A Three-year, Multi-center, Double-blind, Extension Study to Evaluate the Long-term Safety and Efficacy of Ligelizumab in Patients Who Completed Ligelizumab's Phase III Studies in Food Allergy

This is an extension study to evaluate the long-term safety and efficacy of ligelizumab in participants who have completed a ligelizumab Phase III study in food allergy.

Start Date27 Apr 2023

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT04984876

/ TerminatedPhase 3

A 52 Week, Multi-center, Randomized, Double-blind Placebo-controlled Study to Assess the Clinical Efficacy and Safety of Ligelizumab (QGE031) in Decreasing the Sensitivity to Peanuts in Patients With Peanut Allergy

This was a 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled study to assess the safety and clinical efficacy of two dosing regimens of ligelizumab (240 mg and 120 mg) SC q4w (subcutaneous injection every 4 weeks) in participants with a medically confirmed diagnosis of Immunoglobulin E (IgE) mediated peanut allergy.

Start Date07 Dec 2021

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT05024058

/ TerminatedPhase 3

A Multi-center, Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Inducible Urticaria (CINDU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines

This was a placebo controlled, phase 3 study designed to evaluate the efficacy and safety of ligelizumab in participants with chronic inducible urticaria who are inadequately controlled with H1-antihistamines

Start Date16 Nov 2021

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

100 Clinical Results associated with Ligelizumab

100 Translational Medicine associated with Ligelizumab

100 Patents (Medical) associated with Ligelizumab

Literatures (Medical) associated with Ligelizumab

01 Jan 2025·ALLERGOLOGY INTERNATIONAL

Long term safety and efficacy of ligelizumab in the treatment of Japanese patients with chronic spontaneous urticaria

Article

Author: Ichishita, Ryohei ; Takahashi, Hidetoshi ; Severin, Thomas ; Fukunaga, Atsushi ; Burciu, Alis ; Hide, Michihiro ; Tomimatsu, Naoko ; Varanasi, Vineeth ; Hayama, Koremasa ; Fujishige, Ayako ; Hua, Eva ; Sasajima, Takayoshi

BACKGROUND:

In Japan, urticaria is a common skin disorder with chronic spontaneous urticaria (CSU) being the most frequent subtype. This study evaluated the safety of ligelizumab (anti-IgE monoclonal antibody) in Japanese CSU patients.

METHODS:

This was a Phase 3 multicenter, open-label, single-arm 52-week study in adult Japanese patients with CSU inadequately controlled with locally approved doses of H1-antihistamines. The primary objective reported the safety of ligelizumab 120 mg subcutaneously every 4 weeks, by evaluation of treatment emergent adverse events (TEAE). Secondary objectives evaluated efficacy by absolute change from baseline (CFB) in weekly urticaria activity score (UAS7), and the proportion of patients with UAS7 = 0, and dermatology life quality index (DLQI) = 0-1 over time.

RESULTS:

From a total of 66 CSU patients (80.3% females; mean ± SD age 46.4 ± 13.2 years; mean ± SD baseline UAS7 28.7 ± 6.5) enrolled, 53 patients (80.3%) reported ≥1 TEAE during the study, with no severe or serious adverse events, no anaphylaxis events and low frequency of TEAEs leading to treatment discontinuations (6.1%). Absolute mean CFB of UAS7 showed a rapid onset of response at Week 4 (-14.2) with further improvement until end of treatment at Week 52 (-22.9). The proportion of patients achieving UAS7 = 0 improved over time (14.5% at Week 4; 50.0% at Week 52). A sizable proportion of patients achieved DLQI 0-1 with the first dose of ligelizumab (38.5%), and improvements observed throughout the study until Week 52 (68.8%).

CONCLUSIONS:

Treatment with ligelizumab 120 mg was well-tolerated with mild to moderate adverse events and was efficacious in Japanese patients.

01 Oct 2024·EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Time-course and dose-effect of omalizumab in treating chronic idiopathic urticaria/chronic spontaneous urticaria

Article

Author: Ye, Kaihe ; Zhang, Ke ; Zhu, Guanghu ; Zhao, Aiping ; Xu, Zhaosi ; Wang, Zhen ; Gong, Xiao

PURPOSE:

Several studies have shown that subcutaneous injections of omalizumab can treat chronic idiopathic/spontaneous urticaria (CIU/CSU) patients by only assessing the efficacy on specific endpoints. This study aimed to quantitatively analyze different doses of omalizumab in CIU/CSU and compare it with ligelizumab.

METHODS:

Literature searches were performed in PubMed, Embase, and Web of Science databases. A model-based meta-analysis (MBMA) was utilized to develop a model incorporating time since the initiation of treatment and dose for omalizumab, with the change from baseline in Urticaria Activity Score (CFB-UAS7) as the primary efficacy endpoint. The time-course and dose-effect relationship throughout the omalizumab treatment period was analyzed, and the findings were compared with those of the investigational ligelizumab.

RESULTS:

The model equation for the CFB-UAS7 was established as E = -E_max × time/(ET₅₀ + time) × (b₀ + b₁ × dose). The estimated values of the model parameters __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__E max , __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__ ET 50 , __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__b 0 , and __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__b 1 were -1.16, 1.26 weeks, -9.90, and -0.0361 mg^-1, respectively. At week 12 after the first dose, the model-predicted CFB-UAS7 for 150 mg and 300 mg of omalizumab were -16.0 (95% CI, -17.2 to -14.8) and -21.7 (95% CI, -22.9 to -20.5), respectively. In the PEARL-1 trial, the CFB-UAS7 for 72 mg and 120 mg of ligelizumab were -19.4 (95% CI, -20.7 to -18.1) and -19.3 (95% CI, -20.6 to -18.0), respectively. In the PEARL-2 trial, these values were -19.2 (95% CI, -20.5 to -17.9) and -20.3 (95% CI, -21.6 to -19.0), respectively.

CONCLUSION:

Omalizumab showed a significant dose-dependent effect in the treatment of CSU. Both 72 mg and 120 mg ligelizumab might have the potential to outperform 150 mg (but not 300 mg) omalizumab.

01 Jun 2024·Current opinion in allergy and clinical immunology

Role of biologics in severe food allergy

Review

Author: Cafarotti, Arianna ; Dinardo, Giulio ; Miraglia del Giudice, Michele ; Fiocchi, Alessandro ; Artesani, Maria Cristina ; Fierro, Vincenzo ; Indolfi, Cristiana

Purpose of review:

This review examine the dynamic landscape of food allergy treatment within the context of emerging biologics. Our purpose is to comprehensively evaluate the potential benefits, challenges, and transformative impact associated with the utilization of biologics in comparison to conventional therapeutic modalities.

Recent findings:

This document synthesizes recent scientific investigations to various biologics, such as omalizumab, ligelizumab, dupilumab, and tezepelumab, providing a nuanced understanding of their roles in oral immunotherapy, rapid desensitization, and overall food allergy management. Recent studies and clinical trials highlight the impact of anti-IgE treatment on food allergies, revealing critical findings such as dose-related efficacy, facilitation of rapid desensitization in peanut allergies, and the sustained positive outcomes observed in individuals with multifood allergies.

Summary:

The use of biologics presents a groundbreaking approach in the treatment of food allergies. The multifaceted action of these agents, along with their potential to overcome the challenges associated with traditional therapies, marks a significant advancement. Despite the persisting challenges of economic constraints and the need for further safety studies, biologics offer a promising avenue for improving the quality of life for individuals with food allergies. Ongoing research and collaborative efforts are imperative to fully realize the transformative potential inherent in these emerging therapeutic frontiers.

News (Medical) associated with Ligelizumab

26 Nov 2024

·endpts.com

Food allergy biotech Alladapt closes after Phase 3 talks with FDA

Alladapt Immunotherapeutics, a well-financed biotech working in the food allergy field, shut down following talks with the FDA, according to a source familiar with the company. After claiming success in a Phase 1/2 trial in June 2023, Alladapt prepared for a Phase 3 of its experimental food allergy drug. Codenamed ADP101, the oral candidate had received the FDA fast track tag for mono- and multi-food allergies. But a late-stage trial proved too financially daunting. The “FDA guidance for the Phase 3 trial made it economically unviable,” according to the source, who confirmed the company closure to Endpoints News on the condition of anonymity. Investors got a “partial recovery on their investment,” the source added. The Menlo Park, CA-based startup was co-founded in 2018 by CEO Ashley Dombkowski and Kari Nadeau, a former Stanford allergist and now chair of the Department of Environmental Health at Harvard School of Public Health. Dombkowski didn’t respond to an Endpoints inquiry. Alladapt disclosed a $119 million funding round in June 2022 and a $50 million loan with Hercules Capital two months later. The biotech disclosed construction of a manufacturing facility on the outskirts of Philadelphia the year prior. The facility was expected to be completed in “late 2024,” according to architecture and engineering firm Genesis. The company’s investors included Patient Square Capital’s Enavate Sciences, Gurnet Point Capital, AllerFund, Red Tree Venture Capital, Novartis and others. Its equipment was listed for auction in July. Rock Creek Advisors, a firm that works on liquidations and restructurings, lists Alladapt as a client on its website. Some of its top executives left this year for posts at Eccogene and Navigator Medicines . The food allergy space has been through a series of ups and downs in recent years. Nestlé’s attempt to market a peanut allergy drug — known as Palforzia, from its $2.6 billion Aimmune acquisition — had failed commercially. There was a major win in February with the FDA approval of Novartis and Genentech’s Xolair for children and adults with one or more food allergies. Novartis had also axed a peanut allergy Phase 3 trial earlier this year, but said it expected to start a new study of the anti-inflammatory, dubbed ligelizumab, later in 2024. With its ADP101 candidate, Alladapt aimed to deliver small bits of protein from the “big nine” food allergies — milk, eggs, wheat, fish, shellfish, peanuts, tree nuts, soy and sesame — so that patients wouldn’t be as sensitized to the allergens. The startup also terminated an open-label extension study this year. Also in the food allergy space are Leaps by Bayer-backed Ukko and Regeneron, which is testing Dupixent combined with its hematology drug linvoseltamab in Phase 1 .

Phase 3AcquisitionFast TrackPhase 1

15 Nov 2024

·www.pharmaceutical-technology.com

FDA reviews Sanofi and Regeneron’s Dupixent label expansion for urticaria

Chronic spontaneous urticaria is a skin condition characterised by persistent, itchy hives that last six weeks or longer. Credit: wisely via Shutterstock. The US Food and Drug Administration (FDA) has accepted for review the resubmitted supplemental Biologics License Application (sBLA) for Sanofi and Regeneron’s Dupixent (dupilumab) in chronic spontaneous urticaria (CSU). The application seeks to expand Dupixent’s use to treat adults and adolescents (aged 12 and older) with CSU inadequately controlled by H1 antihistamine therapy. The FDA’s target decision date is 18 April 2025. Dupixent, a fully human monoclonal antibody, inhibits the signalling of IL-4 and IL-13 pathways and is different from other immunosuppressants used to treat this condition. The resubmission builds on data from the LIBERTY-CUPID Phase III clinical trial (NCT04180488), which included three studies (Study A, Study B, and Study C). The sBLA adds pivotal results from Study C, conducted in biologic-naive patients with uncontrolled CSU who were receiving standard-of-care antihistamines. Study C met both its primary and key secondary endpoints, demonstrating that Dupixent significantly reduced itch and urticaria activity (hives and itch severity), aligning with earlier results from Study A. Safety data across the LIBERTY-CUPID programme were consistent with Dupixent’s established safety profile, with common adverse events including injection site reactions and Covid-19 infections. Dupixent has already been approved for CSU in Japan and the United Arab Emirates (UAE) and is under regulatory review in the European Union. Outside of Japan and the UAE, the safety and efficacy of Dupixent in CSU remain under evaluation. The potential new indication for CSU comes as Regeneron and Sanofi continue to expand Dupixent’s market presence. In September 2024, the FDA approved Dupixent for chronic obstructive pulmonary disease (COPD), marking its sixth indication and making it the first biologic approved for COPD. Dupixent is also approved for conditions including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis. Dupixent generated $11.3bn (€10.7bn) in global sales in 2023, as per Regeneron’s financials. Projections from GlobalData’s Pharma Intelligence Center suggest revenue could reach $23.6bn by 2030. GlobalData is the parent company of Pharmaceutical Technology. CSU is a skin condition characterised by persistent, itchy hives that last six weeks or longer. While antihistamines and anti-inflammatory treatments are used to manage symptoms, there is an unmet need for more effective options in patients with uncontrolled disease. Meanwhile, Novartis is advancing its CSU pipeline with promising data for its investigational drug, ligelizumab. Results from the Phase III study (NCT03907878) released in May 2024 showed that almost half of patients were completely free of itch and hives as assessed at week 52 using urticaria activity scores. Novartis said it plans to submit ligelizumab for regulatory approval in the second half of 2024.

Clinical ResultDrug ApprovalPhase 3Immunotherapy

12 Mar 2024

·www.prnewswire.com

Longbio Pharma Presented Positive Phase 1 Results for LP-003 at 2024AAD

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

Phase 1Phase 2Clinical ResultAACR

100 Deals associated with Ligelizumab

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KEGG	Wiki	ATC	Drug Bank
D11761	Ligelizumab	-	DB11856

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Food Hypersensitivity	Phase 3	JP	Novartis Pharmaceuticals Corp.	27 Apr 2023
Food Hypersensitivity	Phase 3	AU	Novartis Pharmaceuticals Corp.	27 Apr 2023
Food Hypersensitivity	Phase 3	CA	Novartis Pharmaceuticals Corp.	27 Apr 2023
Food Hypersensitivity	Phase 3	FR	Novartis Pharmaceuticals Corp.	27 Apr 2023
Food Hypersensitivity	Phase 3	DE	Novartis Pharmaceuticals Corp.	27 Apr 2023
Food Hypersensitivity	Phase 3	IT	Novartis Pharmaceuticals Corp.	27 Apr 2023
Food Hypersensitivity	Phase 3	NL	Novartis Pharmaceuticals Corp.	27 Apr 2023
Food Hypersensitivity	Phase 3	ES	Novartis Pharmaceuticals Corp.	27 Apr 2023
Peanut Hypersensitivity	Phase 3	US	Novartis Pharmaceuticals Corp.	07 Dec 2021
Peanut Hypersensitivity	Phase 3	JP	Novartis Pharmaceuticals Corp.	07 Dec 2021

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03907878 (CTgov)	Phase 3	Chronic Urticaria	66	Ligelizumab	tesxafmslp(sxpugnlhdb) = dmvgghilzs gsczpabcfz (gjixkmxhti, woilivbktn - cbtnaigfmz) View more	-	08 Mar 2024
NCT03580369 (CTgov)	Phase 3	Chronic Urticaria	1,072	Ligelizumab (Ligelizumab 72 mg)	ujgsrljukc(jdfpckppdp) = fxxsbtyupp tzqdauyhiy (gjzjmmdhgz, gcqfhuhrnm - belgbazqhn) View more	-	30 Dec 2022
NCT03580369 (CTgov)	Phase 3	Chronic Urticaria	1,072	Ligelizumab (Ligelizumab 120 mg)	ujgsrljukc(jdfpckppdp) = pixaerfgps tzqdauyhiy (gjzjmmdhgz, adhyzkfpea - stykdwqxkx) View more	-	30 Dec 2022
NCT03907878 (Corporate Publications) Manual	Phase 3	Chronic Urticaria	66	ligelizumab	yzlzsnievp(lwzzkofeic) = fbczfevqhd jaqeggipcg (gibbjvizib ) View more	Positive	12 Oct 2022
NCT02477332 \| NCT02649218 (Pubmed \| J Allergy Clin Immunol \| Allergy) Manual	Phase 2	Chronic Urticaria	226	ligelizumab	clccfkfimd(ojtnwfrlhf) = gauwnillne xmjldfjknd (hvuexovmqx ) View more	Positive	13 Nov 2021
NCT03437278 (CTgov)	Phase 2	Chronic Urticaria	49	Ligelizumab (Ligelizumab 24 mg)	sriaigiqsm(xpjauqgyeq) = mlvwjwwjqk dkwszrxkpr (nymshbgwyl, xbcrrbkdcl - bdjedzmfff) View more	-	24 Aug 2021
NCT03437278 (CTgov)	Phase 2	Chronic Urticaria	49	Ligelizumab (Ligelizumab 120 mg)	sriaigiqsm(xpjauqgyeq) = sieruondsj dkwszrxkpr (nymshbgwyl, ktpesjiant - cprztcfpnb) View more	-	24 Aug 2021
NCT02649218 (CTgov)	Phase 2	Chronic Urticaria	226	Ligelizumab	ucztxuxisc(additocoex) = jwrycscvio btypndohtx (houpvpryxq, fxheutaqsj - kwumueobjq) View more	-	14 Aug 2020
NCT02477332 (CTgov)	Phase 2	Chronic Urticaria	382	QGE031 (QGE031 24 mg s.c. q4w)	bxifybeevh(nerlikzclr) = sgisuyiiil mvutflxcuw (tewmvuwhip, nvucydkobb - dtbsenzixr) View more	-	14 Sep 2018
NCT02477332 (CTgov)	Phase 2	Chronic Urticaria	382	QGE031 (QGE031 72 mg s.c. q4w)	bxifybeevh(nerlikzclr) = ntaorcqdry mvutflxcuw (tewmvuwhip, qxqejxxibm - zrdogpokkm) View more	-	14 Sep 2018
NCT02075008 (CTgov)	Phase 2	Allergic asthma	270	QGE031	yxapyapxta(hejrvcmahh) = gdhwtjtnxm hvzzihzyms (anbozilmmc, ygbpuximpk - hxsppbunbz) View more	-	25 Apr 2017
NCT02336425 (CTgov)	Phase 2	Asthma	10	QGE031 (QGE031 240 mg)	txhvghzxlp(lkgoannyhr) = isiuntqltg qyawaounlh (lhkxclinrc, zoxuhrmqee - gldkkjkuxt) View more	-	07 Apr 2017
NCT02336425 (CTgov)	Phase 2	Asthma	10	QGE031 (QGE031 72 mg)	txhvghzxlp(lkgoannyhr) = goiudvjekw qyawaounlh (lhkxclinrc, ccbseswqjj - vbtstaybkq) View more	-	07 Apr 2017
NCT01716754 (CTgov)	Phase 2	Asthma	471	Placebo	ctumnylgir(odwtzdpoob) = mtqgcgermp lvvqybrupc (mledvegwdf, mnnwsiyosn - innxspadkp) View more	-	08 Mar 2017

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