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Eli Lilly and : Boehringer Ingelheim and Eli Lilly - Full results from EMPERIAL exercise ability trials presented

06/22/2020 | 06:18am

RIDGEFIELD - Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced full results from the EMPERIAL-Reduced and EMPERIAL-Preserved trials related to exercise ability and symptom improvement with Jardiance (empagliflozin) in adults with chronic heart failure with reduced and preserved ejection fraction, respectively.

The results were presented through the European Society of Cardiology's HFA Discoveries program.

'The EMPERIAL trials, which assessed exercise ability, are one piece of our clinical program evaluating the potential of Jardiance in treating heart failure, a condition affecting 60 million people worldwide,' said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. 'At the center of our heart failure program are the ongoing EMPEROR trials, which are investigating outcomes including cardiovascular death, hospitalization for heart failure and quality of life. We look forward to sharing results from the EMPEROR-Reduced trial this year for people with heart failure and reduced ejection fraction.'

As previously reported, the EMPERIAL trials showed no significant difference in change from baseline to week 12 in exercise ability with Jardiance versus placebo, as measured by the six-minute walk test, which was the primary endpoint of the studies. In EMPERIAL-Reduced, the median six-minute walk test increased by 13.5 meters with Jardiance compared with 18.0 meters with placebo. In EMPERIAL-Preserved the increase was 10.0 meters with Jardiance versus 5.0 meters with placebo.

Exploratory analyses of EMPERIAL-Reduced suggest Jardiance was associated with improvements in quality of life. Researchers employed the Kansas City Cardiomyopathy Questionnaire (KCCQ), a widely used patient-reported measure of quality of life for heart failure. Mean improvement in total symptom score (TSS) of the KCCQ from baseline to week 12 was 4.55 points higher for Jardiance compared with placebo. Additionally, a greater proportion of those taking Jardiance had improvements compared with placebo in KCCQ-TSS of at least 5 and at least 8 points - two pre-specified thresholds that were identified to measure clinically meaningful response to treatment. Similar exploratory analyses of EMPERIAL-Preserved did not indicate improvements with Jardiance versus placebo in these same measures for adults with heart failure with preserved ejection fraction.

The EMPERIAL trials included people with and without diabetes. The safety profile in those with diabetes was similar to the known safety profile of Jardiance for adults with type 2 diabetes. In those without diabetes, no new safety events were identified, and the frequency of hypoglycemic events with Jardiance in this population was similar to that of placebo. Overall, in both trials, there was no notable difference between Jardiance and placebo in the frequency of adverse events, including those leading to discontinuation of study medication, and no new safety concerns were identified.

Other heart failure guideline-recommended therapies have shown divergent results between studies examining clinical outcomes and symptom improvement, with some showing improvements in outcomes such as mortality, but neutral or inconsistent results in exercise ability and patient-reported outcomes.

'Cardio-renal-metabolic conditions, a group of disorders affecting the heart, kidneys and endocrine systems, are becoming increasingly common,' said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. 'Our EMPOWER clinical trial program, which is exploring the impact of Jardiance across the spectrum of cardio-renal-metabolic conditions, is one of the broadest and most comprehensive of any SGLT2 inhibitor. Through our research we aim to contribute new knowledge that can help improve outcomes for the millions of people affected by these conditions.'

About EMPERIAL

EMPERIAL consisted of two Phase III randomized, double-blind trials in adults with or without diabetes. The trials evaluated the effect of 12 weeks' treatment of once-daily Jardiance 10 mg compared with placebo on exercise ability and heart failure symptoms in patients with chronic heart failure with preserved or reduced ejection fraction. The primary endpoint was measured by the six-minute walk test, a common measure of exercise ability.

EMPERIAL-Preserved [NCT03448406]: investigated Jardiance in patients with chronic heart failure with preserved ejection fraction (HFpEF). The study looked at a functional endpoint how far patients can walk in six minutes and at heart failure symptoms.

Primary endpoint: Change from baseline to week 12 in exercise ability as measured by the distance walked in six minutes

Number of patients enrolled: 315

Completed: October 9, 2019

EMPERIAL-Reduced [NCT03448419]: investigated Jardiance in patients with chronic heart failure with reduced ejection fraction (HFrEF). The study looked at a functional endpoint - how far patients can walk in six minutes - and at heart failure symptoms.

