Novartis' Next-Gen Anti-IgE Therapy Ligelizumab (QGE031) Granted Clinical Trial Approval in China for Chronic Inducible Urticaria

China's National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) recently announced on its official website that the QGE031 injection, submitted by Novartis, has received tacit approval for clinical trials, targeting chronic inducible urticaria. Public information shows that ligelizumab (QGE031) is a next-generation IgE antibody therapy currently in Phase 3 clinical trials globally. Previously, this drug was granted Breakthrough Therapy designation by the U.S. FDA for treating chronic spontaneous urticaria with inadequate response to antihistamine therapies.

Screenshot source: CDE official website

According to the "Chinese Urticaria Diagnosis and Treatment Guidelines" (2018 Edition), urticaria is a localized edema reaction caused by the dilation and increased permeability of small blood vessels in the skin and mucous membranes, clinically manifested as wheals of varying sizes accompanied by itching. Chronic urticaria refers to wheals that occur daily or intermittently, and can be divided into chronic spontaneous urticaria and chronic inducible urticaria according to different induction mechanisms. The activation of mast cells induced through immune and non-immune mechanisms is the main pathogenesis of urticaria, where the immune mechanism includes autoimmune reactions against IgE or high-affinity IgE receptors, IgE-dependent type I hypersensitivity reactions, etc.

According to the introduction on Novartis' official website, ligelizumab is a new generation of monoclonal anti-immunoglobulin E (IgE) antibody, which is believed to work by blocking the IgE/FcεRI pathway. The drug is currently being developed for three indications: chronic spontaneous urticaria, chronic inducible urticaria, and food allergy, all of which have entered phase 3 clinical trials.

According to an earlier press release from Novartis, in a Phase 2b dose-finding trial, more patients achieved complete symptom relief with ligelizumab compared to the previous generation of IgE antibodies; in a Phase 2b dose-finding trial involving patients with chronic spontaneous urticaria (CSU) who were not well-controlled by antihistamines, no safety issues were found with ligelizumab compared to the previous generation of IgE antibodies or placebo. Currently, two Phase 3 clinical trials (PEARL 1 and PEARL 2 studies) are ongoing for adolescent and adult CSU patients not adequately controlled by antihistamines, and some primary endpoints have already been met.

According to the information on the ClinicalTrials.gov website, a Phase 3 clinical study (PEARL-PROVOKE study) of ligelizumab is currently underway for adolescent and adult patients with chronic inducible urticaria (CINDU) who are not well-controlled by antihistamines.

We look forward to the smooth progress of Novartis' new generation of IgE antibody therapy in clinical research in China, and hope it can bring more treatment options to patients as soon as possible.

References:

[1] Website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. From https://www.cde.org.cn/main/xxgk/listpage/2f78f372d351c6851af7431c7710a731

[2] Novartis provides an update on Phase III ligelizumab (QGE031) studies in chronic spontaneous urticaria (CSU).Retrieved Dec 20, 2021.From https://www.novartis.com/news/media-releases/novartis-provides-update-phase-iii-ligelizumab-qge031-studies-chronic-spontaneous-urticaria-csu

[3] clinicaltrials.gov official website. From https://clinicaltrials.gov/ct2/show/NCT05024058?term=ligelizumab&draw=2&rank=5

[4] Urticaria Research Center of the Chinese Society of Dermatology and Venereology. (2019). Chinese Guidelines for the Diagnosis and Treatment of Urticaria (2018 Edition). Chinese Journal of Dermatology, doi: 10.3760/cma.j.issn.0412-4030.2019.01.001

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