuses on autoimmune and rare 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，专注于自身免疫和罕见疾病，为患者和社会服务。

LongBio Pharma aims to bring our drugs to both domestic and international markets with our partners, especially to bring patients with more affordable and high-quality bio-medicines. Our leading pipeline is a next generation of anti-IgE antibody (LP-003), which is about to start Phase III study in 2024Q1, and prepare for BLA in 2025H1.

LongBio Pharma的目标是与我们的合作伙伴一起将我们的药物推向国内和国际市场，特别是为患者提供更实惠和高质量的生物药物。我们的主要管道是下一代抗IgE抗体（LP-003），该抗体将于2024Q1开始III期研究，并于2025H1准备BLA。

Another leading pipeline is a bifunctional complement inhibitor (LP-005) , which is in Phase I at present, intending to start Phase II/III in 2024Q2..

另一个主要管道是双功能补体抑制剂（LP-005），目前处于I期，计划在2024Q2开始II/III期。。

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

有关更多信息，请访问：www.longbio.com或联系：[受电子邮件保护]。

SOURCE Longbio Pharma

来源Longbio Pharma