Boehringer Ingelheim Phase III Study Now Enrolling Patients with Progressive Fibrosing Lung Diseases

RIDGEFIELD, Conn., April 19, 2017 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the first patient has been enrolled in the PF-ILD (progressive fibrosing interstitial lung disease) trial. This study investigates the efficacy and safety of nintedanib in a range of progressive fibrosing lung conditions other than idiopathic pulmonary fibrosis (IPF).

There are over 200 conditions that affect the tissue and space around the air sacs of the lungs (interstitium). These conditions are called interstitial lung diseases or ILDs. Based on clinical observations, there is a group of patients with ILD who, independent from the classification of the ILD, exhibit progressive fibrosis. The proposed terminology for describing this group of patients is PF-ILD. In these patients, the disease appears to follow a course similar to IPF with worsening of respiratory symptoms, lung function, quality of life and ability to perform daily activities, as well as early mortality despite treatment.

"This trial enrolls patients who have lung fibrosis of at least 10 percent by chest imaging that is getting worse by symptoms, physiology or imaging, despite treatment," said Kevin Flaherty, M.D., coordinating principal investigator of the PF-ILD trial. "This trial is an innovative way to study a potential treatment for patients with progressive fibrosing lung diseases and is an important step in exploring the way fibrosis of the lungs is treated and whether nintedanib could be an effective therapy."

Nintedanib, which is marketed as Ofev®, is approved for a rare lung disease called IPF, in which it has been shown to slow disease progression as measured by annual rate of decline in lung function. Building on the positive real-world clinical experience in IPF, the Phase III trial is now exploring whether nintedanib can effectively target the scarring in the lungs of patients suffering from other progressive fibrosing ILDs.

"Boehringer Ingelheim is dedicated to advancing the understanding of fibrosing lung diseases where no or limited treatments exist," said Christopher Corsico, M.D., chief medical officer, Boehringer Ingelheim. "Our innovative PF-ILD trial is designed to include patients with fibrosing lung diseases who would not otherwise be eligible to participate in a clinical trial. This demonstrates the commitment of Boehringer Ingelheim to transform fibrosing interstitial lung diseases from fatal diseases to chronic, treatable ones."

About the study 
This double-blind, randomized, placebo-controlled [NCT 02999178] study will evaluate the efficacy and safety of nintedanib 150 mg twice daily over 52 weeks in patients with PF-ILD. The primary endpoint is the annual rate of decline in forced vital capacity (FVC), a measure of disease progression. Other clinical evaluations include the absolute change from baseline in the King's Brief Interstitial Lung Disease Questionnaire (K-BILD), which measures the health-related quality of life of patients with ILDs to assess the impact of treatment. Other main secondary endpoints include time to first ILD exacerbation and overall survival. The study will include patients with PF-ILD with documented lung scarring on imaging (high-resolution computer tomography, HRCT), and whose lung function and respiratory symptoms or chest imaging have worsened despite treatment.

About PF-ILD 
Interstitial lung disease (ILD) encompasses a large group of over 200 lung disorders, but there is no widely accepted single classification. Based on clinical observations, there is a group of patients who, independent of their ILD diagnosis, at some point in time develop a progressive phenotpye. Based on their similar disease characteristics, including decline in lung function and early mortality, it is thought to be appropriate to group these conditions together, regardless of their ILD diagnosis. PF-ILD is the umbrella term for this group of patients.

About OFEV® (nintedanib)  
The U.S. Food and Drug Administration (FDA) approved OFEV for the treatment of idiopathic pulmonary fibrosis (IPF) on October 15, 2014. OFEV is one of the first FDA-approved drug treatments for IPF and the only kinase inhibitor approved to treat this disease.

The approval was based on findings from a robust clinical trial program involving more than 1,200 patients with IPF worldwide, and included the Phase II TOMORROW® trial and the Phase III INPULSIS® trials (INPULSIS®-1 and INPULSIS®-2. All these studies were randomized, double-blind, placebo-controlled trials comparing OFEV 150 mg twice daily to placebo for 52 weeks. Both INPULSIS® trials were identically designed while the TOMORROW study design was similar.

What is OFEV? 
OFEV is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF). It is not known if OFEV is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about OFEV (nintedanib)?

OFEV can cause harm, birth defects or death to an unborn baby.  Women should not become pregnant while taking OFEV.  Women who are able to become pregnant should have a pregnancy test before starting treatment and should use birth control during and for at least 3 months after your last dose. If you become pregnant while taking OFEV, tell your doctor right away. 

What should I tell my doctor before using OFEV? Before you take OFEV, tell your doctor if you have:

• liver problems
• heart problems
• a history of blood clots
• a bleeding problem or a family history of a bleeding problem
• had recent surgery in your stomach (abdominal) area
• any other medical conditions.

Tell your doctor if you:

• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if OFEV passes into your breast milk. You should not breastfeed while taking OFEV.
• are a smoker.  You should stop smoking prior to taking OFEV and avoid smoking during treatment.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements such as St. John's wort.

What are the possible side effects of OFEV?

OFEV may cause serious side effects. 

TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side effects, including:

• Liver problems. Unexplained symptoms may include yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal or feeling tired.  Your doctor will do blood tests regularly to check how well your liver is working during your treatment with OFEV.
• Diarrhea, nausea, and vomiting. Your doctor may recommend that you drink fluids or take medicine to treat these side effects.  Tell your doctor if you have these symptoms, if they do not go away, or get worse and if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements. 
• Heart attack. Symptoms of a heart problem may include chest pain or pressure, pain in your arms, back, neck or jaw, or shortness of breath. 
• Stroke. Symptoms of a stroke may include numbness or weakness on 1 side of your body, trouble talking, headache, or dizziness.
• Bleeding problems.  OFEV may increase your chances of having bleeding problems.  Tell your doctor if you have unusual bleeding, bruising, or wounds that do not heal and/or if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.
• Tear in your stomach or intestinal wall (perforation). OFEV may increase your chances of having a tear in your stomach or intestinal wall.  Tell your doctor if you have pain or swelling in your stomach area.

The most common side effects of OFEV are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.

These are not all the possible side effects of OFEV. For more information, ask your doctor or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here for full Prescribing Information, including Patient Information.

About Boehringer Ingelheim 
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families.  Our employees create and engage in programs that strengthen our communities. Please visit our website to learn more about how we make more health for more people through our Corporate Social Responsibility initiatives.

In 2016, Boehringer Ingelheim achieved net sales of about $17.6 billion (15.9 billion euros). R&D expenditure corresponds to 19.6 percent of its net sales.

For more information please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS. 

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SOURCE Boehringer Ingelheim Pharmaceuticals