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

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Stilla Launches Access Program for Industry’s First Six-Color Digital PCR System28.7.2021 19:26:00 EEST | Press release

Stilla Technologies, the company innovating the next generation of digital PCR solutions for life science research and molecular diagnostics, is pleased to announce the launch of its 6-Color Digital PCR Access Program which enables early access to the industry’s first Digital PCR system featuring six fluorescent channels for providing the highest multiplexing and detection capacity available on the market today. This represents a broad portfolio expansion of the Company’s original three-color naica® system and includes reagents and digital PCR consumables, automated analytical instrumentation, and turnkey visualization software. The commercial launch of the six-color naica® system is scheduled for Fall 2021. “There is undeniable value in detecting and quantifying multiple mutations, viruses and biomarkers from a single sample. The cost versus depth tradeoffs of NGS make it impractical for the routine testing of many samples per day, while multiplex qPCR lacks the precise quantitation a

Q4 Helps Public Companies and Investment Firms Keep Their Teams Aligned and Informed28.7.2021 16:00:00 EEST | Press release

Q4 Inc. announced today it is applying its unique expertise in delivering mission-critical virtual events to help public companies, buy-side and sell-side firms build transparency, trust and excitement across a widely dispersed workforce. With the seismic shift in working models giving employees increasing flexibility to work both in remote or hybrid setups, maintaining a strong internal communications platform to globally distributed teams is vital for companies across all industries. Simultaneously, the commitment to providing a sustainable work environment and strong corporate culture continues to intensify as companies seek to implement successful ESG policies and programs. Q4’s new Corporate Town Hall subscriptions combine technology and a premium end-to-end service model to help its capital markets clients communicate strategy and best practices, provide quarterly business reviews, host sales kick-offs, and ultimately foster the inclusive culture they have worked so hard to devel

ZS Elects Pratap Khedkar to CEO28.7.2021 16:00:00 EEST | Press release

Global professional services firm ZS today announced that Pratap Khedkar, head of the firm’s global biopharmaceuticals and healthcare ecosystem practices, has been elected to CEO by the firm’s leaders. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210728005232/en/ Pratap Khedkar, CEO, ZS (Photo: Business Wire) Khedkar is the third CEO in ZS’s nearly 40-year history. He was elected by his peers, a structure ZS’s founders Andris A. Zoltners and Prabhakant Sinha established to ensure cultural continuity and to elevate leaders who embody the company’s dedication to strategy, innovation and client collaboration. He succeeds Chris Wright, who served the firm’s maximum term and will be affiliated with ZS for the next five years as part of its principal emeritus program, focusing on the projects that he’s most passionate about. Khedkar has held various leadership roles during his 21 years with ZS. Khedkar has led the firm’s global

Dixa, the Next-Gen CX Platform, Raises $105M Series C to Transform Customer Service Worldwide28.7.2021 15:30:00 EEST | Press release

Founded as a customer service solution that evolved into a customer engagement platform, European company Dixa today announced a Series C funding round totaling $105M. The company is leading the change from customer service to value creation with a multiexperience approach, challenging the status quo and delivering value-driven experiences that generate results for businesses. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210728005430/en/ Dixa Founding Team (Photo: Business Wire) The Series C round is led by General Atlantic, a leading global growth equity investor with a history of backing and scaling companies that transformed their industries, with participation from existing investors Notion Capital Project A and Seed Capital. Dixa will leverage the new funds to invest in product development, including potential new acquisitions (following Dixa’s acquisition of Melbourne-based Elevio in January 2021), and plans to quadr

V.E, Part of Moody’s ESG Solutions, Provides Second Party Opinion on the Kingdom of Spain’s Sovereign Green Bond Framework28.7.2021 15:30:00 EEST | Press release

Moody’s ESG Solutions Group announced today that V.E has provided a Second Party Opinion (SPO) on the Kingdom of Spain’s Sovereign Green Bond Framework. The Framework is aligned with the four core components of the Green Bond Principles 2021 and follows best market practices identified by V.E. Net proceeds of the bonds will exclusively be used to finance or refinance projects tied to the country’s environmental objectives, including renewable energy, biodiversity protection, and climate change adaptation. “The bonds issued under Spain’s Framework will provide an ‘advanced’ contribution to sustainability, the highest score on our four-point scale,” said Patrick Mispagel, MD – Sustainable Finance at Moody’s ESG Solutions. “Our assessment reflects that in many cases Spain’s Framework followed the detailed technical eligibility criteria of the EU Taxonomy Climate Delegated Act. We expect to see additional sovereign issuances as nations increasingly seek to raise capital to support climate

U.S. Food and Drug Administration Grants Breakthrough Therapy Designation to Takeda’s Investigational Compound, TAK-994, an Oral Orexin Agonist in Clinical Development for Narcolepsy Type 1 (NT1)28.7.2021 15:15:00 EEST | Press release

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAK-994,1 its Phase 2 investigational oral orexin agonist, which is designed to selectively target orexin 2 receptors. TAK-994 is currently being studied for the treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy type 1 (NT1),2 a chronic neurological disorder that alters the sleep-wake cycle.3 EDS is a hallmark symptom of NT1 and is characterized by a person’s inability to stay awake and alert throughout the day, and falling asleep unintentionally or at inappropriate times on a daily basis.3,4 The FDA’s Breakthrough Therapy Designation process is designed to expedite the development and review of a drug that is intended to treat a serious condition, for which preliminary clinical evidence exists indicating it may demonstrate a substantial improvement over available therapies on at

BlueConic is the First Customer Data Platform to Offer a Data Clean Room Solution28.7.2021 15:02:00 EEST | Press release

Driven by the death of the third-party cookie and its debilitating impact on the digital advertising industry, data clean rooms are growing in popularity among brands and publishers alike. To meet this demand, BlueConic is proud to announce its own comprehensive data clean room solution, making it the first customer data platform (CDP) to do so. The move will enable its customer base of over 300 companies worldwide to facilitate second-party data sharing in a privacy-safe environment. The solution provides brands and publishers with a privacy-compliant way to combat the effects of Apple and Google’s decisions to deprecate the use of third-party cookies in their respective web browsers, Safari and Chrome. Without such a solution, marketers will lose the ability to measure the impact of digital advertising spend once and for all. Industry analysts agree that BlueConic is uniquely poised to offer such a solution. Unlike other data clean rooms on the market, BlueConic’s solution will: Insu

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