Primary endpoint: Change from baseline to week 12 in exercise ability as measured by the distance walked in six minutes

Number of patients enrolled: 312

Completed: October 7, 2019

Ejection fraction is a measurement expressed as a percentage of the amount of blood that leaves the heart each time it contracts, related to the total blood volume of the heart chambers. During each heartbeat pumping cycle, the heart contracts and relaxes. When the heart contracts, it ejects blood from the two pumping chambers (ventricles). When the heart relaxes, the ventricles refill with blood.

HFpEF occurs when the heart muscle contracts normally but the ventricle muscles are stiff. They do not relax as they should when the ventricle fills with blood, so less blood can enter the heart compared to a normally functioning heart.

HFrEF occurs when the heart muscle does not contract effectively and less blood is pumped out to the body compared to a normally functioning heart.

Both HFpEF and HFrEF lead to similar symptoms of heart failure, specifically difficulty breathing, swelling and fatigue.

About EMPOWER

The EMPOWER program reinforces the long-term commitment of Boehringer Ingelheim and Eli Lilly and Company to evaluate the potential of Jardiance to improve outcomes for adults living with cardio-renal-metabolic conditions. EMPOWER is one of the largest clinical trial programs for an SGLT2 inhibitor to date with more than 13,000 adults worldwide.

The development program encompasses

EMPEROR-Reduced, in adults with chronic heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization due to heart failure

EMPEROR-Preserved, in adults with chronic heart failure with preserved ejection fraction to reduce the risk of cardiovascular death and hospitalization due to heart failure

EMPULSE, in adults hospitalized for acute heart failure to improve clinical and patient reported outcomes

EMPACT-MI, to improve outcomes and prevent heart failure in adults with and without diabetes who have had an acute myocardial infarction

EMPA-KIDNEY, in adults with established chronic kidney disease to reduce the progression of kidney disease and the occurrence of cardiovascular death

EMPERIAL-Reduced, in adults with chronic heart failure with reduced ejection fraction to improve exercise ability and patient reported outcomes

EMPERIAL-Preserved, in adults with chronic heart failure with preserved ejection fraction to improve exercise ability and patient reported outcomes

EMPA-REG OUTCOME, in adults with type 2 diabetes and established cardiovascular disease to reduce the risk of major adverse cardiovascular events, including cardiovascular death

EMPRISE, assessing comparative efficacy, safety, healthcare resource utilization and costs of care in routine clinical care in adult patients with diabetes

About Heart Failure

Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot supply adequate circulation to meet the body's demands for oxygenated blood or to do so requires increased blood volume leading to fluid accumulation (congestion) in the lungs and peripheral tissues. It is a widespread condition affecting 60 million people worldwide and expected to increase as the population ages. Heart failure is highly prevalent in people with diabetes; however, approximately half of all people with heart failure do not have diabetes.

The Jardiance heart failure program was initiated based on data from the EMPA-REG OUTCOME trial, which assessed the effect of Jardiance added to standard of care compared with placebo added to standard of care. EMPA-REG OUTCOME was the first SGLT2 inhibitor trial to show a relative risk reduction in cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. This population was comprised of more than 45% of adults with a prior myocardial infarction.

About Cardio-Renal-Metabolic Conditions

Cardio-renal-metabolic conditions are a group of interconnected disorders affecting the heart, kidneys and endocrine system. In aggregate, these conditions are the leading cause of deaths worldwide, accounting for up to 20 million deaths annually. Conditions within this group include coronary artery disease, heart failure, chronic kidney disease and type 2 diabetes, among many others.

Emerging science on the link between the cardiorenal and metabolic systems supports taking a multidisciplinary approach toward diagnostic, preventive and therapeutic strategies for people living with these conditions. We remain committed to developing treatments with broad cardio-renal-metabolic effects, which may help improve outcomes for people with serious chronic conditions such as these.

Boehringer Ingelheim and Eli Lilly and Company

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance that centers on compounds representing several of the largest diabetes treatment classes. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributing to the alliance. The alliance leverages the strengths of two of the world's leading pharmaceutical companies to focus on patient needs. By joining forces, the companies demonstrate their commitment, not only to the care of people with diabetes, but also to investigating the potential to address areas of unmet medical need. Clinical trials have been initiated to evaluate the impact of Jardiance on people living with heart failure or chronic kidney disease.

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.

About Lilly Diabetes

Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions-from medicines and technologies to support programs and more.

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jardiance and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that Jardiance will receive additional regulatory approvals.

Contact:

Jennifer Forsyth

Tel: (203) 791-5889

Email: jennifer.forsyth@boehringer-ingelheim.com

(C) 2020 Electronic News Publishing, source ENP Newswire

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