Novartis’s Ligelizumab Progresses to Phase III Trial

By Rajaneesh K. Gopinath, Ph.D.

After it’s strong showing in a Phase IIb trial, the monoclonal antibody now moves to the next stage of its development as an effective therapy for chronic spontaneous urticaria (CSU).

Chronic Urticaria is an allergic skin disease that is characterized by the formation of wheals and angioedema. Chronic spontaneous urticaria (CSU) is one of the subtypes of the disease which could occur unpredictably without a trigger. Omalizumab (Xolair), is a prescribed treatment for the condition. It is a humanized monoclonal antibody that binds to Immunoglobulin E (IgE) and reduces allergic symptoms. The drug is used for the treatment of various allergic reactions including Asthma. It is considered a breakthrough drug and was recently recommended by a global guideline as an add-on therapy for CSU patients who are unresponsive to antihistamines. Xolair is marketed all over the world and in the US, it is co-promoted by Novartis Pharmaceuticals and Genentech Inc.

In recent times though, Novartis is developing yet another humanized anti-IgE monoclonal antibody called ligelizumab, for the treatment of allergic and autoimmune diseases. After promising results in a Phase IIb clinical trial comprising 382 patients, it is now advancing to Phase III trials. In the placebo- and active-controlled Phase IIb trial, ligelizumab outperformed omalizumab and met its primary endpoint by demonstrating a clear dose-response relationship. It bound IgE with greater affinity than omalizumab, and this translated into greater therapeutic efficacy. Ligelizumab achieved a rapid onset of action and improved and sustained efficacy. The results were announced at the 27th EADV Congress 2018 in Paris.

On December 4^th, Novartis announced the initiation of multi-center, randomized, double-blind, active- and placebo-controlled Phase III trials – PEARL1 and PEARL 2. More than 2,000 patients will initially be randomized to ligelizumab dose A and B, omalizumab 300mg with the treatment given every 4 weeks for one year. Patients initially randomized to placebo will be switched to ligelizumab dose B starting week 24 until week 52. The primary outcome will measure absolute change from baseline in Urticaria Activity Score (UAS7) at Week 12.

Eric Hughes, Global Development Unit Head, Immunology, Hepatology and Dermatology expressed his excitement. “Novartis is committed to leveraging our strong heritage and expertise in immuno-dermatology to reimagine and discover potential new treatments which can benefit patients,” he said in a statement. “By initiating ligelizumab to Phase III studies we continue to honor that commitment”.

References

1. https://www.novartis.com/news/media-releases/novartis-advances-ligelizumab-qge031-urticaria-phase-iii-basis-strong-phase-ii-head-head-data
2. https://www.mdedge.com/edermatologynews/article/183878/urticaria/ligelizumab-outperformed-omalizumab-refractory-chronic
3. https://www.novartis.com/news/media-releases/novartis-xolairr-recommended-new-global-chronic-urticaria-guideline

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Rajaneesh K. Gopinath