Business Wire

New Subgroup Analysis of the Phase 3 OPTIMUM Study Demonstrates the Benefits of PONVORYTM▼ (ponesimod) Over teriflunomide in Early Disease Multiple Sclerosis

Share

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from a new subgroup analysis of the pivotal Phase 3 OPTIMUM trial. Featured as an e-poster at the 37th Congress of the European Committee for Treatment Research in Multiple Sclerosis (ECTRIMS) from October 13-15, the subgroup analysis showed that in the expanded disability status scale (EDSS) ≤ 3 subgroup, ponesimod significantly reduced annualised relapse rate (ARR) by 47 percent (rate ratio [RR] = 0.53; 99 percent confidence levels [CLs]: 0.372, 0.755; p<0.0001) and MS-fatigue was statistically significantly lower in the ponesimod group compared with the teriflunomide group at week 108, with a mean difference (MD) of -4.31 (95 percent CLs: -6.99, -1.63; p=0.0017).1,2

“Multiple sclerosis is a debilitating and degenerative disease for which there is no cure, so our current focus is on preventing progression and minimising relapses,” said Allitia DiBernardo, M.D., lead author of the e-poster and Global Medical Affairs Head, Neurology, Janssen Global Services, LLC. “The OPTIMUM subgroup analysis supports the principle of early treatment intervention with high potency therapies such as ponesimod, which aims to reduce relapse rates, improve patient outcomes and ultimately contribute to a better quality of life for people living with MS.”

The OPTIMUM study subgroup analysis randomised 1,133 patients (ponesimod, n = 567; teriflunomide, n = 566) and examined those with EDSS ≤ 3 (up to moderate disability in one function, or mild disability in 3 or 4 functions; no impairment to walking) and/or who were treatment naïve.1

The analysis showed that in treatment-naïve patients, ponesimod significantly reduced ARR (RR = 0.714; 99 percent CLs: 0.486, 1.049; p=0.0241) and MS-fatigue was significantly lower in the ponesimod group compared with the teriflunomide group at week 108, MD = -5.30 (95 percent CLs: -8.25, -2.35; p=0.0004).1,2

Results from this subgroup analysis for combined unique active lesions (CUALs) were consistent with the overall population. Patients significantly benefited from ponesimod compared with teriflunomide in both the EDSS ≤3 (RR = 0.424; 95 percent CLs: 0.329, 0.546; p<0.0001) and treatment-naïve (RR = 0.411; 95 percent CLs: 0.310, 0.545; p<0.0001) groups.1,2

“These data represent a significant contribution towards our goal of making a positive impact for people living with MS,” said Tamara Werner-Kiechle, M.D., Therapeutic Area Lead Neuroscience & Pulmonary Hypertension, Europe, Middle East and Africa (EMEA), Janssen Cilag GmBH. “The further research on ponesimod is testimony to our commitment to support people living with MS, with a particular focus on improving the treatment landscape in relapsing MS, where medical unmet needs among the MS community remain.”

#ENDS#

About Multiple Sclerosis
MS is a chronic autoimmune inflammatory disease of the central nervous system (CNS) in which immune cells attack myelin (the protective casing that insulates nerve cells), damaging or destroying it and causing inflammation.3 This affects how the CNS processes information and communicates with the rest of the body, causing the neurologic signs and symptoms of MS.4 Symptoms vary by person, but common symptoms include fatigue, balance and walking problems, numbness or tingling, dizziness and vertigo, vision problems, bladder and bowel problems and weakness.4,5,6

About PONVORYTM (ponesimod)
Ponesimod is a daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, indicated for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features.7,8 Ponesimod is believed to work by keeping immune cells called lymphocytes out of the blood by trapping them in the lymph nodes and out of the central nervous system, where they could cause damage.8

Ponesimod does not require genetic testing or first-dose cardiac monitoring for most patients. Because initiation of ponesimod treatment results in a decrease in heart rate, first-dose monitoring is recommended in patients with certain pre-existing cardiac conditions.8

It is not known if ponesimod is safe and effective in children.

