Icahn School of Medicine at Mount Sinai and Boehringer Ingelheim collaborate on first study to evaluate nintedanib in patients with fibrosing ILD following COVID-19 infection

New York, NY and Ridgefield, Conn., November 19, 2020 – The Icahn School of Medicine at Mount Sinai and Boehringer Ingelheim today announced the first patient has enrolled in a new clinical study to investigate the effect of nintedanib in adult patients having acute lung injury following COVID-19 infection.

“A significant percentage of COVID-19 patients with acute lung injury may develop lung fibrosis based on clinical observations,” said Maria Padilla, M.D., primary investigator, director of the Advanced Lung & Interstitial Lung Disease Program at the Icahn School of Medicine at Mount Sinai. “Our team of researchers and our partner Boehringer Ingelheim share a commitment to improving outcomes in this vulnerable patient population.”

The study, called ENDCOV-I (Early Nintedanib Deployment in COVID-19 Interstitial Fibrosis) [NCT04619680], is a randomized, double-blinded, placebo-controlled study conducted at the Icahn School of Medicine to investigate the development and course of pulmonary fibrosis in 120 patients receiving nintedanib or placebo who have acute lung injury secondary to COVID-19 infection, and who required invasive or noninvasive respiratory support.

The primary endpoint of the study is percent change in forced vital capacity (FVC), a measurement of lung function, compared to baseline over six months (180 days). Secondary endpoints include change from baseline FVC at 90 days, death within 90 days and 180 days from enrollment due to respiratory or any cause and qualitative and quantitative change in chest CT fibrosis score graded by blinded chest radiologists.

“Boehringer Ingelheim is committed to fighting COVID-19 and proud to partner with Mount Sinai on this important clinical initiative,” said Craig Conoscenti, M.D., medical expert, Interstitial Lung Disease Medical Leader, Chronic Fibrosing ILD Program, Clinical Development and Medical Affairs, Boehringer Ingelheim. “The insights gained from this collaborative research program will help our understanding of pulmonary fibrosis in the COVID-19 patient population.”

Mount Sinai commitment against COVID-19
Throughout the course of the COVID-19 outbreak in New York, Mount Sinai has been at the forefront of understanding, researching and treating the disease. We have helped large numbers of people recover from the virus, and we have learned and enhanced the knowledge of this infection and manifestations along the way. We have recognized the multi-systemic nature of the disease and the lingering effects that continue to impact the patients. This has led to the establishment of the multidisciplinary Center For Post-COVID Care. We are committed to bringing information as it comes to light and to pursue investigation and scientifically based modalities of treatment and care.

Find out what Mo​unt Sinai researchers, doctors, and service providers are learning — and doing — about the novel coronavirus here.

BI commitment against COVID-19
As a research-driven company, Boehringer Ingelheim is part of the collective effort in fighting COVID-19. Drawing from its areas of scientific expertise, the company has engaged in a number of activities to find medical solutions to this pandemic, working closely with academic researchers, international institutions, and others in the pharma industry.

Boehringer Ingelheim is currently involved in a broad set of initiatives to fight the disease and save patients’ lives, including the research and development of SARS-CoV-2 antibodies that can neutralize the virus, small molecules to inhibit its replication, and therapy development to prevent microcoagulation (blood clots). The company recently began a Phase 2 clinical trial of a novel, targeted therapy to help people with severe respiratory illness from COVID-19.

Boehringer Ingelheim is also an active participant in the global access initiative with the Bill and Melinda Gates Foundation as well as global development initiatives including the COVID-19 Therapeutics Accelerator (CTA) and the CARE Consortium.

About nintedanib
Nintedanib is approved in the U.S. for the treatment of idiopathic pulmonary fibrosis (IPF) and available as Ofev®. In September 2019, nintedanib was approved in the U.S. to slow the rate of decline in pulmonary function in patients with SSc-ILD, and then in March 2020 to treat chronic fibrosing ILDs with a progressive phenotype.

About the Mount Sinai Health System
The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's "Honor Roll" of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in the country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally by U.S. News & World Report.

For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Twitter and YouTube.

About Boehringer Ingelheim
Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.

Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives.

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

What is OFEV?

• OFEV is a prescription medicine used:
  • to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).
  • to treat people with a chronic (long lasting) interstitial lung disease in which lung fibrosis continues to worsen (progress).
  • to slow the rate of decline in lung function in people with systemic sclerosis-associated interstitial lung disease (SSc-ILD) (also known as scleroderma-associated ILD).
• 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?

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 highly effective birth control at the start of treatment, during treatment, and for at least 3 months after your last dose. Talk with your doctor about what birth control method is right for you during this time. Birth control pills may not work as well in women having vomiting, diarrhea, or other problems reducing the drug absorption. If you have any of these problems, talk with your doctor about what highly effective birth control method is right for you. If you become pregnant or think you are 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 about all of your medical conditions, including 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.

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, and 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, feeling tired, or loss of appetite. Your doctor will do blood tests to check how well your liver is working before starting and 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 one 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, 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.

Please see full Prescribing Information, including Patient Information.

CL-OF-100044 10.28.2020

MPR-US-101473