GlobeNewswire by notified

Novartis provides an update on Phase III ligelizumab (QGE031) studies in chronic spontaneous urticaria (CSU)

Share

Ad hoc announcement pursuant to Art. 53 LR

  • Ligelizumab, a high-affinity anti-IgE antibody, demonstrated superiority compared with placebo at Week 12 in Phase III PEARL 1 and PEARL 2 trials, but not versus omalizumab1
  • Novartis is continuing to evaluate the PEARL data and will provide an update in due courseas well as next steps for the program

Basel, December 20, 2021 – Novartis today announced top-line results from PEARL 1 and PEARL 2 Phase III studies in chronic spontaneous urticaria (CSU), which showed that the studies met their primary endpoints of superiority for ligelizumab versus placebo at Week 12, but not versus omalizumab1.

“We are disappointed that we have been unable to demonstrate superior efficacy for ligelizumab versus standard of care in the treatment of CSU,” said John Tsai, M.D., Head of Global Drug Development and Chief Medical Officer, Novartis. “We will continue to evaluate the potential for ligelizumab to bring benefit to patients in the areas of chronic inducible urticaria (CIndU) and food allergy, where there is significant unmet need.”

Full PEARL 1 and 2 Phase III data will be made publicly available after study completion in the second half of 2022.

CSU is an unpredictable, systemic skin disease, characterized by the spontaneous and recurrent appearance of itchy, painful hives (wheals) on the skin, angioedema or both for at least 6 weeks2,3 and affects up to 1% of the population at any one time2. Approximately 60% of patients do not achieve complete control with first-line treatment antihistamines4-7.

Novartis recently began Phase III studies for remibrutinib (LOU064), a highly selective, potent oral BTK inhibitor that has previously shown rapid and effective CSU disease control8,9.

Novartis in chronic spontaneous urticaria (CSU)
Novartis is dedicated to reimagining the care of patients with diseases that can severely limit quality of life such as CSU, psoriasis, acne and atopic dermatitis. Novartis is committed to developing medicines that will advance the treatment of CSU, so patients are able to live their lives without the distressing and unpredictable symptoms of this debilitating disease10. These include ligelizumab (QGE031) a high-affinity monoclonal anti-immunoglobulin E antibody and remibrutinib (LOU064), a highly selective, potent oral Bruton’s tyrosine kinase (BTK) inhibitor with a potential best-in-class profile for the treatment of autoimmune disorders. Any new therapies will add to our portfolio of medicines that already includes Xolair® (omalizumab), our existing approved therapy for CSU.

About ligelizumab
Ligelizumab (QGE031) is a high-affinity, monoclonal anti-immunoglobulin (Ig) E antibody. In a Phase IIb dose-finding trial, more patients experienced complete resolution of wheals (hives) with ligelizumab compared with Xolair® (omalizumab)11.

About PEARL 1 and PEARL 2
PEARL 1 and PEARL 2 (NCT03580369 and NCT03580356) are two identically designed Phase III, multicenter, randomized, double-blind, active- and placebo-controlled, parallel-group studies12,13. The twin studies are designed to establish efficacy and safety of ligelizumab in adult and adolescent patients (≥12 years of age) with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1-antihistamine treatment by demonstrating better efficacy over placebo and Xolair® (omalizumab)12,13. More than 2,000 adult and adolescent patients across 48 countries were randomized to ligelizumab 72 mg, ligelizumab 120 mg, omalizumab 300 mg or placebo with treatment given every 4 weeks for 1 year12-14. Patients initially randomized to placebo were switched to ligelizumab 120 mg from Week 24 until the end of the 52-week treatment period. The primary outcome measured the change from baseline in Urticaria Activity Score over 7 days (UAS7) at Week 1212-14.