On 19 May 2021, the European Commission approved ponesimod for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.8,9

A member of the Janssen Pharmaceutical Companies of Johnson & Johnson, Actelion Pharmaceuticals Ltd is party to a revenue sharing agreement with Idorsia Pharmaceuticals Ltd, which provides for certain payments to Idorsia related to the sales of ponesimod.

About the OPTIMUM trial
The Phase 3 OPTIMUM (NCT02425644) trial – a large pivotal trial and the first to compare an oral disease-modifying therapy (DMT) vs. another oral DMT – was a multicentre, randomised, double-blind, parallel-group, active-controlled superiority study. The trial was designed to evaluate the efficacy and safety of once daily oral ponesimod 20mg vs. once per day teriflunomide 14mg, an approved and widely-used first-line oral treatment, in adult patients with RMS. In total, 1,133 adult patients were randomised at 162 sites in 28 countries.10

The primary endpoint of the 108-week study was the ARR (ponesimod showed a statistically significant rate reduction of 30.5 percent. The ARR for ponesimod 20mg was 0.202 vs. 0.290 for teriflunomide 14mg [p=0.0003]). Secondary endpoints included CUAL per year on magnetic resonance imaging (MRI) to week 108 (ponesimod significantly reduced the number of new inflammatory lesions on brain MRI by 56 percent [p<0.0001] at week 108 when compared to teriflunomide) and time to 12- and 24-week confirmed disability accumulation to end of study (ponesimod-treated patients also showed a numerical benefit in delaying disability progression compared to teriflunomide-treated patients, and had small improvements in the risk of new 3- and 6-month disability [17 percent and 16 percent lower risk, respectively, compared to teriflunomide], although the between-group difference was not statistically significant in either instance).10

The safety profile of ponesimod is consistent with the known safety profile of other S1P receptor modulators, although a head-to-head comparison, other than with teriflunomide, is not available. Overall, the number of treatment-emergent adverse events reported was similar between the ponesimod and teriflunomide treated groups, and the majority were mild/moderate and did not warrant treatment discontinuation. The most frequently reported adverse events in the ponesimod 20mg group vs. the teriflunomide 14mg group were Alanine Aminotransferase (ALT) enzyme elevations (19.5 percent vs. 9.4 percent), nasopharyngitis (19.3 percent vs. 16.8 percent), headache (11.5 percent vs. 12.7 percent), upper respiratory tract infection (10.6 percent vs. 10.4 percent) and alopecia (3.2 percent vs. 12.7 percent).10

Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com/emea. Follow us at www.twitter.com/janssenEMEA for our latest news.

Janssen-Cilag International NV, the marketing authorisation holder for PONVORY™ (ponesimod) in the EU, Janssen Global Services, LLC, and Janssen Cilag GmBH are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding ponesimod. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, Actelion Pharmaceuticals Ltd, Janssen Pharmaceutica NV and/or any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

###

References

  1. DiBernardo A, Turkoz I et al. Ponesimod demonstrated increased clinical benefit over teriflunomide in early disease subgroup compared with overall population. E-poster at the Congress of the European Committee for Treatment Research in Multiple Sclerosis (ECTRIMS) 13-15 October 2021.
  2. DiBernardo A, Turkoz I et al. Ponesimod demonstrated increased clinical benefit over teriflunomide in early disease subgroup compared with overall population. Abstract at the Congress of the European Committee for Treatment Research in Multiple Sclerosis (ECTRIMS) 13-15 October 2021.
  3. National Multiple Sclerosis Society. Definition of MS. Available at: https://www.nationalmssociety.org/What-is-MS/Definition-of-MS. Last accessed: October 2021.
  4. National Multiple Sclerosis Society. Symptoms and Diagnosis. Available at: https://www.nationalmssociety.org/Symptoms-Diagnosis. Last accessed: October 2021.
  5. Giovannoni G, Butzkueven H, Dhib-Jalbut S, et al. Brain health: time matters in multiple sclerosis. Mult Scler Relat Disord. 2016;9(1):5-48.
  6. National Multiple Sclerosis Society. Cognitive Changes. Available at: https://www.nationalmssociety.org/Symptoms-Diagnosis/MSSymptoms/Cognitive-Changes Last accessed: October 2021.
  7. D'Ambrosio D, Freedman MS, Prinz J. Ponesimod, a selective S1P1 receptor modulator: a potential treatment for multiple sclerosis and other immune-mediated diseases. Ther Adv Chronic Dis. 2016;7(1):18-33. doi:10.1177/2040622315617354.
  8. Ponvory summary of product characteristics, June 2021. Available at: https://www.ema.europa.eu/en/documents/product-information/ponvory-epar-product-information_en.pdf Last accessed: October 2021.
  9. Johnson & Johnson. European Commission approves PONVORYTM (ponesimod), a Once Daily, Oral Therapy for the Treatment of Adults with Relapsing Forms of Multiple Sclerosis with Active Disease Defined by Clinical or Imaging Features. Available at:https://www.janssen.com/emea/sites/www_janssen_com_emea/files/european_commission_approves_ponvorytm_ponesimod_a_once_daily_oral_therapy_for_the_treatment_of_adults_with_relapsing_forms_of_multiple_sclerosis_with_active_disease_defined_by_clinical_or_imaging_features.pdf. Last accessed: October 2021.
  10. Kappos L, Fox RJ, Burcklen M, et al. Ponesimod compared with teriflunomide in patients with relapsing multiple sclerosis in the active-comparator phase 3 OPTIMUM study: a Randomized clinical trial. JAMA Neurol. 2021.

