Business Wire

Safety and efficacy results from the INJOURNEYTM trial investigating OFEV® (nintedanib) with add-on pirfenidone provide new data to support nintedanib’s key role in IPF

Jaa

Results from the INJOURNEYTM trial, investigating the use of nintedanib in combination with pirfenidone in treating idiopathic pulmonary fibrosis (IPF), have just been published in the American Journal of Respiratory and Critical Care Medicine. 1 The prognosis of IPF is devastating, with 50% of patients dying within 3 years of diagnosis.2 Nintedanib is one of two antifibrotic drugs which have been shown to slow the progression of the disease in patients with IPF.3

INJOURNEYTM was a 12-week, open-label, randomised trial evaluating the safety, tolerability, and pharmacokinetics of nintedanib with add-on pirfenidone compared with nintedanib alone, in patients with IPF.1 Change in forced vital capacity (FVC), the most established efficacy endpoint in IPF trials, was evaluated as an exploratory endpoint.

Although more slowly, IPF continues to progress in the majority of patients despite effective treatment. Like other chronic diseases, pulmonologists consider combination therapy as an attractive strategy to further improve treatment outcomes. The scientific community has raised the question of whether a combination of both available drugs would be safe to use in IPF patients.2 The INJOURNEYTM trial provides answers to these questions and is part of Boehringer Ingelheim’s commitment to address this need. The data show that the safety and tolerability profile of nintedanib with add-on pirfenidone is consistent with the known profiles of the individual drugs in patients with IPF.1

“Safety always comes first when considering the right medicine for the treatment of an individual IPF patient. The results from INJOURNEYTM help to close a gap on the questions of the safety, tolerability and possible interactions of adding pirfenidone to nintedanib background therapy in the treatment of IPF. Furthermore, the results are reassuring and supportive of future research on combination regimens with nintedanib in IPF,” said Professor Carlo Vancheri, Professor of Respiratory Medicine, University of Catania, Italy and Director of the Regional Referral Centre for Rare Lung Diseases and the Laboratory of Experimental Respiratory Medicine.

Results from INJOURNEY™

The primary endpoint of INJOURNEYTM was the percentage of patients with on-treatment gastrointestinal (GI) adverse events (AE) from baseline to week 12 of randomised treatment.1 Results show that the combination of nintedanib and pirfenidone resulted in a manageable safety and tolerability profile in the majority of patients.1 Diarrhoea, nausea and vomiting were the most frequent adverse events, consistent with the safety profiles of the individual drugs, with a slightly higher incidence in the pirfenidone add-on group.1 No new safety signals were observed in combination treatment, and serious adverse events were uncommon in both treatment groups.

Results also indicate there may be a slower decline in FVC in patients treated with pirfenidone on the backbone of nintedanib compared with nintedanib alone, suggesting a potential benefit of the combination.1 However, further research will be necessary to fully evaluate the efficacy of the combination.

“We are dedicated to our research in idiopathic pulmonary fibrosis, which is a progressive and deadly condition. Nintedanib’s long-term impact on slowing disease progression, combined with its role in reducing the risk of acute IPF exacerbations, make it a logical first choice IPF treatment. These new data provide a rationale for further research into combination regimens with nintedanib as a backbone treatment,” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Respiratory, Boehringer Ingelheim.

Boehringer Ingelheim has a strong commitment to scientific research with the goal of improving the care of people living with serious respiratory diseases. Our vision is to change progressive fibrosing lung diseases, such as IPF, from fatal diseases to chronic, treatable conditions, and our research continues to evolve treatment knowledge to help transform care for patients.

As part of our commitment, Boehringer Ingelheim is currently enrolling patients to participate in two further clinical trials exploring the full extent of the potential benefit of nintedanib in a broader range of progressive fibrosing lung conditions, other than IPF - SENSCISTM and PF-ILD*. The SENSCISTM study (Safety and Efficacy of Nintedanib in Systemic SClerosIS) is the largest trial to date treating patients with systemic sclerosis (also known as scleroderma) who have also developed interstitial lung disease (SSc-ILD).4 The PF-ILD (progressive fibrosing interstitial lung disease) trial builds on the positive real-world clinical experience in IPF to determine whether nintedanib can effectively treat patients suffering from other progressive fibrosing-ILDs.5 It is the first trial in the field of ILDs which groups patients based on commonalities in pathophysiology and clinical behaviour of their disease, rather than the specific diagnoses.

To access the online publication please follow this link

* Nintedanib is currently not approved for use in SSc-ILD or PF-ILD (other than IPF) and its safety and efficacy has not yet been established.

~ ENDS ~

Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/press-release/injourney-results

Intended audiences:

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business.

Contact information

Boehringer Ingelheim
Corporate Communications
Media + PR
Dr. Kristin Jakobs
Phone: +49 6132 – 77 144553
Fax: +49 6132 – 77 6601
Email: press@boehringeringelheim.com

Tietoja julkaisijasta

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

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

düber Technologies Inc. Secures Funding for 15 Distribution Centers with $50 Million Agreement with Vacone Real Estate26.9.2017 23:59Tiedote

düber Technologies Inc., a software-as-a-service (SaaS) provider serving the cannabis industry, today announced it has signed a $50 million funding agreement with Vacone Real Estate for the acquisition, fit out and master lease for 15 cannabis distribution centers in Washington, Oregon, California, Nevada and Arizona. The deal will allow düber to expand operations to include 400,000 square feet of distribution space that will form the basis of the düber unified distribution technology platform. “At düber, we see an unmet market opportunity for cannabis producers, processors and retailers in key parts of the country,” said Glenn Ballman, founder of düber. “This expansion will allow us to serve our distribution and courier partners while continuing to expand our integrated, omnichannel, real-time platform to partners and consumers in key markets in the cannabis industry

Piraeus Bank Comments on Bank of Greece Audit26.9.2017 19:20Tiedote

In response to a query by the Hellenic Capital Markets Committee, Piraeus Bank notifies the investment community that, on 19 September 2017 and following our prior announcement regarding the same matter, we received a draft report for an audit conducted by the Bank of Greece in the course of an Annual Audit Plan. The audit commenced in February 2017, was concluded in July 2017, and focused on a review of the Bank’s procedures for the implementation of the regulatory framework, as well as risk management procedures and special credit issues. Piraeus Bank cooperated fully and constructively with the Bank of Greece during the audit process. Piraeus Bank will respond to the Bank of Greece within a specific timeline and the final report from the Bank of Greece is expected to follow. Piraeus Bank considers that the historic issues covered by the Bank o

Oxera Releases New Analysis on Europe’s Aviation Market, Revealing Increased Competition between Airports26.9.2017 19:13Tiedote

Oxera Consulting LLP has revisited the subject of airport competition in Europe, conducting research and analysis on the implications of recent market trends on the dynamics between airports and airlines in Europe. Oxera found that the European aviation market grew by 25% between 2010 and 2016, with key trends including the continuing rapid expansion of LCCs (low-cost carriers) and non-traditional hubs in the Middle East and Istanbul. These developments have contributed to an intensification of the rivalry between airports, across all channels through which they compete. With many of these trends now being long established, the competitive pressures on airports, of all sizes, across Europe are highly likely to endure and continue to develop, implying that regulators and government stakeholders will need to address this ‘new normal’. Andrew Meaney, Partner and H

RHÖN-KLINIKUM AG Diligently Presses Ahead with Digitalization26.9.2017 18:29Tiedote

RHÖN-KLINIKUM AG is forging ahead with the implementation of its digitalization strategy and is launching a new collaboration with Austrian enterprise search and big data provider Mindbreeze, a subsidiary of the publicly listed Fabasoft AG. The clinic group will use Mindbreeze’s AI-based (artificial intelligence) search engine technology. With this application ─ in the form of a medical cockpit ─ that has been further developed in close cooperation with RHÖN-KLINIKUM AG, the entire medical staff can orient themselves more quickly and their workload is immediately alleviated. “This new approach to medical information will help us to structure the increasing amount of data and then make the information analyzable and evaluable. This is another aspect in which digitalization presents a tangible, concrete benefit,” says Stephan Holzinger, CEO of the group. The medical cockpit is initially being

Before the winter season, Mytyres.co.uk presents: Europe’s most popular summer tyres in 201726.9.2017 18:14Tiedote

In 2017, Europe’s most popular summer tyres were the Continental PremiumContact 6, the Uniroyal Rainsport 3, and the Dunlop SportMaxx RT2. This is the result of a survey conducted by Mytyres.co.uk, the end-user online shop for tyres, car spare parts and accessories from Europe's largest Internet tyre wholesaler Delticom. The survey was conducted throughout July and August in twelve European countries. Nearly 2,600 visitors to the online store cast their votes before the end of the summer tyre season. They were able to choose from five models by leading brands. “Interestingly, the results show that throughout Europe, high-quality premium brand models are the most popular”, comments Thierry Delesalle from Mytyres.co.uk. “These brands rightly enjoy a good reputation, but these days attractive alternatives are also available in the low-cost quality tyre segment. This also applies to

Quadient Launches Alliances and ISV/Technology Partner Tracks of Partner Advantage Program26.9.2017 17:30Tiedote

www.quadient.com : Quadient, formerly GMC Software, the award-winning leader in Customer Communications Management (CCM), announced today the launch of the Alliances Partner and ISV/Technology Partner tracks of its Partner Advantage Program intended to engage, empower and enable all types of Quadient partners. The two tracks complete the four-track program, which began with the announcement in April 2017 of the Delivery Partner track, designed to provide seamless implementation services for Quadient’s customer base. It was followed by the launch of the Business Partner track in May 2017, which offers technology service providers access to new revenue opportunities. Companies approved to become certified Alliances Partners are system integrators/consultants that deliver services, implement and support the Quadient solutions they recommend to their customers. ISV/Technolo

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme