Oct 08, 2019
  • Results from a Phase IIb dose-finding study show an average complete response rate of 42% for doses 240 mg and 72 mg ligelizumab at Week 12 compared with 26% for those taking 300 mg Xolair’s dose (omalizumab)[1]
  • Complete control of hives achieved by 51% and 42% of patients treated with ligelizumab (72 mg and 240 mg respectively) at Week 12 compared with 26% of patients treated with Xolair[1] 300 mg
  • Ligelizumab (QGE031), a monoclonal antibody, blocking the IgE/FceR1 pathway, is being developed as a treatment option for chronic spontaneous urticaria (CSU) patients whose symptoms are inadequately controlled by H1-antihistamines[2]
  • Ligelizumab (QGE031) is currently being investigated in an ongoing Phase III clinical trial program which includes Phase III trials PEARL 1 and PEARL 2 that are globally recruiting more than 2,000 patients across 48 countries around the world[3][4]
  • Data from the Phase IIb dose-finding study were published in The New England Journal of Medicine[1]

Basel, October 8, 2019 – “These study results are encouraging as we look to support patients with effective treatments to manage the debilitating symptoms of CSU,” said Marcus Maurer, MD, professor of dermatology and allergy and director of research at the Department of Dermatology and Allergy, Allergie-Centrum-Charité of the Charité–Universitätsmedizin in Berlin, Germany. “CSU is a severe skin disease that significantly impacts the lives of patients, who may experience unpredictable and persistent itchy hives, sometimes with painful swelling of the skin."

“Around half of patients on current standard-of-care treatment, including omalizumab, for CSU continue to have uncontrolled symptoms[5],” said Eric Hughes, Global Development Unit head for Immunology, Hepatology and Dermatology. “We’re encouraged by the results of this study, which is a step forward in our journey to reimagine care in immuno-dermatology to bring better treatment options for patients.”

This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.

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[1] Maurer M, et al. Ligelizumab for chronic spontaneous urticaria.  N Engl J Med 2019; 381:1321-1332.
[2] Maurer M, et al. Ligelizumab as add-on therapy for patients with H1-antihistamine-refractory chronic spontaneous urticaria: Primary results of a placebo- and active-controlled phase 2b dose finding study. Poster presented at the 2018 European Academy of Allergy and Clinical Immunology Congress; 26–30 May, 2018; Munich, Germany. Poster: 1828.
[3] ClinicalTrials.gov. A Phase III Study of Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines. Available online at: https://clinicaltrials.gov/ct2/show/NCT03580369. Last accessed October 2018
[4] ClinicalTrials.gov. A Phase III Study of Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines. Available online at: https://clinicaltrials.gov/ct2/show/NCT03580356. Last accessed October 2018.
[5] Kaplan AP. Chronic Spontaneous Urticaria: Pathogenesis and Treatment Considerations. Allergy Asthma Immunol Res 2017;9:477–483.

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