CP-266001

Date prepared: October 2021

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media Enquiries:
Alexandra Nisipeanu
Mobile: +40-74-438-3413
Email: adridean@its.jnj.com

Investor Relations:
Jennifer McIntyre
Office: +1-732-524-3922

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

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

Latest releases from Business Wire

Silicon Valley Veterans Launch pulsESG™—an Integrated SaaS Platform for Enterprise ESG Analysis with $8.5M in Seed Funding from Impact-Driven Investors20.10.2021 16:00:00 EEST | Press release

pulsESG™ today announced the launch of its enterprise environmental, social, and governance (ESG) software as a service (SaaS) platform backed by $8.5 million in seed funding from leading impact-driven investors and led by two Silicon Valley enterprise software veterans. The platform distinguishes itself in the marketplace through features such as model-driven architecture and full integration with both internal sources of data and external investor-facing systems, empowering companies to track and derive insights for ESG compliance and improvement based on stakeholder requirements. The company emerged from stealth mode today and the product is expected to be made generally available in Q1 2022. Led by tech veterans and co-founders Murat Sönmez and Inderjeet Singh, the pulsESG™ platform is designed to take a different approach to ESG analysis than what currently exists in the marketplace by providing comprehensive, auditable, and accurate deep analytics that can be integrated with both

Interaxon Inc. (Muse®) Launches the Latest in Non-Pharmaceutical Sleep Support: EEG-Powered ‘Digital Sleeping Pills’ That Provide Immediate & Intelligent Support for Falling Asleep & Nighttime Interruptions20.10.2021 16:00:00 EEST | Press release

Interaxon Inc. (Muse®), a leading consumer neurotechnology and meditation company, today announced the launch of the second generation of its popular EEG meditation & sleep headband, Muse S. This updated plush brain-sensing headband uses real-time biofeedback to help you learn the art of mediation as well as help you fall asleep, stay asleep and now go back to sleep if you awaken during the night. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211020005215/en/ Muse today announced the launch of the second generation of its popular EEG meditation & sleep headband, Muse S. This updated plush brain-sensing headband uses real-time biofeedback to help you learn the art of mediation as well as help you fall asleep, stay asleep and now go back to sleep if you awaken during the night. (Photo: Business Wire) Alongside the launch of the updated Muse S headband, Interaxon is launching an intelligent new kind of EEG-powered sleep experi

ExOne Showcases Ability to 3D Print Virtually Any Powder Material in New Corporate Video, “Let’s Make it Right”20.10.2021 15:30:00 EEST | Press release

The ExOne Company (Nasdaq: XONE), the global leader in industrial sand and metal 3D printers using binder jetting technology, today announced that it is open to developing virtually any powder material in partnership with manufacturers for their specific application. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211020005203/en/ The ExOne Company has released a new corporate video, "Let's Make it Right," showcasing the ability of its sustainable binder jetting technology to 3D print virtually any type of powder. ExOne has already qualified more than 20 metals, ceramics and composites for 3D printing, but is now developing materials such as pulverized concrete and other waste products with customers. (Photo: Business Wire) The material flexibility and sustainability of ExOne’s patented binder jet 3D printing technology is showcased in a new corporate video unveiled today, “Let’s Make it Right.” The video is a celebration of

