Marcus Maurer, ECARF expert and allergy specialist at Charité, and his team published this finding in October 2019. The new drug is called ligelizumab.

At the annual congress of the European Academy of Allergy and Clinical Immunology (EAACI) in June 2020, Maurer presented additional results from the study: As many as 57% of patients had no symptoms after 52 weeks of treatment with ligelizumab. The patients were administered the drug at a dose of 240 mg.

Ligelizumab is a so-called monoclonal antibody that binds to immunoglobulin E (IgE). IgE is one of the factors behind the symptoms of patients with chronic urticaria.

The drug

A precursor drug, the antibody omalizumab, has already been approved. According to guidelines, its use is recommended when high-dose antihistamines fail to bring symptoms under control.

Ligelizumab also works in patients with chronic hives who do not respond to omalizumab, said Maurer.

He also provided a possible explanation as to why ligelizumab is more effective: The binding of ligelizumab to IgE is 88-fold stronger than that of omalizumab. The binding lasts longer, and therefore the duration of action of the new drug is also longer.

The study

In the core study, 382 patients received either

• subcutaneously injected ligelizumab, or
• omalizumab, which is already available for the treatment of urticaria, or
• a placebo (a preparation with no active ingredient).

The team also investigated different doses of ligelizumab and single-dose versus multiple-dose treatment.

The doctors monitored the symptoms of the study patients every week for skin rash (itchy hives) and angiooedema, or swelling of the skin and mucosa. If these symptoms occur repeatedly over a period of more than six weeks without a clear trigger, it is referred to as chronic spontaneous urticaria (CSU).

In over half of the patients who received ligelizumab at a dose of 72mg, the rash disappeared completely; a higher dosage did not lead to better results. Only one in four patients who received omalizumab remained symptom-free. There was no change at all in the symptoms of the patients who received the placebo. “This is a very important study because it shows that, in the treatment of patients with chronic urticaria, ligelizumab is more effective than omalizumab, the only previously approved medication for this disease other than antihistamines”, said Maurer.

Current situation

The research team is currently in the final phase of preparing the drug for approval. This involves two phase III trials, each of which includes more than 1,000 patients from many different clinics. The studies have now started again after a delay due to the pandemic in spring 2020. Patients are currently being recruited for a third phase III study.

Sources

Gasser P et al. The mechanistic and functional profile of the therapeutic anti-IgE antibody ligelizumab differs from omalizumab. Nat Commun. 2020;11(1):165.

Maurer M et al. Ligelizumab for chronic spontaneous urticaria. New England Journal of Medicine Oct 2019. doi: 10.1056/NEJMoa1900408

Maurer M et al. Ligelizumab (anti-IdE) in chronic spontaneous urticaria. Presentation at the EAACI Digital Congress of the European Academy of Allergy and Clinical Immunology, 6 June 2020.