LongBio Showcases Promising Phase I Data of LP-003, a Next-Gen Anti-IgE Antibody, at ERS 2023

From June 18 to 22, 2023 (Bulgarian time), the European Rhinologic Society Congress 2023 / International Conference on Allergy and Infection of the Nose / World Rhinology Congress was held in Sofia, the capital of Bulgaria. During the conference,Dr. Liu Heng, General Manager of LongBio, was invited to deliver an oral presentation on the Phase I clinical data of LongBio’s LP-003 at the conference.Meanwhile, the poster submitted by LongBio, “A Phase 1 study in healthy subjects of LP-003, a novel long-acting anti-IgE antibody for allergic rhinitis,” was selected by the conference asbest poster。

At this conference, the company publicly disclosed partial research findings from the Phase I clinical trial of LP-003 for the first time, with its clinical data further corroboratingLP-003 features enhanced potency, safety, low dosage, and ultra-long duration of action, with the potential to become a best-in-class therapy.. The invitation from the Organizing Committee of the European Rhinologic Society to deliver an oral presentation, along with the selection as a Best Poster, further demonstrates the recognition by leading academic institutions of the Phase I clinical study results of LongBio’s LP-003 and their expectations for its future commercialization.

In the single-dose pharmacokinetic (PK) study, the half-lives for the 1.0 mg/kg, 3.0 mg/kg, 6.0 mg/kg, and 10.0 mg/kg dose groups were approximately 44.6 days, 65.2 days, 76.5 days, and 75.6 days, respectively. In comparison, omalizumab, the first-generation anti-IgE monoclonal antibody developed by Dr. Sun, which achieved global sales of $3.6 billion in 2022, demonstrated a half-life of 17.1–20.4 days in clinical studies involving healthy Japanese subjects. In the pharmacodynamic (PD) study, IgE suppression in subjects lasted for 42 days in the 1.0 mg/kg dose group, while in the 3.0 mg/kg and higher dose groups, IgE suppression persisted for more than 168 days, significantly exceeding the approximately 14 days observed with omalizumab. Compared to competing products, LP-003 has the potential to achieve significant improvements in efficacy, dosage, and dosing frequency.

In terms of safety, no adverse events of Grade 3 or higher were observed with LP-003. Anti-drug antibodies (ADA) were detected in 3 out of 60 subjects.

Dr. Sun Naichao, co-founder of LongBio, is the principal inventor of first-generation anti-IgE antibodies. LP-003 is a next-generation anti-IgE antibody developed by Dr. Sun based on his profound and unique understanding of the IgE target accumulated over more than three decades. LP-003 has currently entered Phase II clinical trials, with allergic rhinitis as its first indication. Allergic rhinitis is a common chronic condition in clinical practice; tens of millions of patients in China alone face limited efficacy from conventional pharmacological treatments. There is an urgent clinical need for a medication with superior efficacy and better patient compliance.

LongBio will continue to advance the clinical development of LP-003 and actively expand its indications into broader allergic conditions, such as chronic urticaria and asthma, to seek better treatment options and solutions for patients, thereby improving their quality of life and reducing their burden.

European Rhinologic Society Congress / International Conference on Inflammation and Allergy of the Nose / International Rhinologic Congress

The European Rhinologic Society (ERS) Congress, the International Symposium on Inflammation and Allergy of the Nose (ISIAN), and the International Rhinologic Society (IRS) Congress constitute the world’s leading conferences in rhinology. Previous editions have attracted more than 1,800 delegates from over 80 countries worldwide, including rhinologists, otolaryngologists, allergists, immunologists, skull base surgeons, facial plastic surgeons, primary care physicians, scientists, and allied health professionals. The five-day ERS Congress will offer attendees opportunities to exchange knowledge and learn from global colleagues in rhinology, allergy, plastic surgery, and related fields through plenary sessions, symposia, educational meetings, roundtable discussions, debates, and workshops.

LongBio Pharma (Suzhou) Co., Ltd. is a biotechnology company dedicated to the research and development of innovative large-molecule drugs. Its founders and management team possess extensive overseas study and work experience, representing highly renowned high-tech talents in the biomedical industry with long-standing track records of excellence. The team demonstrates comprehensive capabilities across the entire drug R&D value chain and project management. The company has established R&D laboratories and pilot-scale production workshops spanning over 2,000 square meters, enabling development capabilities from early-stage research and pilot production through to Phase II clinical trials. To date, the company has secured financing exceeding RMB 100 million.

The Company boasts three innovative biologic drug technology platforms, with its R&D pipeline focused on the dual tracks of “allergy and complement,” covering autoimmune diseases in respiratory, dermatological, nephrological, and rare disease indications. It will continue to advance the development of innovative biologics to deliver more affordable and higher-quality medicines to patients worldwide.

For more information, please visit the company's official website.www.longbio.com. Or send an email to bd@longbio.com