Business Wire

TRITON Phase 3b Study Results Presented at the European Society of Cardiology Congress


Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson, today announced results from the Phase 3b TRITON trial, the first randomised controlled study evaluating the efficacy and safety of initial triple oral combination therapy (UPTRAVI® [selexipag], OPSUMIT® [macitentan] and tadalafil) compared to initial double oral combination therapy (placebo, macitentan and tadalafil) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension (PAH). Study results were featured as an oral presentation as part of the digital European Society of Cardiology Congress held 29 August – 1 September 2020.

In the TRITON trial, both the initial triple oral therapy and initial double oral therapy arms demonstrated reductions in the primary endpoint, pulmonary vascular resistance, of 54 percent and 52 percent respectively, with no statistical difference observed between both groups.1 Improvements were observed in six-minute walk distance,1 N-terminal pro-brain natriuretic peptide (NT-proBNP) and clinical variables at week 26 in patients who were treated with either initial triple oral or initial double oral combination therapy, with no difference between treatment regimens.2

However, initial triple oral therapy was associated with a 41 percent reduction in the risk of first disease progression event compared to initial oral double therapy at an average follow up of 77.6 and 75.8 weeks, respectively.1 Sixteen initial disease progression events were observed in patients taking initial triple oral therapy, and 27 events were observed in patients taking initial double oral therapy (hazard ratio 0.59; 95 percent confidence interval [CI]; 0.32, 1.09).3 Two patients died in the initial triple therapy group (1.7 percent) compared to nine (7.1 percent) in the initial double therapy group up to the end of the main observation period (hazard ratio 0.23; 95 percent CI 0.05, 1.04). These results are not statistically significant and should be interpreted as exploratory considering the primary endpoint was not met.1,3

The nature of reported adverse events (AEs) were consistent with the known safety profiles of the study medications.1,4,5

“While the study’s primary endpoint was not met, we observed a signal of reduced risk of disease progression in the initial triple oral combination therapy group as compared to the initial double oral therapy group,” said Nazzareno Galiè*, Full Professor of Cardiology at the Department of Experimental, Diagnostic and Specialty Medicine (DIMES) of the UNIBO. “This signal requires further evaluation to enhance our knowledge in the PAH field.”

The efficacy and safety of selexipag has been demonstrated in PAH previously in the pivotal GRIPHON trial, which showed that, compared with placebo, selexipag demonstrated a 40 percent risk reduction in disease progression as captured by the primary composite end point of morbidity and mortality.4,6 Consistent results were seen when selexipag was added to double oral therapy (an endothelin receptor antagonist [ERA] plus a phosphodiesterase type-5 inhibitor [PDE-5i]), compared to double oral therapy alone.7

“Data from the TRITON and pivotal GRIPHON studies reinforce the role of selexipag in the escalation of therapy on top of double oral therapy with an ERA and PDE-5i. These studies reaffirm Janssen’s commitment to innovation and the scientific advancement of PAH treatment and care,” said Alessandro Maresta, M.D., Vice President and Head of Medical Affairs at Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson. “We will continue to invest in the science and remain committed to transforming PAH into a long-term, manageable condition so that patients can live a normal life.”


* Prof. Galiè has received research support from Actelion and has served as a paid consultant to the company. Prof. Galiè is not being paid by Actelion for media opportunities.

About the TRITON Study1,2,3 
TRITON (NCT02558231) is a multicentre, double-blind, placebo-controlled, Phase 3b study, that randomised 1:1 newly diagnosed, treatment-naïve, PAH patients to initial triple oral or initial double oral combination therapy. Macitentan and tadalafil were initiated at randomisation, selexipag/placebo at day 15 (uptitrated until week 12). Efficacy and safety were assessed in a blinded manner and all patients were followed until the end of the observation period (until the last patient randomised completed the week 26 visit; median follow-up time approximately 17 months). The primary endpoint was change in PVR at week 26, expressed as ratio of baseline. Secondary endpoints, tested hierarchically, included change in six-minute walk distance and NT-proBNP at week 26, time to disease progression (centrally adjudicated) from randomisation until the end of observation period plus seven days, and absence of worsening WHO functional class at week 26. Safety was reported up to end of observation period. The trial enrolled 247 patients.

About Selexipag 
Selexipag is an oral selective prostacyclin IP receptor agonist approved by the European Medicines Agency (EMA) for the long-term treatment of PAH in adult patients with WHO functional class (FC) II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies. Selexipag, originally discovered and synthesised by Nippon Shinyaku, is the only globally-available oral treatment that works on the prostacyclin pathway with evidence of long-term outcomes.4

The efficacy of selexipag in PAH was established in GRIPHON (Prostacyclin (PGI2) Receptor agonist In Pulmonary arterial HypertensiON), the largest randomised, controlled trial ever conducted in PAH patients. This double-blind, multicentre study aimed to evaluate the long-term efficacy and safety of oral selexipag and included almost 400 patients who were already receiving double combination PAH treatment. The study provided the first randomised, controlled evidence for triple oral combination therapy in PAH. Selexipag was shown to delay disease progression and significantly reduce the risk of hospitalisation compared with placebo, as well as improving exercise capacity.6 Overall, the most common adverse events in the selexipag group were consistent with the known side effects of prostacyclin, including headache, diarrhoea, nausea, and jaw pain.6

Important Safety Information 
For complete prescribing information, please visit:

About Macitentan 
Macitentan is an oral endothelin receptor antagonist (ERA) approved by the European Medicine Agency (EMA) as monotherapy or in combination for the long-term treatment of PAH in adult patients of WHO Functional Class (FC) II to III.5

The efficacy of macitentan in PAH was established in SERAPHIN (Study with an Endothelin Receptor Antagonist in Pulmonary arterial Hypertension to Improve cliNical outcome), a long-term event-driven study in PAH patients with predominantly WHO FC II-III symptoms treated for an average of two years.5 SERAPHIN was the largest and longest clinical study conducted at that time, and the first completed study that demonstrated long-term outcomes with a composite morbidity and mortality primary endpoint.5,8 Compared with placebo, macitentan significantly reduced the risk of the first occurrence of a morbidity or mortality event (the primary endpoint).5 Macitentan also reduced the risk of PAH-related death and hospitalisation, as well as significantly improving WHO FC and health-related quality of life versus placebo.9,10 Overall, the most common adverse events frequently associated with macitentan than placebo were headache, nasopharyngitis and anaemia.11

Important Safety Information
For complete European Union (EU) prescribing information, please visit:

About Pulmonary Arterial Hypertension (PAH) 
PAH is a specific form of pulmonary hypertension (PH) that causes the walls of the pulmonary arteries (blood vessels leading from the right side of the heart to the lungs) to become thick and stiff, narrowing the space for blood to flow, and causing an increased blood pressure to develop within the lungs. PAH is a serious, progressive disease with a variety of aetiologies and has a major impact on patients' functioning as well as their physical, psychological and social wellbeing. There is currently no cure for PH and it is often fatal.12,13,14 However, the last decade has seen significant advances in the understanding of the pathophysiology of PAH, transforming the prognosis for PAH patients from symptomatic improvements in exercise tolerance 10 years ago, to delayed disease progression today.

About Actelion 
In June 2017, Actelion became part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Actelion's medicines have helped to expand and strengthen Janssen's portfolio with leading, differentiated in-market medicines and promising late-stage compounds. Janssen has added Pulmonary Hypertension as a therapeutic area of focus to maintain the leadership position Actelion has built in this important disease area.

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 Follow us at Actelion Pharmaceuticals Ltd is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Follow Actelion on Twitter @actelion_com.

Cautions Concerning Forward-looking Statements 
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding UPTRAVI® (selexipag) and OPSUMIT® (macitentan). 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 Actelion Pharmaceuticals Ltd, 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 December 29, 2019, 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, 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.

