Chemistry:Ligelizumab
Ligelizumab (INN; development code QGE031) is a humanized IgG1 monoclonal antibody designed for the treatment of severe asthma and chronic spontaneous urticaria.[1] It is an anti-IgE that binds to IGHE an acts as an immunomodulator.[2][3] It is delivered as a subcutaneous biologic injection.[4]
This drug was developed by Novartis Pharma AG. Research funded by Novartis Pharma concluded that Ligelizumab was more effective in treating chronic spontaneous urticaria than omalizumab or placebo.[5][6]
In 2021, the US Food and Drug Administration ligelizumab a breakthrough therapy designation for the treatment of patients with chronic spontaneous urticaria who have an inadequate response to H1-antihistamine treatment.[7]
In December 2021, two phase three clinical trials (PEARL 1 and PEARL 2) of ligelizumab in chronic inducible urticaria failed to show superiority versus omalizumab and were terminated.[8][9][10]
In January 2023, a phase three study of ligelizumab in chronic inducible urticaria was terminated after primary endpoints versus omalizumab were not achieved.[11]
In January 2024, a phase three peanut allergy study for ligelizumab was terminated by Novartis.[12]
As of November 2024, the long-term safety and efficacy of ligelizumab in study participants who have completed a ligelizumab Phase III study in food allergy is under investigation.[13]
References
- ↑ Novartis Pharma AG (29 October 2014). "Ligelizumab". Statement On A Nonproprietary Name Adopted By The USAN Council. American Medical Association. https://searchusan.ama-assn.org/usan/documentDownload?uri=/unstructured/binary/usan/ligelizumab.pdf.
- ↑ "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 107". WHO Drug Information 26 (2). 2012. https://www.who.int/medicines/publications/druginformation/innlists/Final_PL107.pdf. Retrieved 2020-10-05.
- ↑ "Looking forward to new targeted treatments for chronic spontaneous urticaria". Clinical and Translational Allergy 7: 1. 2017-01-10. doi:10.1186/s13601-016-0139-2. PMID 28078079.
- ↑ "Novartis Ends Phase III Peanut Allergy Trial in Another Flop for Potential Xolair Successor" (in en-US). 2024-01-18. https://www.biospace.com/novartis-nixes-phase-iii-peanut-allergy-trial-in-another-late-stage-flop-for-potential-xolair-successor.
- ↑ "Ligelizumab for Chronic Spontaneous Urticaria". The New England Journal of Medicine 381 (14): 1321–1332. October 2019. doi:10.1056/NEJMoa1900408. PMID 31577874.
- ↑ Clinical trial number NCT02477332 for "A Multi-center, Randomized, Double-blind, Placebo, and Active-controlled Phase 2b Dose-finding Study of QGE031 as add-on Therapy to Investigate the Efficacy and Safety in Patients With Chronic Spontaneous Urticaria (CSU)" at ClinicalTrials.gov
- ↑ Parsons, Lucy (2021-01-15). "US breakthrough designation for ligelizumab in chronic spontaneous urticaria - PharmaTimes" (in en-US). https://pharmatimes.com/news/us_breakthrough_designation_for_ligelizumab_in_chronic_spontaneous_urticaria_1361362/.
- ↑ Taylor, Nick Paul (2021-12-20). "Novartis suffers shock setback as Xolair successor fails phase 3 | Fierce Biotech" (in en). https://www.fiercebiotech.com/biotech/novartis-suffers-shock-setback-as-xolair-successor-fails-phase-3.
- ↑ Novartis Pharmaceuticals (2023-07-20). A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Safety and Efficacy of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines (Report). clinicaltrials.gov. https://clinicaltrials.gov/study/NCT03580369. Retrieved 2024-11-29.
- ↑ Novartis Pharmaceuticals (2024-02-26). A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines (Report). clinicaltrials.gov. https://clinicaltrials.gov/study/NCT03580356. Retrieved 2024-11-29.
- ↑ Novartis Pharmaceuticals (2024-06-14). 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 (Report). clinicaltrials.gov. https://clinicaltrials.gov/study/NCT05024058. Retrieved 2024-11-29.
- ↑ Novartis Pharmaceuticals (2024-09-13). 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 (Report). clinicaltrials.gov. https://clinicaltrials.gov/study/NCT04984876.
- ↑ Novartis Pharmaceuticals (2024-11-14). 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 (Report). clinicaltrials.gov. https://www.clinicaltrials.gov/study/NCT05678959.
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