CA-VIFOR-PHARMA
18.5.2020 07:02:06 CEST | Business Wire | Press release
Regulatory News:
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200517005052/en/
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and ChemoCentryx, Inc., (NASDAQ: CCXI) today announced topline data from a forty-six (46) patient phase-II dose-ranging trial in the orphan kidney disorder, primary Focal Segmental Glomerulosclerosis (FSGS). The LUMINA-1 trial tested CCX140, an orally-administered selective inhibitor of the chemokine receptor known as CCR2, in primary FSGS subjects. In the study, CCX140 did not demonstrate a meaningful reduction in proteinuria relative to the control group after 12 weeks of blinded treatment.
Stefan Schulze, Chief Executive Officer Vifor Pharma Group comments, “Unfortunately, the results of the phase-II LUMINA-1 trial are not what we have hoped for in the interests of patients suffering from this debilitating disease. These kind of setbacks are part of clinical development activities and do not affect our confidence in our strategy and ability to deliver strong growth from new and existing products in the future. Our overall partnership and collaboration with ChemoCentryx has been highly successful and is unaffected by this development.”
“With the CCR2 inhibitor CCX140 we desired to help people with FSGS,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. “Regrettably the data observed in the dose-ranging phase-II LUMINA-1 trial of CCX140 do not provide a productive way forward in this patient population. While CCX140 won’t move forward in FSGS, an entirely different situation exists with our lead program, the C5aR inhibitor avacopan. With the avacopan program, we remain intensely focused on our NDA submission for patients with ANCA-associated vasculitis mid-year, along with data readouts for the renal disease C3 glomerulopathy (C3G) by the end of the year, the dermal indication HS in Q3, and we are actively exploring the expansion of avacopan’s unique potential in kidney disease.”
LUMINA-1 was a dose-ranging phase-II study enrolling 46 patients with primary FSGS. The primary efficacy measure was a change in proteinuria (measured by urine protein to creatinine ratio, UPCR) in four blinded treatment groups (three active CCX140 doses vs placebo) from baseline to week 12. At week 12, all subjects including those in the placebo group were then treated with the highest dose of CCX140, 15 mg twice daily (BID) for an additional 12 weeks of treatment, after which UPCR changes from week 12 to week 24 were also assessed. In the intent to treat (ITT) analysis of UPCR changes at week 12 relative to baseline, the 15 mg BID CCX140 group exhibited the greatest reduction of UPCR (median reduction from baseline 0.9 g/g or approximately 30%, and approximately 25% reduction from baseline for the geometric mean), but that did not differ significantly from the placebo group (median reduction from baseline 0.45 g/g; or approximately 22%, and approximately 23% reduction from baseline for the geometric mean). Also, after crossover of the blinded portion of the trial to 15 mg BID active dosing, the previous placebo group did not appear to exhibit an additional reduction of UPCR. CCX140 at all doses was well-tolerated, with no serious adverse events (SAE’s) during the blinded trial and a numerically lower rate of treatment-emergent adverse events in the CCX140 treatment groups than in the placebo group. A full analysis of the LUMINA-1 data is underway and expanded results are expected to be announced at a medical meeting later this year.
About LUMINA-1 LUMINA-1 was a multi-center, randomized, double-blind, placebo-controlled dose-ranging study designed to evaluate the safety and efficacy of CCX140 in patients primary FSGS with ≥1 gram/day baseline proteinuria (protein in the urine). The study enrolled a total of 46 patients worldwide, randomizing them to one of four arms (1:1:1:1). Patients received a placebo or CCX140 dosed at 5 mg once-daily, 10 mg twice daily, or 15mg twice daily over 12 weeks. All patients enrolled in the study remained on background therapy of either Angiotensin converting enzyme inhibitors (ACEi) or Angiotensin II receptor blockers (ARBs). After the 12-week randomization period, all patients were eligible for an additional 12 weeks of CCX140 treatment in an open-label extension (OLE) with the highest safe dose of CCX140, which was 15mg twice daily. There was a four week follow up period from week 24-28 where no CCX140 was administered.
About CCX140
CCX140 is an orally-administered inhibitor of the chemokine receptor known as CCR2. CCX140 was previously evaluated in a phase-II placebo-controlled, clinical trial in patients with diabetic nephropathy. CCX140 treatment in these patients resulted in a statistically significant reduction in proteinuria.
About Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma
Vifor Pharma Group is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. Vifor Pharma Group consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, a joint company with Fresenius Medical Care; Relypsa; and OM Pharma. Vifor Pharma Group is listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348). For more information, visit www.viforpharma.com . Vifor Fresenius Medical Care Renal Pharma Ltd., a common company of Vifor Pharma Group and Fresenius Medical Care, develops and commercialises innovative and high quality therapies to improve the life of patients suffering from chronic kidney disease (CKD) worldwide. The company was founded at the end of 2010 and is owned 55% by Vifor Pharma Group and 45% by Fresenius Medical Care. For more information about Vifor Fresenius Medical Care Renal Pharma and its parent companies, please visit www.vfmcrp.com , www.viforpharma.com and www.freseniusmedicalcare.com .
About ChemoCentryx
ChemoCentryx is a biopharmaceutical company developing new medications targeted at inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally-administered therapies. ChemoCentryx is currently focusing on two late stage drug candidates with distinctly-different mechanisms of action for patients with rare and orphan diseases, avacopan (CCX168) and CCX140.
Avacopan is an orally-administered small molecule that is a selective inhibitor of the complement C5a receptor, or C5aR. In the pivotal phase-III ADVOCATE trial, avacopan demonstrated the ability to induce vasculitis remission at 26 weeks and statistical superiority in sustaining vasculitis remission at 52 weeks. The topline safety results revealed an acceptable safety profile in this serious and life-threatening disease with fewer subjects having serious after events in the avacopan group than in the glucocorticoid-containing standard of care. ChemoCentryx is also developing avacopan for the treatment of patients with C3 glomerulopathy (C3G) and hidradenitis suppurativa (HS). The U.S. Food and Drug Administration has granted avacopan orphan-drug designation for ANCA-associated Vasculitis and C3G. ChemoCentryx expects to release avacopan topline data from its ACCOLADE phase-II trial in C3G by the end of 2020 and from its phase-II AURORA trial in HS in the third quarter 2020. The European Commission has granted orphan medicinal product designation for avacopan for the treatment of two forms of ANCA-associated Vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener's granulomatosis), as well as for C3G.
The Company's other late stage drug candidate is CCX140, an inhibitor of the chemokine receptor known as CCR2, which is being evaluated in the phase-II LUMINA-2 trial in patients with focal segmental glomerulosclerosis (FSGS) with the more severe nephrotic levels of proteinuria.
The U.S. Food and Drug Administration has granted CCX140 orphan-drug designation for the treatment of FSGS.
ChemoCentryx's Kidney Health Alliance with Vifor Pharma provides Vifor Pharma with exclusive rights to commercialize avacopan and CCX140 in markets outside of the U.S.
ChemoCentryx also has early stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer.
Vifor Pharma Group is a global specialty pharmaceuticals company. For more information, visit www.viforpharma.com .
A common company of Vifor Pharma Group and Fresenius Medical Care, develops and commercializes innovative and high quality therapies to improve the life of patients suffering from chronic kidney disease (CKD) worldwide. For more information about Vifor Fresenius Medical Care Renal Pharma and its parent companies, please visit www.vfmcrp.com , www.viforpharma.com and www.freseniusmedicalcare.com .
Forward-Looking Statements
ChemoCentryx cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "may," "could," "will," "would," "should," "expect," "plan," "anticipate," "believe," "estimate," "intend," "predict," "seek," "contemplate," "potential," "continue" or "project" or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Company's statements regarding the achievement of anticipated goals and milestones, when full data analysis of LUMINA-1 and topline LUMINA-2 clinical data might become available or announced, whether the avacopan NDA for ANCA vasculitis will be filed mid-year, the timing of topline data from the avacopan Phase II studies in the treatment of HS and C3G and whether the Company's drug candidates will be shown to be effective in ongoing or future clinical trials. The inclusion of forward-looking statements should not be regarded as a representation by ChemoCentryx that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in the ChemoCentryx business and other risks described in the Company's filings with the Securities and Exchange Commission ("SEC"). Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ChemoCentryx undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading "Risk Factors" in ChemoCentryx's periodic reports filed with the SEC, including ChemoCentryx's Annual Report on Form 10-K filed with the SEC on March 10, 2020 and its other reports which are available from the SEC's website (www.sec.gov ) and on ChemoCentryx's website (www.chemocentryx.com ) under the heading "Investors." All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200517005052/en/