Disclaimer
This press release 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,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” “dedicated,” “continuing,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for ligelizumab, or regarding potential future revenues from ligelizumab. 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 ligelizumab 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 ligelizumab will be commercially successful in the future. In particular, our expectations regarding ligelizumab 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, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity 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 press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library
For questions about the site or required registration, please contact media.relations@novartis.com

References

  1. Novartis Data on File.
  2. Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report. Allergy. 2011;66:317-330.
  3. Vestergaard C and Deleuran M. Chronic spontaneous urticaria: latest developments in aetiology, diagnosis and therapy. Ther Adv Chronic Dis. 2015;6:304-13.
  4. Zuberbier T, Latiff A, Abuzakouk M, et al. The international EAACI/GA2LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. Published 2021 Sept 18. doi:10.1111/all.15090.
  5. Kaplan AP. Chronic Spontaneous Urticaria: Pathogenesis and Treatment Considerations. Allergy Asthma Immunol Res. 2017;9(6):477-482. doi:10.4168/aair.2017.9.6.477
  6. Maurer M, Costa C, Gimenez Arnau A, et al. Antihistamine- resistant chronic spontaneous urticaria remains undertreated: 2-year data from the AWARE study. Clin Exp Allergy. 2020;50(10):1166-1175. doi:10.1111/cea.13716.
  7. Guillén-Aguinaga S, Jáuregui Presa I, Aguinaga-Ontoso E, Guillén-Grima F, Ferrer M. Updosing nonsedating antihistamines in patients with chronic spontaneous urticaria: a systematic review and meta-analysis. Br J Dermatol. 2016;175(6):1153-1165. doi:10.1111/bjd.14768.
  8. Clinical Trials.gov. A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines (REMIX-1). NCT05030311. Available from: https://clinicaltrials.gov/ct2/show/NCT05030311. [Last accessed: December 2021].
  9. Clinical Trials.gov. A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1- Antihistamines. NCT05032157. Available from: https://clinicaltrials.gov/ct2/show/NCT05032157. [Last accessed: December 2021].
  10. Weller K, Maurer M, Grattan C, et al. ASSURE-CSU: a real-world study of burden of disease in patients with symptomatic chronic spontaneous urticaria. Clin Transl Allergy. 2015;5:29.
  11. Maurer M, Giménez-Arnau AM, Sussman G, et al. Ligelizumab for Chronic Spontaneous Urticaria. N Engl J Med. 2019;381:1321-1332.
  12. ClinicalTrials.gov. NCT03580369. A Phase III Study of the Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled with H1-antihistamines [online] April 2020. Available from: https://clinicaltrials.gov/ct2/show/NCT03580369 [Last accessed: December 2021].
  13. ClinicalTrials.gov. NCT03580356. A Phase III Study of the Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled with H1-antihistamines [online] March 2020. Available from: https://clinicaltrials.gov/ct2/show/NCT03580356 [Last accessed: December 2021].
  14. Severin T, Maurer M, Giménez-Arnau A, et al. Ligelizumab versus omalizumab in CSU: Phase 3 design and rationale. Presented at the 4th GA²LEN Global Urticaria Forum; December 5–6 2018; Berlin, Germany.

# # #

Novartis Media Relations
E-mail: media.relations@novartis.com

Michael Meo
Novartis Global Media Relations
+1 862 274 5414 (mobile)
michael.meo@novartis.com



Julie Masow
Novartis US External Communications
+1 862 579 8456
julie.masow@novartis.com
Louise Clark
Novartis Global Communications
+41 79 123 8172 (mobile)
louise.clark@novartis.com

Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com

Central North America
Samir Shah +41 61 324 7944 Sloan Simpson +1 862 345 4440
Thomas Hungerbuehler +41 61 324 8425 Alina Levchuk +1 862 778 3372
Isabella Zinck +41 61 324 7188 Parag Mahanti +1 973-876-4912
To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Scandinavian Tobacco Group A/S: Transactions in connection with share buy-back programme17.1.2022 09:15:00 CET | Press release

Company Announcement No. 3/2022 Copenhagen, 17 January 2022 Transactions in connection with share buy-back programme On 10 March 2021, Scandinavian Tobacco Group A/S (“STG”) announced that a share buy-back programme of an aggregated price of up to DKK 600 million was launched with the purpose to adjust the Company’s capital structure and meet obligations relating to the Group’s share-based incentive programme. The buy-back programme is executed in accordance with Regulation No. 596/2014 of the European Parliament and Council of 16 April 2014 (the “Market Abuse Regulation”) and Commission Delegated Regulation (EU) 2016/1052, also referred to as the Safe Harbour rules. The share buy-back programme will end no later than 28 February 2022. The following transactions have been executed from 10 January to 14 January 2022: Number of sharesAverage purchase price, DKKTransaction value, DKKAccumulated, last announcement4,015,833513,137,59110 January 202221,758137.472,990,98111 January 202214,980

Stolt-Nielsen Limited to Host a Video Conference to Present the Fourth Quarter and Full Year 2021 Results17.1.2022 09:00:00 CET | Press release

LONDON, January 17 , 2022 – Stolt-Nielsen Limited (Oslo Børs: SNI) will host a video conference to present the Company’s unaudited results for the fourth quarter and full year 2021 on Thursday, January 27, 2022 at 14:00 CET (08:00 EST, 13:00 GMT). The presentation and video conference will be hosted by: - Mr. Niels G. Stolt-Nielsen - Chief Executive Officer, Stolt-Nielsen Limited - Mr. Jens F. Grüner-Hegge - Chief Financial Officer, Stolt-Nielsen Limited - Mr. Lucas Vos - President, Stolt Tankers Those who wish to watch the live broadcast may access it here The presentation will be published on our website: https://www.stolt-nielsen.com/en/investors/reports-presentations/ For additional information please contact: Jens F. Grüner-Hegge Chief Financial Officer UK +44 (0) 20 7611 8985 j.gruner-hegge@stolt.com Ellie Davison Head of Corporate Communications UK +44 (0) 20 7611 8926 e.davison@stolt.com About Stolt-Nielsen Limited Stolt-Nielsen Limited (SNL or 'the Company') is a long-term inv

Jetex & Berlin Neuhardenberg Airport to Develop the World’s First Pure Green FBO in Berlin17.1.2022 08:30:49 CET | Press release

Dubai, United Arab Emirates, Jan. 17, 2022 (GLOBE NEWSWIRE) -- Jetex, an award-winning global leader in executive aviation, and Berlin Neuhardenberg Airport announce the signing of a Joint Venture Agreement whereby both parties will work towards the development of a world-class executive aviation terminal and fixed base operation at Berlin Neuhardenberg Airport (EDON). Berlin is one of the top ten private aviation markets in Europe with more than 20,000 annual executive jet movements. “FBO Berlin Neuhardenberg” Special Purpose Vehicle (SPV) to be established in 50-50 joint venture shareholding partnership between Jetex and Berlin Neuhardenberg Airport. Jetex investment subject to certain conditions precedent being met by Berlin Neuhardenberg Airport. Private aviation aircraft operators and owners will benefit from a world-class dedicated FBO that will serve the Berlin, East Germany and Polish border market, offering the highest quality levels of hospitality, service, security and priva

Mika Salokangas appointed as a member of Telko Board of Directors17.1.2022 07:45:00 CET | Press release

Aspo Plc Stock Exchange Release January 17, 2022, at 8.45 a.m. Mika Salokangas appointedas a member of Telko Board of Directors Starting from February 1, 2022, Mika Salokangas, M. Sc. (Econ.), has been appointed to the Board of Directors of Telko Ltd, part of Aspo Group. Previously, Salokangas has served as Managing Director of Ahlsell Oy, as Vice President and in several management positions of Wihuri Oy and as the Managing Director of Agora Networks Oy and Oy Saab-Auto Ab. "I am very pleased that Mika Salokangas will start as a member of Telko's Board of Directors. His diverse background in demanding corporate management positions, and especially Mika's acquisition experience as Ahlsell’s Managing director for more than 10 years, fits well with Telko's compounder strategy," says Rolf Jansson, CEO of Aspo Group. Telko Ltd is an international leading expert in and supplier of plastic raw materials, industrial chemicals, and lubricants. Telko’s operations are based on representing the b

Sampo plc’s share buybacks 14/01/202217.1.2022 07:30:00 CET | Press release

SAMPO PLC STOCK EXCHANGE RELEASE 17/01/2022 at 08:30 am Sampo plc’s share buybacks 14/01/2022 On 14/01/2022 Sampo plc (business code 0142213-3, LEI 743700UF3RL386WIDA22) has acquired its own A shares (ISIN code FI0009003305) as follows: Sampo plc’s share buybacksAggregated daily volume (in number of shares)Daily weighted average price of the purchased shares*Market (MIC Code)17,15044.90AQEU21,65444.90CEUX3,47644.90TQEX88,05144.93XHELTOTAL130,33144.92 *rounded to two decimals On 1 October 2021, Sampo announced a share buyback programme of up to a maximum of EUR 750 million in compliance with the Market Abuse Regulation (EU) 596/2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052. The programme, which started on 4 October 2021, is based on the authorization granted by Sampo's Annual General Meeting on 19 May 2021. After the disclosed transactions, the company owns in total 9,776,009 Sampo A shares representing 1.76 per cent of the total number of shares in Sampo plc. Detail

Telenor Group agrees to sell its stake in Wave Money to Yoma Strategic17.1.2022 01:16:32 CET | Press release

(Singapore/Oslo, 17 January 2022) Telenor Group and Yoma Strategic have entered into an agreement to sell Telenor Group’s 51 percent share of Digital Money Myanmar Limited (“Wave Money”) for USD 53 million to Yoma MFS Holdings Pte. Ltd, a subsidiary of Yoma Strategic. This subsidiary is to be funded by a consortium of investors led by Yoma Strategic which remains subject to completion and final funding. When the transaction is concluded, Yoma Strategic will become the largest and controlling shareholder of Wave Money, ensuring that the company continue operations and further extend its leading role in Myanmar’s fintech sector. Wave Money is a leading provider of money transfer and digital payment solutions in Myanmar. The company was launched in November 2016 as a joint venture between Yoma Bank and Telenor Group, after the fintech pioneer was awarded a license to become the first non-bank institution to work under Myanmar's new Mobile Financial Services Regulation. In 2020, Wave Money

Telenor Group selger sin eierandel i Wave Money til Yoma Strategic17.1.2022 01:16:32 CET | Pressemelding

(Singapore/Oslo, 17. januar 2022) Telenor Group og Yoma Strategic har inngått en avtale om et salg av Telenors 51 prosents eierandel i Digital Money Myanmar Limited («Wave Money») for USD 53 millioner (rundt NOK 470 millioner) til Yoma MFS Holdings Pte. Ltd, et datterselskap av Yoma Strategic. Datterselskapet finansieres av et konsortium ledet av Yoma Strategic, og transaksjonen forutsetter endelig ferdigstillelse av denne finansieringen. Når salget er gjennomført vil Yoma Strategic bli den største og kontrollerende eier av Wave Money og sikre at selskapet fortsetter operasjonen og utvikler sin ledende rolle i Myanmars fintech sektor. Selskapet ble etablert i november 2016 som et joint venture mellom Yoma Bank og Telenor Group. Wave Money er en ledende leverandør av finansielle tjenester og digitale betalingsløsninger i Myanmar. Selskapet ble lansert i november 2016 som et fellesforetak mellom Yoma Bank og Telenor Group, etter at selskapet ble som første ikke-bankinstitusjon tildelt li