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New Phase III Study of Nintedanib in People with Systemic Sclerosis and Lung Fibrosis Launched
Date:12/8/2015

RIDGEFIELD, Conn., Dec. 8, 2015 /PRNewswire/ -- Boehringer Ingelheim announced today that the first person has been enrolled in the SENSCIS™ (Safety and Efficacy of Nintedanib in Systemic SClerosIS) study. The global Phase III trial, which is now open for recruitment, is investigating the efficacy and safety of nintedanib in people with a rare disease called systemic sclerosis (SSc) who also developed interstitial lung disease (SSc-ILD) (NCT02597933). In total, 520 people are expected to be enrolled in clinical trial centers worldwide.

Systemic sclerosis, also known as scleroderma, is a rare disease characterized by the thickening and scarring of connective tissue of multiple organs in the body. The scarring can also affect the lungs and when this occurs the condition is called SSc-ILD. The presence of ILD with systemic sclerosis often indicates a poor prognosis and higher risk of death.

"People affected by systemic sclerosis with interstitial lung disease are often young, between 25 and 55 years old, and are faced with considerable disability related to the systemic nature of scleroderma. They often have significant shortness of breath and cough from lung disease and severe pain and contractures as a consequence of their skin involvement. This occurs during years when they are deeply engaged in building careers and caring for family," said Kristin Highland, M.D. of the Cleveland Clinic Foundation. "There are no approved treatments, and few drugs have been assessed in clinical trials for this disease. The SENSCIS™ trial will help to further inform the medical community about this disease and whether nintedanib could be an effective therapy."

It is estimated that systemic sclerosis with interstitial lung disease affects up to 86,000 people in the U.S. and 200,000 people in Europe, making it an orphan, or rare disease. Worldwide, it is estimated that approximately two million people have systemic sclerosis, and up to 90 percent may develop some degree of interstitial lung disease.

"The community has been waiting for treatment options for people with systemic sclerosis who have developed interstitial lung disease," said Robert Riggs, CEO, Scleroderma Foundation. "The initiation of Phase III research such as the SENSCISTM trial is an important step forward for people living with the disease and their families."

"To help people living with scleroderma, research is key," said Scleroderma Research Foundation Chairman, Dr. Luke Evnin. "The SENSCIS™ trial represents meaningful progress that may address a significant unmet need by providing the community with a potential new treatment option for this devastating disease."

"Nintedanib, which is marketed as OFEV®, is approved for a rare lung disease called idiopathic pulmonary fibrosis, or IPF, and has been shown to slow disease progression as measured by annual rate of decline in lung function. Because SSc-ILD and IPF share similarities in how the underlying lung scarring, or fibrosis, forms in people with the disease, we are evaluating the impact of nintedanib on lung fibrosis associated with systemic sclerosis," said Danny McBryan, M.D., vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. "The SENSCIS™ study is another milestone in our ongoing commitment to furthering science that addresses the unmet needs of people affected by rare diseases and serious respiratory conditions, including fibrotic lung diseases."

About SENSCIS™
SENSCIS™ is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of nintedanib 150 mg twice daily over 52 weeks up to a maximum of 100 weeks in people with SSc-ILD. The primary endpoint is the annual rate of decline in forced vital capacity (FVC), a measure of disease progression. Key secondary endpoints include the absolute change from baseline in the modified Rodnan Skin Score (mRSS), which is an evaluation of people's skin thickness, and the absolute change from baseline in the Saint George´s Respiratory Questionnaire (SGRQ) total score, which measures the health-related quality of life of people with lung diseases to assess the impact of treatment.

About Systemic Sclerosis and Interstitial Lung Disease
Systemic sclerosis (SSc) is a rare and serious disease characterized by thickening and scarring of connective tissue of multiple organs in the body. It is difficult to diagnose because a lot of organ systems are involved and its symptoms are similar to other autoimmune diseases. The disease impacts four times as many women as men, and the onset of the disease typically occurs at a young age – between 25 and 55 years.

Nearly all people with systemic sclerosis have hardening and thickening of patches of skin. The disease also can cause scarring in the lungs, heart, or kidneys, which can become life-threatening. 

When this scarring affects the lungs it is called SSc-ILD and can make it difficult to breathe and perform daily activities. Lung involvement like ILD is the leading cause of death among people with systemic sclerosis.

For more information, please visit clinicaltrials.gov/ct2/show/NCT02597933.

About OFEV® (nintedanib) capsules
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 (NCT00514683) and the Phase III INPULSIS™ trials (INPULSIS™-1 and INPULSIS™-2; NCT01335464 and NCT01335477). 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.

The studies evaluated the effectiveness of OFEV on slowing the decline in lung function which was measured by forced vital capacity (FVC in mL) over one year (annual rate of decline). All three studies demonstrated a consistent, statistically significant effect on slowing lung function decline with OFEV versus placebo.

  • Phase II TOMORROW™ (n=167):  68% relative reduction (-60 vs. -191 ml/year)
  • Phase III INPULSIS™-1 (n=513):  52% relative reduction (-115 vs. -240 ml/year)
  • Phase III INPULSIS™-2 (n=548):  45% relative reduction (-114 vs. -207 ml/year)

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about OFEV (nintedanib)?
OFEV can cause birth defects or death to an unborn baby. Women should not become pregnant while taking OFEV. Women who are able to become pregnant should use birth control during treatment and for at least 3 months after treatment. If you become pregnant while taking OFEV, tell your doctor right away.

What are the possible side effects of OFEV?
OFEV may cause serious side effects, including:

  • Liver problems. Call your doctor right away if you have unexplained symptoms such as 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 function is working during your treatment with OFEV.
  • Diarrhea, nausea, and vomiting. Tell your doctor if you have diarrhea, nausea, or vomiting or if these symptoms do not go away or become worse. Tell your doctor if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements that can cause diarrhea. While you are taking OFEV, your doctor may recommend that you drink fluids or take medicine to treat these side effects.
  • Heart attack. Tell your doctor right away if you have symptoms of a heart problem. These symptoms may include chest pain or pressure, pain in your arms, back, neck or jaw, or shortness of breath.
  • Stroke. Tell your doctor right away if you have symptoms of a stroke. These symptoms 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. Tell your doctor 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 call1-800-FDA-1088.

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, are a smoker, or have any other medical conditions.

Tell your doctor if you are pregnant or plan to become pregnant. You should avoid becoming pregnant while taking OFEV. OFEV can cause harm, birth defects or death to your unborn baby. Use appropriate birth control methods while taking OFEV and for at least 3 months after your last dose. Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if OFEV passes into your breast milk. You and your doctor should decide if you will take OFEV or breastfeed. You should not do both.

Tell your doctor if you currently smoke. 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, and herbal supplements such as St. John's wort. Keep a list of the medicines you take and show it to your doctor and pharmacist when you get a new medicine.

Click here for full Prescribing Information, including Patient Information.

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.

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 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 146 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

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

In 2014, Boehringer Ingelheim achieved net sales of about $16.96 billion dollars (13.3 billion euros). R&D expenditure corresponds to 19.9 percent of its net sales.

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

Contact:
Boehringer Ingelheim
Pharmaceuticals, Inc.
Name: Jennifer Forsyth
Public Relations
Phone: 203-791-5889
Email: jennifer.forsyth@boehringer-ingelheim.com


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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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