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
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

First Patients Treated with the World’s Smallest Heart Pump, the 9Fr Impella ECP28.10.2020 13:03:00 CETPress release

Abiomed (NASDAQ: ABMD) announces the first two patients have been treated with the Impella ECP expandable percutaneous heart pump. Impella ECP is the smallest heart pump in the world. It measures 9 French (Fr) (3 millimeters) in diameter upon insertion and removal from the body. While in the heart, it expands while supporting the heart’s pumping function, providing peak flows greater than 3.5 L/min. This press release features multimedia. View the full release here: Impella ECP is the world’s smallest heart pump. (Graphic: Business Wire) The first Impella ECP patient was treated by Amir Kaki, MD, an interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital in Detroit, part of Ascension Michigan. The patient had severe narrowing of his coronary arteries. Dr. Kaki successfully opened the patient’s arteries by performing several percutaneous interventions with support from Impella ECP

Alira Health and Embleema Announce Partnership to Deploy Next-Generation Real-World Data Solutions for Life Sciences28.10.2020 13:00:00 CETPress release

Alira Health, a leading international healthcare and life sciences advisory firm, and Embleema, the innovative software provider for patient-driven healthcare data platforms, today announced a strategic partnership to develop next-generation real-world data solutions aimed at accelerating clinical innovation and improving patient outcomes. This press release features multimedia. View the full release here: "Our partnership with Embleema is a critical step in the further development of our real-world evidence capabilities, which connects clinical research, hospital care, and the patient experience,” says Gabriele Brambilla, Chief Executive Officer of Alira Health. Romain Finas, VP of Real World Evidence at Alira Health, adds, “We are excited to offer our clients new solutions for real-world data, which will empower them to better evaluate their treatments and deliver new innovations to patients more quickly.” Robert Chu, Chief Ex

Assurant Acquires Mobile Device Trade-In Innovator HYLA Mobile28.10.2020 12:30:00 CETPress release

Assurant (NYSE: AIZ), a leading global provider of lifestyle and housing solutions that support, protect and connect major consumer purchases, today announced it has entered into a definitive agreement to acquire HYLA Mobile, a leading provider of smartphone software, trade-in and upgrade services. The transaction is expected to close by the end of 2020, subject to regulatory and other customary closing approvals. The acquisition will further strengthen Assurant’s trade-in and upgrade programs by doubling device processing volumes while adding device diversity, talent, patented technology and capabilities. Combined, both organizations will service more than 30 trade-in or upgrade programs globally and be better positioned for the upcoming 5G smartphone upgrade cycle, which is anticipated to spur consumer interest in using trade-in programs to finance new device purchases. “Assurant continues to deepen our focus on connected lifestyles, investing in solutions that help our clients bette

Australia’s Global Talent Visa Program Sees Tech CEOs Swap Silicon Valley for Sydney28.10.2020 12:28:00 CETPress release

Australia’s Global Talent Visa Program, also known as the Global Talent Independent Program, is making waves across the Pacific, attracting dynamic, high-profile business leaders to the country’s shores, with many hailing from the US. The program is fine tuned to attract only the world’s premium business talent, and this highly targeted approach has proven to be a great success as clients include top Palo Alto executives and leading Tech CEOs. The program is aimed at highly skilled individuals and high-income earners and was expressly designed to grow Australia’s innovation and tech economies. The seven future-focused target sectors: AgTech, Space and Advanced Manufacturing, FinTech, Energy and Mining Technology, MedTech, Cyber Security, and Quantum Information, Advanced Digital, Data Science and ICT. With no age limit or investment prerequisite, the only requirements for applicants are to be internationally recognized, prominent in their field, and able to provide evidence of outstand

Bavarian Nordic Adopting Veeva CRM and Veeva Vault PromoMats for Digital Launch of New Vaccines28.10.2020 12:03:00 CETPress release

Veeva Systems (NYSE: VEEV) today announced that Bavarian Nordic is adopting multichannel Veeva CRM and Veeva Vault PromoMats for the digital launch of new products in the U.S. and Europe, including Germany, Switzerland, the Nordics, and the Baltics. Specializing in vaccines for infectious diseases, the company needed advanced commercial solutions to support its digital-first strategy. Veeva brings together multichannel engagement and compliant content for the innovative biotechnology company to drive the right interactions with healthcare professionals (HCPs) across the right channels. “Veeva helped us get new digital capabilities and channels up and running fast to meet an aggressive launch timeline and support our global growth plans,” said Robin Kirkby, vice president of commercial operations at Bavarian Nordic. “We now have the commercial foundation in place for digital engagement and to quickly get vaccines to the patients that need them.” Multichannel Veeva CRM enables Bavarian N

Bang & Olufsen Selects CreatorIQ as Global Influencer Marketing Platform of Record28.10.2020 10:00:00 CETPress release

CreatorIQ, the end-to-end enterprise software powering influencer marketing efforts for global enterprises like Unilever, Rakuten, and H&M, today announced it was selected as the platform of record for high-end consumer electronics company Bang & Olufsen (B&O). The Denmark-based company is leveraging CreatorIQ’s sophisticated, data-driven platform to build and optimize its influencer programs, which includes long-term affiliate programs across key global markets. “Influencer marketing is playing an important role in our digital transformation and media diversification, and is integral to reaching new audiences across our key markets in EMEA, LATAM, and North America,” said Alexei Edwards at B&O. “After an extensive search, CreatorIQ was the standout platform for providing the infrastructure for our global efforts - from discovery to recruitment to measurement - while giving us full visibility into the key data points across each stage.” B&O is leveraging CreatorIQ’s advanced data scien