Novartis confidently breaks out mid-stage data on Xolair competitor
Late last year, Novartis indicated its experimental therapy ligelizumab was Phase III ready after it outperformed Xolair — the company’s Roche-partnered chronic spontaneous urticaria therapy that has lost patent protection — in a Phase II study. On Tuesday, the Swiss drugmaker broke out some of the mid-stage data that triggered its confidence.
In the 382-patient trial, patients were either given ligelizumab at a dose of 24 mg, 72 mg, or 240 mg, omalizumab (Xolair) at a dose of 300 mg, or placebo, administered subcutaneously every 4 weeks for a period of 20 weeks, or a single 120-mg dose of ligelizumab. Patients in the study were already on antihistamines.
At week 12, a total of 30%, 51%, and 42% of the patients treated with 24 mg, 72 mg, and 240 mg, respectively, of ligelizumab had complete control of hives, versus 26% of the patients in the omalizumab group and no patients in the placebo group — suggesting a dose-response relationship.
In addition, about 30%, 44%, and 40% of the patients treated with 24 mg, 72 mg, and 240 mg, respectively, of ligelizumab had complete control of symptoms, versus 26% of the patients in the omalizumab group and no patients in the placebo group.
The blockbuster biologic Xolair, which is approved for chronic spontaneous urticaria (CSU) as well as allergic asthma, is vulnerable to competition after losing patent protection, particularly in the United States and Europe.
“Around half of patients on current standard-of-care treatment, including omalizumab, for CSU continue to have uncontrolled symptoms,” said Eric Hughes, Novartis’ global development unit head for immunology, hepatology and dermatology, in a statement.
Both Novartis $NVS and Roche $RHBBY have contingency plans in place for eventual Xolair competition in patients with chronic spontaneous urticaria (CSU), an unpredictable skin condition that is characterized by spontaneous swelling and itchy hives. Novartis has ligelizumab, while Roche is developing a BTK inhibitor, fenebrutinib, which it is currently being tested in a Phase II CSU trial. A host of drugmakers are also working on rival treatments.
Ligelizumab, meanwhile, is currently being investigated in an ongoing late-stage program which includes twin Phase III trials PEARL 1 and PEARL 2 that are recruiting more than 2,000 patients.