Business Wire

Vifor Pharma to revise DIAMOND study, readout expected in H2 2021

Share

Regulatory News:

Vifor Pharma Group today announced that the phase-IIIb DIAMOND study has been amended with new and clinically relevant endpoints, including a new primary endpoint of efficacy in potassium management in high-risk heart failure patients treated with guideline-recommended doses of renin-angiotensin aldosterone system inhibitor (RAASi). This decision has been made on the recommendation from the independent study Executive Committee and following the significant impact of COVID-19 on recruitment.

Patients with heart failure and chronic kidney disease are among those at the highest risk of severe outcomes of COVID-19 infection. During the pandemic, treatment practices have been adapted to reduce risks of exposure to COVID-19 during hospital visits, disrupting clinical care and impacting the conduct of randomized clinical trials such as the DIAMOND study. This has led to fewer patients enrolled in the trial than anticipated and to a slower incidence of cardio-vascular events.

More than 1,000 patients with heart failure and with hyperkalemia or history of hyperkalemia have already been enrolled in DIAMOND. Following the change of endpoints, study read-out and remaining data collection is expected to be completed in 2021.

Prof. Javed Butler, Principal Investigator for the DIAMOND study, said: “Guidelines give strong recommendation to use RAASi to reduce mortality and morbidity in heart failure patients, but unfortunately patients are often treated with low doses, or not treated at all, because RAASi increase potassium levels, which can cause hyperkalemia. The new primary endpoint allows us to investigate the role of Veltassa® in controlling serum potassium and potentially preventing hyperkalemia in heart failure patients treated with RAASi. This will maximize the scientific utility of the data collected in DIAMOND.”

Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma Group, commented: “We believe that this decision is a responsible approach towards the heart failure patients participating in the trial and towards the need of the medical community to learn from the outcomes of the DIAMOND study. A significant amount of evidence on the use of Veltassa® in combination with RAASi medication has been recorded in DIAMOND. We expect these data to support an effective management of hyperkalemia in patients on RAASi therapy with Veltassa® and look forward to sharing this data during spring 2022 at a major conference.”

Vifor Pharma continues to support several data generation programs with the ongoing phase-IV PLATINUM study and the CARE-HK global study platform to drive evidence-based care using Veltassa® in chronic kidney disease and heart failure patients.

Conference call:

Vifor Pharma will host a conference call today, 24 June 2021 at 10:30 am (CET).

Access to conference call → link

About Vifor Pharma Group

Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

For more information, please visit viforpharma.com.

About DIAMOND

This global, multicenter, double-blind, placebo controlled DIAMOND study was designed to evaluate the potential role of Veltassa® in enabling patients with, or at high risk of, hyperkalemia to remain on RAASi therapy. The previous primary endpoint of the study was the time to first occurrence of cardiovascular death or cardiovascular hospitalization. On recommendation of the independent study Executive Committee and due to COVID-19 impact on recruitment, the primary endpoint has been changed to investigate the role of Veltassa® in controlling serum potassium and potentially prevent hyperkalemia in heart failure patients treated with RAASi. More than 1,000 patients with hyperkalemia or history of hyperkalemia, who are therefore not able to use guideline-recommended doses of RAASi, were enrolled in the study.

About hyperkalemia

Hyperkalemia is a serious condition characterized by elevated levels of potassium in the blood. Patients with chronic kidney disease and heart failure, especially those treated with RAASi, are at particular risk of developing the condition. Studies have shown Veltassa® enables patients to remain on RAASi therapy by effectively managing their chronic hyperkalemia.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media Relations
Nathalie Ponnier
Global Head Corporate Communications
+41 79 957 96 73
media@viforpharma.com

Investor Relations
Julien Vignot
Head of Investor Relations
+41 58 851 66 90
investors@viforpharma.com

About Business Wire

Business Wire
Business Wire



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

Bob Slinn Joins FunPlus Senior Leadership Team as Vice President of Business Development4.8.2021 17:15:00 CEST | Press release

FunPlus, a leading independent mobile game developer and publisher, today announced that Bob Slinn has been appointed as Vice President of Business Development for the company. As a member of the company’s senior leadership team headquartered in Switzerland, Slinn will report to Chief Business Officer Chris Petrovic and be responsible for leading the company’s Western market strategic business development efforts. These efforts will include managing and expanding FunPlus’ growing list of global IP partners and deepening the company’s platform relationships, as well as leading developer relations efforts in support of the company’s ongoing strategic investment and M&A activities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210804005425/en/ Bob Slinn Joins FunPlus Senior Leadership Team as Vice President of Business Development (Photo: Business Wire) “We’re delighted to welcome Bob to the team in a leadership role that is t

Tigo Energy Unveils Energy Intelligence Platform to Simplify Fleet Management4.8.2021 16:00:00 CEST | Press release

Tigo Energy, Inc., the solar industry’s worldwide leader in Flex MLPE (Module Level Power Electronics), today unveiled its Energy Intelligence (EI) Solution, a comprehensive digital platform designed to optimize the installer experience around commissioning, monitoring, and maintaining fleets of solar installations. For solar installers, operations and maintenance represents a significant and ongoing burden due to the lack of visibility to the module-level information. Tigo EI quickly identifies issues that increase truck rolls, undermine energy output, and undercut the economic success of said installations. EI also delivers the tools to decrease operation and maintenance costs, increase system performance and revenue, and improve the user experience for both installers and customers. The platform also simplifies the commissioning process by providing greater system visibility and information to end installers and EPCs. “Fleet management technology is the next key enabler in renewable

Avex Releases 100% Hemp Cloth T-shirt4.8.2021 16:00:00 CEST | Press release

Avex Entertainment Inc. began limited sales from July 30 of the T-shirts from a Japanese fabric brand "majotae" (pronounced "ma-yo-tah-e") on its official website, using hemp*1, the natural, sustainable material that is gaining attention globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210804005064/en/ 100% hemp cloth T-shirt made by majotae (Photo: Business Wire) By maximizing the company's knowhow in creating entertainment contents, Avex shares with the world a new concept in sustainability—hemp cloth, which combines both comfort as clothing, and earth-friendly, ecological aspects. Avex is cultivating a brand new field of business that creates moving experiences beyond the field of entertainment. About majotae Majotae is a brand that utilizes modern technology to resurrect the true texture of the hemp cloth that Japanese people have used since ancient times. The greatest feature of "majotae" is its realization of a

Q4 Launches Suite of ESG Communications Products4.8.2021 15:00:00 CEST | Press release

Q4 Inc. (Q4), a leading capital markets communications platform, announced the first phase of new products that standardize how public companies can deliver information regarding their environmental, social and governance (ESG) efforts. At a time of extensive data collection, heightened investor emphasis and mounting regulatory mandates around ESG disclosure, public companies are challenged with what and how best to communicate their social impact and sustainability programs. Similarly investors are taxed with distilling the vast amount of ESG-related information relevant to their investment criteria. In its fundamental commitment to ESG, both as an organization and on behalf of its clients, Q4 has introduced the first of several new offerings that enable public companies to effectively tell their ESG story in a format that makes it easier for investors to consume. Working in tandem with its leading clients, Q4 has established a set of best practice, industry-focused templates for corp

Enedym, Inc. Announces Two New Appointments To Board of Directors4.8.2021 14:00:00 CEST | Press release

Enedym, Inc. (“Enedym”), the technology company thatdevelops next generation switched reluctance motors (SRMs), electric propulsion, and electrified powertrains, announced today that it has appointed Robert Lee, former Vice President of Engines, Electrified Propulsion, and Advanced Powertrain Engineering at Fiat Chrysler Automobiles (FCA) and Ron Harper, President and CEO of JFE Shoji Power Canada Inc., to its board of directors. "We are so pleased to welcome Bob and Ron as new directors to Enedym’s board," said Ali Emadi, Founder, President, and CEO of Enedym. "They join Enedym at an exciting time as we expand our operations and development capabilities in order to continue to transform the electric motor and electrified powertrain sector. Bob’s deep experience in the global automotive sector will bring valuable experience to our rapidly growing automotive electrification business. Ron’s expertise in manufacturing and supply chain management will be valuable in developing Enedym’s eme

yellow.ai Raises $78.15M to Deliver Total Customer Experience Automation4.8.2021 13:33:00 CEST | Press release

yellow.ai, the world’s leading customer experience (CX) automation platform, trusted by 700+ enterprises globally, today announced it has raised $78.15M in Series C, led by WestBridge Capital along with Sapphire Ventures, and Salesforce Ventures. Lightspeed Venture Partners again participated in this round, which brings total funding raised so far to $102.15M. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210804005587/en/ Raises $78.15M to Deliver Total CX Automation (Graphic: Business Wire) yellow.ai enables enterprises to leverage its proprietary NLP engine and platform to build chatbots and voice bots, in 100+ languages, across 35+ channels that automate functions like Customer Support, Customer Engagement, Conversational Commerce, and Employee Experience. The platform comes pre-integrated with enterprise applications like Salesforce, Shopify, Cisco, Avaya, SharePoint, and 100 more. Since its prior funding round, yellow.

ANYbotics Boosts Autonomous Mobile Robots with Velodyne Lidar Sensors4.8.2021 12:48:00 CEST | Press release

Velodyne Lidar, Inc. (Nasdaq: VLDR, VLDRW) today announced ANYbotics is equipping its autonomous mobile robots with Velodyne’s Puck™ lidar sensors. ANYbotics robots provide industrial operators with an automated robotic inspection solution to support efforts in monitoring and maintaining plants. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210804005237/en/ Equipped with Velodyne Lidar’s Puck™ sensors, ANYbotics’ four-legged robot ANYmal performs inspection and monitoring tasks in challenging industrial terrains such as mining and minerals, oil and gas, chemicals, energy and construction. (Photo: ANYbotics) ANYbotics’ four-legged robot ANYmal performs inspection and monitoring tasks in challenging industrial terrains such as mining and minerals, oil and gas, chemicals, energy and construction. ANYmal’s legs provide unparalleled mobility when moving up and down stairs, climbing over obstacles, steps and gaps, and crawling in

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom