Download (nintedanib) with add-on of

Press Release
Initiation of first multinational study to evaluate
safety of OFEV® (nintedanib) with add-on of
pirfenidone in patients with IPF
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New study explores safety and tolerability of OFEV® with addon of pirfenidone versus OFEV® alone1
First multinational study involving 100 patients to investigate
add-on treatment with two approved drugs for idiopathic
pulmonary fibrosis (IPF)1
OFEV® slows disease progression with approximately 50%
reduction in the decline of lung function across a broad range
of IPF patient types*2,3,4,5,6,7,8
Ingelheim, Germany 14 December 2015 – Boehringer Ingelheim today
announces the initiation of trial 1199.222 (ClinicalTrials.gov Identifier:
NCT02579603), a new 12 week study to assess the safety, tolerability
and pharmacokinetics of add-on treatment with pirfenidone to
background therapy with OFEV® in patients with idiopathic pulmonary
fibrosis (IPF).1 The trial’s primary endpoint is the percentage of patients
with on-treatment gastrointestinal (GI) adverse events from baseline to
week 12.1
Dr Christopher Corsico, Corporate Senior Vice President Medicine and
Chief Medical Officer at Boehringer Ingelheim, commented “The safety
and wellbeing of patients is at the centre of everything we do. We are
initiating this trial to ensure that we provide the scientific community
with important information regarding OFEV® combination therapy. This
trial is part of our continued commitment to tackling the global burden
of progressive fibrotic lung diseases.”
IPF is a rare condition that causes thickening and scarring of the lung
tissue over time, a process known as fibrosis. 9,10 This fibrosis limits the
amount of oxygen that can be delivered to the major organs and also
causes difficulty breathing.10 The median survival of IPF patients
following diagnosis is just 2-3 years11, underlining the importance of
early and accurate diagnosis and the vital role of treatments that can
help to slow disease progression.
“With the publication in July 2015 of the updated international
evidence-based guideline for IPF, we now have conditional
*Including those with preserved lung function (FVC>90%pred), no honeycombing on HRCT and
concomitant emphysema
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Contact:
Boehringer Ingelheim
Corporate Communications
Media + PR
Dr. Kristin Jakobs
55216 Ingelheim/Germany
Phone: +49 6132 – 77 144553
Fax: +49 6132 – 77 6601
Email: [email protected]
More information
www.boehringer-ingelheim.com
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recommendations for the use of two approved treatment options for
patients with IPF; nintedanib and pirfenidone.” said Prof. Carlo
Vancheri of the Regional Centre for Rare Lung Diseases, Catania, Italy.
“However, there has been limited evidence to date to establish the
safety of combining these treatments. This new trial will provide
essential information regarding the safety of adding pirfenidone to core
treatment with nintedanib, and could help guide future therapy
decisions in IPF.”
~ ENDS ~
Additional Information
About trial 1199.222 (ClinicalTrials.gov Identifier: NCT02579603)
A 12 week, open-label, randomised, parallel-group study evaluating
safety, tolerability and pharmacokinetics (PK) of oral OFEV® when taken
in combination with oral pirfenidone, compared to treatment with OFEV®
alone, in patients with idiopathic pulmonary fibrosis (IPF).1
Patient enrolment for trial 1199.222 started on November 2nd 2015. The
study will enrol approximately 100 patients with confirmed IPF from 25
study centres in the USA, Canada, Italy, Germany, France and the
Netherlands.1
The primary endpoint is percentage of patients with on-treatment
gastrointestinal (GI) adverse events (SOC GI disorders) from baseline to
week 12, as the most frequent adverse events for both products are of
gastrointestinal nature.1 On-treatment adverse events (AEs) are defined
as AEs with an onset from the first dose of randomised treatment up to
the last dose of randomised treatment (inclusive).1
As a secondary endpoint, the amount of OFEV® and pirfenidone
circulating in the blood will be measured during the trial in order to
assess if pirfenidone interacts with OFEV® and influences the amount
found in the blood.1
Eligible participants will be randomised to receive OFEV® 150 mg twice
daily or OFEV® 150 mg twice daily combined with pirfenidone (titrated
up to a dose of 801 mg three times daily).1 Randomised treatment will
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last 12 weeks. During the randomised treatment period, dose
reductions and/or temporary interruptions are allowed for both drugs
in case of AEs.1
About OFEV® (nintedanib)
OFEV® is a small molecule tyrosine kinase inhibitor developed by
Boehringer Ingelheim for IPF.12 OFEV®, one capsule twice a day, slows
disease progression by reducing the annual rate of decline in lung
function by 50% in a broad range of IPF patient types. 2,3,4,5,6,7,8 This
includes patients with early disease (FVC >90% pred) 4 limited
radiographic fibrosis (no honeycombing) on high resolution computed
tomography (HRCT)5 and those with emphysema.6 Side effects with
OFEV® can be effectively managed in most patients. 2
OFEV® targets growth factor receptors, which have been shown to be
involved in the mechanisms by which pulmonary fibrosis occurs. Most
importantly OFEV® inhibits platelet-derived growth factor receptor
(PDGFR), fibroblast growth factor receptor (FGFR) and vascular
endothelial growth factor receptor (VEGFR).2,9,13 It is believed that
OFEV® reduces disease progression in IPF and slows the decline in lung
function by blocking the signalling pathways that are involved in
fibrotic processes.2,13,14
About idiopathic pulmonary fibrosis
IPF is a progressive and life threatening lung disease.11 IPF affects as
many as 14–43 people per 100,000 worldwide.15 ,16 IPF is characterised
by progressive scarring of lung tissue and loss of lung function over
time.9,10 Development of scarred tissue is called fibrosis. Over time, as
the tissue thickens and stiffens with scarring, the lungs lose their ability
to take in and transfer oxygen into the bloodstream and vital organs do
not get enough oxygen.10 As a result, individuals with IPF experience
shortness of breath, a non-productive cough and often have difficulty
participating in everyday physical activities. 17 Acute IPF exacerbations
are defined as rapid deteriorations of symptoms within days or weeks.
These events can occur at any point in the course of the disease, even
at first presentation.18 All patients with IPF are at risk of acute IPF
exacerbations.18
For further information regarding IPF please visit the Boehringer
Ingelheim News Centre: http://bit.ly/1gTNkH7
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Press Release
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany,
Boehringer Ingelheim operates globally with 146 affiliates and a total of
more than 47,700 employees. The focus of the family-owned company,
founded in 1885, is researching, developing, manufacturing and
marketing new medications of high therapeutic value for human and
veterinary medicine.
Social responsibility is an important element of the corporate culture at
Boehringer Ingelheim. This includes worldwide involvement in social
projects, such as the initiative “Making more Health” and caring for the
employees. Respect, equal opportunities and reconciling career and
family form the foundation of the mutual cooperation. In everything it
does, the company focuses on environmental protection and
sustainability.
In 2014, Boehringer Ingelheim achieved net sales of about
13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its
net sales.
For more information please visit www.boehringer-ingelheim.com
Intended audiences:
This press release is issued from our Corporate Headquarters in
Ingelheim, Germany and is intended to provide information about our
global business. Please be aware that information relating to the
approval status and labels of approved products may vary from country
to country, and a country-specific press release on this topic may have
been issued in the countries where we do business.
References:
1
Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in
IPF. Available at: https://clinicaltrials.gov/ct2/show/results/NCT02579603.
Accessed December 2, 2015.
2
Richeldi L, du Bois RM, Raghu G, et al; for the INPULSIS Trial Investigators.
Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med.
2014;380(22):2071-2082
3
OFEV® Summary of Product Characteristics. Boehringer Ingelheim
International GmbH. January 2015.
Boehringer Ingelheim Press Release page 4 of 5
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4
Kolb M, Richeldi L, Kimura T, Stowasser S, Hallmann C, du Bois RM. Effect of
baseline FVC on decline in lung function with nintedanib in patients with IPF:
results from the INPULSIS® trials. Poster presented at the 110th American
Thoracic Society Conference; Denver, Colorado, May 15–20, 2015.
5
Raghu G, Wells A, Nicholson AG, et al. Consistent effect of nintedanib on
decline in FVC in patients across subgroups based on HRCT diagnostic criteria:
results from the INPULSIS® trials in IPF. Poster presented at the 110th American
Thoracic Society Conference; Denver, Colorado, May 15–20, 2015.
6
Cottin V, Taniguchi H, Richeldi L, et al. Effect of baseline emphysema on
reduction in FVC decline with nintedanib in the INPULSIS® trials. Abstract
presented at the 18th International Colloquium on Lung and Airway Fibrosis;
Mont Tremblant, Canada, September 20-24, 2014. Available at:
http://iclaf.com/conference/index.php/2014/ICLAF/paper/view/151. Accessed
December 2, 2015.
7
Costabel U., et al. Efficacy of nintedanib in idiopathic pulmonary fibrosis
across pre-specified subgroups in INPULSIS®. AJRCCM. 2015; 15-10031.
8
Keating GM. Nintedanib: A Review of Its Use in Patients with Idiopathic
Pulmonary Fibrosis. Drugs. 2015 Jul;75(10):1131-40. doi: 10.1007/s40265-0150418-6.
9
Selman M, et al. Idiopathic pulmonary fibrosis: prevailing and evolving
hypotheses about its pathogenesis and implications for therapy. Ann Intern
Med. 2001;134:136-51.
10
NHLBI, NIH. What Is Idiopathic Pulmonary Fibrosis? Available at:
http://www.nhlbi.nih.gov/health/health-topics/topics/ipf/. Accessed December
2, 2015.
11
Ley B., et al. Clinical course and prediction of survival in idiopathic
pulmonary fibrosis. AJRCCM. 2011;183:431–40.
12
Richeldi L, et al. Efficacy of a tyrosine kinase inhibitor in idiopathic
pulmonary fibrosis. N Engl J Med. 2011;365:1079-1087
13
Hilberg F, et al. BIBF 1120: triple angiokinase inhibitor with sustained
receptor blockade and good antitumor efficacy. Cancer Res. 2008;68:47744782.
14
Wollin L, et al. Antifibrotic and Anti-inflammatory Activity of the Tyrosine
Kinase Inhibitor Nintedanib in Experimental Models of Lung Fibrosis.
J Pharmacol Exp Ther. 2014;349:209–220.
15
Raghu G, et al. Incidence and prevalence of idiopathic pulmonary fibrosis.
Am J Respir Crit Care Med. 2006;174:810-816.
16
Fernández Pérez E, et al. Incidence, prevalence, and clinical course of
idiopathic pulmonary fibrosis: a population-based study. Chest. 2010;137:12937.
17
Pulmonary Fibrosis Foundation. Symptoms. Available at:
http://www.pulmonaryfibrosis.org/life-with-pf/about-pf. Accessed December
2, 2015.
18
Collard H, et al. Acute Exacerbations of Idiopathic Pulmonary Fibrosis. Am J
Respir Crit Care Med. 2007;176:636–643.
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