Workiva Announces 2021 Partner of the Year Award Winners20.10.2021 15:00:00 EEST | Press release

Workiva Inc. (NYSE:WK), the company that simplifies complex work, announced the winners of the 2021 Workiva Partner of the Year Awards. The awards recognize partners that have leveraged their significant industry and solution-specific experience to help customers expand their use of the Workiva platform to drive transparency in reporting and compliance. Award recipients were recognized during the Company’s virtual Global Partner Summit, held October 18 & 19. “Our partners are instrumental in deploying the Workiva platform as a critical component in digital transformations across global enterprises,” said Corey Wells, vice president of partnerships and alliances at Workiva. “It’s an honor to recognize this year’s winners for helping drive the innovation and collaboration that has made a lasting impact on our customers' business.” 2021 Partner of the Year Award Winners Global Partner of the Year - Deloitte Global Technology Partner of the Year - FloQast North American Advisory Partner of

BentallGreenOak Achieves New High Mark for Exceptional Performance in the 2021 Global Real Estate Sustainability Benchmark (GRESB), Marking 11 Consecutive Years of Excellence and Industry Leadership in ESG20.10.2021 15:00:00 EEST | Press release

BentallGreenOak (BGO) announced today that, in a consecutive run of industry leadership now marking 11 years, its global real estate investment platform has achieved a new high mark for exceptional performance in the annual Global Real Estate Sustainability Benchmark (GRESB). Four of BGO’s flagship investment strategies, already amongst the best performing funds in their global categories, achieved five star ratings and higher scores in 2021, reinforcing a firm-wide commitment to enhanced, year-over-year performance in ESG across its platform. For the first time in BGO’s 11 years of GRESB participation, all BGO funds participating in the Development module — which measures an entity’s efforts to address ESG issues during a building’s design, construction and renovation phases — ranked first in their peer group, achieving Sector Leader status. Highlights from BentallGreenOak’s 2021 GRESB scores: All BGO Funds scored 100% on the Management component of GRESB, demonstrating leadership in

Slate Asset Management Expands European Platform with NOK 1 Billion Essential Real Estate Portfolio Acquisition in Norway20.10.2021 14:23:00 EEST | Press release

Slate Asset Management ("Slate”), a global alternative investment platform focused on real estate, announced today the acquisition of a portfolio of 25 essential real estate assets in Norway for approximately NOK 1 billion. The acquisition – Slate’s first in the Nordics – further scales the firm’s European platform and significantly increases Slate’s exposure to high-quality essential real estate assets in broader Europe. The portfolio comprises approximately 50,000 square meters geographically dispersed across Norway, with the majority concentrated in and around Norway’s five largest cities. The entirety of the portfolio’s income is generated by essential goods and service providers, including 24 grocery stores let to class-A tenants and one government-tenanted medical facility. The portfolio’s three major operators are leading Norwegian grocery groups Coop Norge, Reitan Group and NorgesGruppen, which hold around 96% of the total grocery market share in Norway. “We are actively increa

Israeli Food Manufacturer Tnuva Selects DXC Technology to Transform Supply Chain20.10.2021 14:00:00 EEST | Press release

DXC Technology (NYSE: DXC) today announced that it has been awarded one of Israel’s largest ever commercial IT implementation contracts, worth US$40 million, by Tnuva, Israel’s leading producer of dairy and food products. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211020005292/en/ Tnuva’s dairy production line (credit: Tnuva) Under the terms of the five-year agreement, DXC will modernize Tnuva’s IT estate by implementing a new digital supply chain system, which will help the food producer to accelerate operations and provide high quality food to millions of consumers across Israel. DXC will implement a single Enterprise Resource Planning (ERP) solution, based on SAP’s innovative ERP platform SAP S4/HANA ® , to consolidate and modernize approximately 240 of Tnuva’s legacy systems across business applications and dairy management. The system will enable Tnuva to shorten the time to market for new products and optimize its

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom