Boehringer Ingelheim achieves major milestone in chronic kidney disease: aldosterone synthase inhibitor on top of empagliflozin delivers promising results in Phase II trial
Boehringer Ingelheim today announced promising 14-week Phase II data for BI 690517, a novel selective aldosterone synthase inhibitor (ASi). The results showed a significant reduction of albuminuria, a marker of kidney damage,2 by up to 39.5% when BI 690517 was given on top of empagliflozin, a sodium glucose cotransporter (SGLT2) inhibitor, vs. placebo.1 This is the first clinical trial testing this novel treatment class on top of standard of care including empagliflozin in people with chronic kidney disease (CKD),1 which affects more than 850 million people worldwide.3 The findings were presented as a high-impact clinical trial at the American Society of Nephrology (ASN)’s Kidney Week 2023.1
BI 690517 has a novel mode of action that effectively and sustainably inhibits aldosterone synthase, an enzyme that controls the final rate-limiting steps in aldosterone synthesis.1,4 Excessive aldosterone levels cause organ damage and promote cardio-renal-metabolic conditions such as hypertension, chronic kidney disease or heart failure.5
“This unique trial testing a selective aldosterone synthase inhibitor on top of standard of care including SGLT2 inhibition, showed positive and clinically relevant efficacy. Using BI 690517 along with SGLT2 inhibition may offer the potential for additive kidney benefits while possibly mitigating hyperkalemia risk,” said Dr Katherine Tuttle, Principal Study Investigator and Professor of Medicine in the Nephrology Division and Kidney Research Institute at the University of Washington, U.S. “Additional CKD treatments are urgently needed to reduce residual risks of disease progression and serious complications.”
While aldosterone synthase inhibition can lead to moderate elevation of serum potassium,6 this study suggests there is potential that empaglifozin’s mechanism of action can mitigate the risk of hyperkalemia when given as a background therapy.7,8 This effect is of high clinical importance since severe hyperkalemia may lead to changes in medical therapy or hospitalization.9 As a novel drug class, BI 690517, on top of empagliflozin, may address this critical unmet medical need.1
A key secondary endpoint in the Phase II trial was a clinically meaningful reduction in UACR (≥30%) which was achieved by up to 70% of patients treated with BI 690517 on top of empagliflozin.1 Based on analyses assessing albuminuria change as a predictive indicator, these changes may translate into risk reductions for clinical kidney disease events by at least 30%.1
“These encouraging Phase II data not only demonstrate our commitment to developing innovative and transformational treatments for people living with cardio-renal-metabolic conditions but also have the potential to decrease the global burden of these interconnected diseases,” said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim. “With over 1 billion people worldwide affected by these conditions, the potential to help reduce the pressure on healthcare systems and patients is immense. We are proud to be leading the way in this field and are excited to move forward with the upcoming Phase III trial to further investigate the potential of this novel compound on top of standard of care including empagliflozin."
In 2024, Oxford Population Health and Boehringer Ingelheim’s new, international Phase III EASi-KIDNEYTM trial will begin recruitment.1 The trial aims to definitively test the efficacy and safety of BI 690517 given on top of standard of care, including empagliflozin.1 EASi-KIDNEYTM will recruit and follow about 11,000 participants with established CKD, at risk of kidney disease progression, using Oxford Population Health’s streamlined model.1
BI 690517 was generally well tolerated without unexpected safety signals.1 Dose-dependent modest increases in serum potassium levels were observed with BI 690517, which were slightly ameliorated in the presence of empagliflozin. Hyperkalemia occurred at a rate typical for a CKD population,1 and most episodes did not require medical treatment or BI 690517 discontinuation.1
Please click on the following link for ‘Notes to editors’ and ‘References’
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Harro Ten Wolde
Global Head of Media Relations
Email : email@example.com
+49 (6132) 77-181352
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Armis Releases Q4 Update to Its Armis Centrix™ Platform28.11.2023 15:00:00 CET | Press release
Armis, the asset intelligence cybersecurity company, today announced the availability of version 23.3 of the Armis Centrix™ platform. New enhanced integrations, utilizing Armis’ AI Asset Intelligence Engine, enhances organizations’ ability to strategically combine comprehensive data and sophisticated intelligence to efficiently drive key security processes and outcomes. Automated ticketing for vulnerability prioritization and remediation and improved management of alerts are some of the developments customers will benefit from. Moreover improvements were added to Armis Centrix™ Connected Medical Device Security solution with focus on biomedical users to help them manage and monitor medical assets more effectively. Enhancements to Armis Centrix™ OT/IoT security solution increases coverage to more use cases and integrates with more OT vendors to increase scale and visibility across different OT networks. “Armis works in lockstep with its customers, developing new features to our platform
Planview Solutions Now Available in AWS Marketplace28.11.2023 15:00:00 CET | Press release
Planview, a global leader in Portfolio and Value Stream Management, today announced that five of the company’s solutions are now available in AWS Marketplace, a digital catalog with thousands of software listings from independent software vendors that make it easy to find, test, buy, and deploy software that runs on Amazon Web Services (AWS). The solutions currently available include Planview AgilePlace, Planview Hub, Planview Portfolios, Planview ProjectPlace, and Planview Viz. “Companies across industries are faced with an accelerating pace of change – from shifting market dynamics to economic uncertainty, evolving customer expectations, and more,” said Louise K. Allen, Chief Product Officer at Planview. “Success in these conditions requires technology that can help an organization gain a clear view into strategic initiatives, shift priorities, adapt to change, and deliver outcomes faster. By making our solutions available in AWS Marketplace, we’re able to bring the power of Planview
The Future of Electrification Conference Returns for its Third Year28.11.2023 15:00:00 CET | Press release
ZAPI GROUP, a global leader in vehicle electrification, announced the 2024 dates of its Future of Electrification virtual conference taking place on February 7-8, 2024. Following the success of the first two years, the conference will bring together industry leaders and experts in industrial and commercial vehicle electrification to discuss the practical steps to achieve an all-electric reality. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231128007385/en/ The Future of Electrification virtual conference will take place on February 7-8, 2024. (Photo: Business Wire) Presented by ZAPI GROUP, an electrification leader since 1975, the conference will provide insights into the latest technology, industry trends, and geopolitical and regulatory factors driving the electrification revolution. With the consumer automotive market-leading electric adoption, the event’s focus will facilitate conversations showcasing the practical pat
Kenvue to Participate in the Morgan Stanley Global Consumer & Retail Conference on December 6, 202328.11.2023 14:00:00 CET | Press release
Kenvue Inc. (NYSE: KVUE) (“Kenvue”), the world’s largest pure-play consumer health company by revenue, today announced the company’s participation in Morgan Stanley’s Global Consumer & Retail Conference, in New York. Chief Executive Officer and Director, Thibaut Mongon, and Chief Financial Officer, Paul Ruh, will participate in a fireside chat on Wednesday, December 6, 2023 at 11:45 a.m. Eastern Time. A live webcast of the session will be available at https://investors.kenvue.com and a replay will be available on the website following the event. About Kenvue Kenvue is the world’s largest pure-play consumer health company by revenue. Built on more than a century of heritage, our iconic brands, including Aveeno®, BAND-AID® Brand Adhesive Bandages, Johnson’s®, Listerine®, Neutrogena® and Tylenol®, are science-backed and recommended by healthcare professionals around the world. At Kenvue, we believe in the extraordinary power of everyday care and our teams work every day to put that power
Bacardi Gifting Celebrates Sustainability Landmark28.11.2023 14:00:00 CET | Press release
Family-owned Bacardi has announced that it is not only cutting single-use plastic from its gift packs, it will also now reduce the number of cardboard gift boxes for some of its iconic brands. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231128855110/en/ The new limited-edition label for Bacardi-owned BOMBAY SAPPHIRE eliminates the need for a gift pack. The striking design was inspired by the gin brand’s 100% sustainably sourced botanicals. (Photo: Business Wire) Four years ago, Bacardi set itself the ambitious goal of removing 100% of the single-use plastic from its gifting range by the end of 2023. Thanks to innovative new designs, the company has successfully removed almost 275 tons of single-use plastic used annually. “We are incredibly proud of what we have achieved to date but we want to go one step further,” said Rodolfo Nervi, Vice President Safety, Quality and Sustainability for Bacardi. “We don’t want to just red