Ligelizumab

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). 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. Title: A Phase 1 study in healthy subjects of LP-003, a novel long-acting, high affinity anti-IgE antibody Abstract Submission ID: 50484 Presentation Time: Mar 8-12, 2024 Location: Poster Exhibits Center Results: 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. Safety, pharmacokinetics, and pharmacodynamics (free IgE levels) profile was evaluated. 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 appears to show good safety profile. No Grade 3 and above TEAE was reported, establishing a solid foundation for further investigation and advancement. 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. Thus, a novel anti-IgE treatments offering higher efficacy and prolonged relief is needed. 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. 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). 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. The topline results are expected to be released in early 2025. About LP-003 LP-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. 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. About Longbio Pharma LongBio 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. For more information, please visit: or please contact: [email protected]. SOURCE Longbio Pharma

Roche and Novartis' Xolair (omalizumab) has become the first medicine cleared in the US for reducing allergic reactions in adults and children as young as 1 year old with at least one food While the monoclonal antibody has been used off-label to treat food allergies, the new approval may help "redefine the way food allergies are managed and reduce the often-serious allergic reactions that can result from exposure to food allergens," said Levi Garraway, chief medical officer of Roche's Genentech unit.Roche estimates there are about 3.4 million children and 13.6 million adults in the US who have been diagnosed with IgE-mediated food allergies, which are triggered by some 160 different foods, and the prevalence has been on the rise for the past two decades.The list price for Xolair ranges from about $2900 a month for children to $5000 a month for adults, according to Genentech. The drug is also approved for severe persistent asthma, chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria.The latest FDA nod is based on data from the NIH-sponsored Phase III OUtMATCH study. It included 471 patients who entered the trial unable to tolerate up to 100mg of peanut protein, and up to 300mg each of milk, egg and cashew protein.Tops placebo across foodsAfter 16 to 20 weeks of treatment, each participant completed four food challenges to assess as the main endpoint their ability to eat a single dose of at least 600mg of peanut protein, the equivalent of about half a teaspoon of regular peanut butter. The primary endpoint was met by 68% patients in the Xolair group, compared to only 5% for placebo, a statistically significant difference.Secondary goals included how they handled a single dose of at least 1000mg of milk, egg or cashew protein without experiencing moderate or severe allergic symptoms. Here, too, Xolair-treated patients were significantly more likely to tolerate these foods.Specifically, 66% of Xolair subjects could tolerate two tablespoons of 1% milk, versus 11% for placebo; 67% tolerated one-quarter of an egg versus 0% with placebo; and 42% could consume 3.5 cashews without suffering moderate-to-severe reactions, compared to 3% for placebo. Roche cautioned that while patients in the OUtMATCH study managed these small amounts of food, Xolair should still be used with ongoing avoidance food allergens.The most common adverse events in Xolair-treated patients were injection-site reactions and fever. More results from the study will be shared at the upcoming American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting later this month.Novartis recently halted a Phase III trial of its experimental peanut allergy treatment ligelizumab (QGE031) due to ongoing optimisation of the drug's food allergy clinical programme. A company spokesperson said it is looking to test the optimised dosing in a new pivotal Phase III trial starting in the third quarter.