# # #


  1. Galié N, et al. Long-term outcomes in newly diagnosed pulmonary arterial hypertension (PAH) patients receiving initial triple oral combination therapy: Insights from the randomised controlled TRITON study. European Society of Cardiology Congress. 31 August – 1 September 2020. Virtual.
  2. Chin K, et al. Efficacy and Safety of Initial Triple Oral Versus Initial Double Oral Combination Therapy in Patients with Newly Diagnosed Pulmonary Arterial Hypertension (PAH): Results of the Randomized Controlled TRITON Study. Am J Respir Crit Care Med 2020;201:A2928.
  3. Galié, N. Long-term outcomes in newly diagnosed pulmonary arterial hypertension (PAH) patients receiving initial triple oral combination therapy: Insights from the randomised controlled TRITON study. Presented at European Society of Cardiology Congress. 29 August – 1 September 2020. Virtual.
  4. UPTRAVI® (selexipag) Summary of Product Characteristics. Janssen-Cilag International NV. July 2019.
  5. OPSUMIT® (macitentan) Summary of Product Characteristics. Janssen-Cilag International NV. April 2020.
  6. Sitbon O, et al. Selexipag for the Treatment of Pulmonary Arterial Hypertension. N Engl J Med2015;373(26):2522–33.
  7. Coghlan J, et al. Targeting the Prostacyclin Pathway with Selexipag in Patients with Pulmonary Arterial Hypertension Receiving Double Combination Therapy: Insights from the Randomized Controlled GRIPHON Study. Am J Cardiovasc Drugs 2018; 18: 37–47.
  8. Said, K. Macitentan in pulmonary arterial hypertension: The SERAPHIN trial. Glob Cardiol Sci Pract 2014; 2:26–30.
  9. Channick RN, et al. Effect of Macitentan on Hospitalizations. Results from the SERAPHIN Trial. JACC Heart Fail 2015; 3:1-8.
  10. Mehta S, et al. Macitentan Improves Health-Related Quality of Life for Patients With Pulmonary Arterial Hypertension. Results From the Randomized Controlled SERAPHIN Trial. Chest 2017; 151:106-18.
  11. Pulido T, et al. Macitentan and Morbidity and Mortality in Pulmonary Arterial Hypertension. N Engl J Med 2013; 369:809-18.
  12. Vachiéry JL, et al. Challenges in the diagnosis and treatment of pulmonary arterial hypertension.Eur Respir Rev2012; 21:313-20.
  13. Galiè N, et al. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension.Eur Heart J2016;37:67-119.
  14. Hoeper MG, et al. The changing landscape of pulmonary arterial hypertension and implications for patient care. Eur Respir Rev 2014; 23:450-7.

August 2020

Contact information

Media contacts:
Sarah Smith
Mobile: +44 7920 082012

David Keown
Mobile: +44 7973 824614

Investor contact:
Jen McIntyre
Office: +1 732-524-3922

About Business Wire

Business Wire
Business Wire

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

Nexeo Plastics Signs Distribution Agreement in Europe with Kingfa20.10.2020 16:06:00 CESTPress release

Nexeo Plastics, a leading global thermoplastics resin distributor, has signed an agreement with Kingfa to distribute their engineering thermoplastic products throughout Europe. Effective immediately, Nexeo Plastics will carry and distribute Kingfa’s locally made compounds. Each product group offers a wide range of color-matching options and innate characteristics to improve manufacturing and end-product functionality. This includes an array of choices in unfilled, talc-filled, reinforced, toughened, flame-retardant and recycled compounds. “We look forward to partnering with Nexeo Plastics to expand our footprint in Europe and reach new customers who are seeking high-quality, customized compounding solutions,” said Dr. D.H. Sun, managing director of Kingfa Europe. Kingfa, a preeminent leader in the research, production and sales of advanced polymer materials, has European facilities in Wiesbaden, Germany, serving the EMEA region. The location includes an advanced technology production p

Brookfield Renewable Ireland Selects PCI’s Enterprise Cloud Platform to Meet its Energy Billing Requirements20.10.2020 16:00:00 CESTPress release

Brookfield Renewable Ireland has selected PCI’s Enterprise Platform for management of its energy billing requirements in the Irish power market. As part of its agreement with Brookfield Renewable Ireland, PCI will deploy its specifically tailored, cloud-based, integrated platform that incorporates the PCI Billing Solution, and a breadth of capabilities including: Management of complex bilateral contracts, such as power purchase agreements (PPA) Contract settlements calculation engine to perform settlement allocation based on specific business rules Interfaces with upstream and downstream systems Comprehensive auditability with all data versions and updates stored for auditing requirements Extensive workflow automation for invoice creation and management Data extraction, reporting and drill-down capabilities Platform extension to support Brookfield Renewable Ireland’s customer portal Chief Commercial Officer at Brookfield Renewable Ireland, Ciaran O'Brien noted, “To support our business

Goldman Sachs Merchant Banking Division Partners With Leading Data Infrastructure Management Team and Commits up to $500 Million to Form Data Center Platform, Global Compute20.10.2020 16:00:00 CESTPress release

The Goldman Sachs Merchant Banking Division (“GS MBD”) today announced that it has partnered with a seasoned management team, led by long-time data center industry executive Scott Peterson, to form Global Compute Infrastructure LP (“Global Compute” or the “Company”), a newly established global data center infrastructure platform. GS MBD has initially committed to fund up to $500 million of equity capital, primarily from its infrastructure fund, West Street Infrastructure Partners III, LP (“WSIP III”), to enable approximately $1.5 billion in near-term investments deployed across North America, Europe, Asia Pacific and Latin America. Global Compute intends to grow through a combination of acquisitions and organic development to serve customers in geographies with strong secular tailwinds and potential for significant data infrastructure growth. Leveraging the experience and track record of the management team, Global Compute will focus on acquiring and developing facilities which can mee

Andersen Global Signs Collaboration Agreement with Belarus’ Largest Law Firm20.10.2020 15:30:00 CESTPress release

Andersen Global expands its platform in Eastern Europe with the addition of collaborating firm REVERA, one of the top tier law firms in Belarus, broadening the organization’s coverage as it bolsters its foothold in the region. Founded in 1998, the Minsk-based firm provides corporate, commercial, litigation, labor, antitrust, real estate and intellectual property law, focusing on tax and private client services. Led by Managing Partner Dmitry Arkhipenko, REVERA’s team of more than 50 lawyers represents a number of multinational companies and often participates in Belarus’ legislative process. Additionally, the firm has been recognized by Chambers Europe, Legal 500, IFLR 100 and Best Lawyers. “For over 20 years, our firm has built a respectable reputation through our commitment to stewardship and independence, and our ability to provide clients with best-in-class solutions,” Dmitry said. “We look forward to working with the member firms and collaborating firms of Andersen Global as we co

The 26 th China Yiwu International Commodities (Standards) Fair to Kick Off This Month With More Activities to Promote Trade20.10.2020 15:21:00 CESTPress release

The 26th China Yiwu International Commodities (Standards) Fair ("Yiwu Fair") will be held at Yiwu International Expo Center on October 21-25, 2020. Founded in 1995 and as one of the three export exhibitions sponsored by China’s Ministry of Commerce, Yiwu Fair is now the largest, most influential, and most effective daily necessities exhibition in China. Yiwu Fair 2020 will be China’s first large-scale foreign trade exhibition presented both online and offline in the wake of the pandemic. It is expected to attract more than 50,000 professional buyers, with 3,400 international standard booths, covering hardware, electromechanical facilities, electronic & electrical appliances, daily necessities, crafts & ornaments, stationery & office goods, toys, sporting & outdoor products, knitwear, and gift packaging. This year, Yiwu Fair will invite around 10 delegations or 1,600 persons from foreign trade organizations and representative offices based in China, and nearly 20 delegations or 1,800 bu

Loomis Sayles Chief Investment Officer Jae Park Set to Retire in 2021; Deputy Chief Investment Officer David Waldman Named Successor20.10.2020 15:05:00 CESTPress release

Loomis, Sayles & Company, an affiliate of Natixis Investment Managers, announced today that Jae Park, executive vice president, member of the board of directors and chief investment officer, will retire on March 31, 2021 after 19 years with the company. David Waldman, executive vice president, member of the board of directors and deputy chief investment officer, will succeed Jae in the position of chief investment officer (CIO) at the time of Jae’s retirement. Jae and David have partnered in their oversight of Loomis Sayles’ investment platforms and infrastructure since David was named Loomis Sayles’ first deputy CIO in 2013. This press release features multimedia. View the full release here: Loomis Sayles Chief Investment Officer Jae Park set to retire in 2021. (Photo: Business Wire) “David is the ideal successor to Jae; they have been longtime partners responsible for overseeing Loomis Sayles’ investment and research teams and

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