Breakthrough Interim Phase II Data on LP-003 by Longbio Unveiled at AAAAI 2025

Longbio Unveils Interim Phase II Data for LP-003 in CSU

On March 2, 2025, Longbio Pharma (Suzhou) Co., Ltd. presented groundbreaking interim data for LP-003, a novel long-acting anti-IgE antibody, during the American Academy of Allergy, Asthma, and Immunology (AAAAI 2025) conference. This data focused on Chronic Spontaneous Urticaria (CSU), a common skin disorder affecting approximately 1-2% of the global population.

Longbio's Phase II study, titled 'An interim analysis of Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for CSU,' highlighted significant findings that suggest LP-003 could outperform existing treatments such as Omalizumab. In the clinical trial, LP-003 demonstrated not only an enhanced mean change in UAS7 (urticaria activity score 7) from baseline but also a higher percentage of patients achieving complete resolution of symptoms at both week 4 and week 12 of treatment.

Study Design and Results

The Phase II clinical study was designed as a multi-center, double-blind, placebo-controlled trial. A total of 240 participants were randomized into different arms receiving either LP-003 at various dosing intervals or Omalizumab, the existing standard of care. The primary endpoint measured the rate of patients who achieved UAS7 = 0 after 12 weeks of treatment. Secondary endpoints evaluated the mean change in UAS7 from baseline at weeks 4 and 12.

Although Omalizumab has been the go-to anti-IgE therapy for patients with CSU, results from the trial indicate that LP-003's efficacy is superior. The trial results showed a statistically significant improvement in UAS7 scores, suggesting that LP-003 provides patients with quicker and more sustained relief from CSU symptoms. Noteworthy is the favorable safety profile of LP-003, with no statistically significant differences in adverse events reported between the treatment and placebo groups.

Positioning in the Market

The anticipation surrounding LP-003 is further heightened due to its promising efficacy outcomes, positioning it as a potential best-in-class therapy in the CSU market. Furthermore, LP-003’s dosing regimen, which allows for longer intervals between doses, enhances patient compliance and overall satisfaction with treatment. This could prove pivotal in a market projected to reach $2 billion by 2026 with a CAGR of 8-10% in the subsequent years.

Longbio's LP-003 does not only compete with Omalizumab but also shows efficacy comparable to other emerging therapies like barzolvolimab, developed by Celldex, demonstrating it as a strong contender in the CSU treatment landscape.

Broader Implications for Allergy Treatments

Aside from CSU, Longbio’s advancements with LP-003 also hold potential for applications in other allergic conditions, such as asthma and food allergies. The Chinese National Medical Products Administration (NMPA) has already approved ongoing Phase II trials for asthma with LP-003, marking significant progress for treatment options in allergic diseases. The commercial opportunities are vast since food allergies alone represent a market exceeding $10 billion, with anti-IgE therapy as the only FDA-approved mechanism of action available.

Longbio’s founders, focusing on innovative treatments for autoimmune and rare diseases, are hopeful for LP-003's implications in addressing unmet medical needs for millions of allergy sufferers globally. With this successful Phase II study, Longbio looks towards a future with broader therapeutic options and improved quality of life for patients affected by these chronic conditions.

About Longbio

Founded in 2018 and headquartered in Changshu, China, Longbio is committed to advancing therapies for allergy, respiratory diseases, and other serious conditions. Their focus on developing high-quality biologic medicines aims to bring affordable healthcare solutions to both domestic and international markets. As they progress with LP-003 and their promising portfolio, Longbio is poised to make a lasting impact on the field of allergy and immunology.

For additional information about Longbio and updates on their research, visit their website at www.longbio.com.