About 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
Clinilabs Announces Medical Leadership Appointments5.8.2026 16:05:00 CEST | Press release
Bob Dagher, M.D., Named Chief Medical Officer and Waqar Ahmed Siddiqui, M.D., Named Principal Investigator Clinilabs (“Clinilabs LLC”), a global, full-service contract research organization (CRO) specializing in central nervous system (CNS) drug and device development, today announced the appointments of Bob Dagher, M.D., as Chief Medical Officer and Waqar Ahmed Siddiqui, M.D., as Principal Investigator of the Company’s Eatontown, New Jersey Clinical Research Unit (CRU). Dr. Dagher will provide strategic and medical leadership across the organization, while Dr. Siddiqui will lead the execution of research projects at the Company’s CRU. Together, they will support the design, development, and execution of clinical programs for pharmaceutical, biotechnology, and medical device sponsors advancing innovative therapies for psychiatric, neurological, substance use, and rare CNS disorders. “Clinilabs has earned the trust of sponsors by combining deep scientific expertise, medical leadership,
Interactive Brokers Adds Brazilian Futures through Brazil’s B3 Exchange5.8.2026 16:00:00 CEST | Press release
Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced that eligible clients outside of Brazil can now trade Brazilian futures in addition to equities through the B3 exchange. Interactive Brokers was the first broker to provide international investors with streamlined, low-cost access to B3. Offering Brazilian futures and equities alongside products across more than 170 markets worldwide underscores IBKR’s commitment to broadening global market access and giving clients efficient, cost-effective ways to diversify through a single, unified platform. Access to B3 provides exposure to one of Latin America’s most active and liquid markets, providing long-term growth potential across multiple sectors and another way for investors to pursue emerging market opportunities. "Global investors deserve seamless, low-cost access to the world's most compelling markets, including emerging economies shaping tomorrow's financial landscape," said Milan Galik, Chief Executive Off
Speech Processing Solutions Launches Philips SpeechLive Legal AI Assistant for Faster, More Accurate Legal Document Creation5.8.2026 15:37:00 CEST | Press release
The new SpeechLive Legal AI Assistant reduces the administrative burden on legal professionals through customizable document drafting powered by speech recognition tuned for legal terminology Speech Processing Solutions, the global leader in AI-assisted professional dictation and documentation solutions sold under the Philips brand, today announced the Philips SpeechLive Legal AI Assistant. The new solution transforms voice recordings, dictation and uploaded sources into structured, ready-to-review legal documents, helping legal professionals work faster while retaining control of the final draft. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260805997413/en/ The new Philips SpeechLive Legal AI Assistant is designed for turning conversations into ready-to-review legal document drafts. SpeechLive Legal significantly reduces the time needed to transform voice input into structured legal documentation, delivering consistent an
Corpay Cross-Border Named the Official FX Partner of Ultimate Sevens5.8.2026 15:31:00 CEST | Press release
Providing access to currency risk management and cross-border payments solutions Corpay, Inc.*, (NYSE: CPAY) a global leader in corporate payments, is pleased to announce that Corpay’s Cross-Border business has entered into an agreement with Ultimate Sevens, a new global rugby sevens championship backed by BIA Sports Group launching in August 2026. Under the agreement, Corpay becomes Ultimate Sevens exclusive and Official Foreign Exchange (FX) Partner, along with being an Ultimate Sevens Playmaker. As the Championships’ exclusive foreign exchange partner, Corpay Cross-Border will provide Ultimate Sevens with comprehensive FX risk management solutions to help manage foreign exchange exposure from its day-to-day business activities. Corpay Cross-Border’s award-winning platform will also enable Ultimate Sevens to manage global payments through a single point of access. “Corpay Cross-Border is thrilled to be named the exclusive and official FX partner of Ultimate Sevens,” said Brad Loder,
TestMu AI Makes Samsung Galaxy Z Fold8 and Galaxy Z Fold8 Ultra Available on Real Device Cloud Ahead of Retail Launch5.8.2026 14:30:00 CEST | Press release
Developers can test websites and mobile apps on Samsung's newest foldables, running Android 17, before the devices reach customers TestMu AI (formerly LambdaTest), the world's first full-stack Agentic AI Quality Engineering platform, announced that the Samsung Galaxy Z Fold8 and Galaxy Z Fold8 Ultra are now available for testing on its Real Device Cloud. Both devices, unveiled at Samsung's Galaxy Unpacked event, run Android 17 with One UI 9 and are accessible for live testing and automation before retail units reach customers. The launch generation introduces a testing challenge new to the Galaxy Z Fold line. The Galaxy Z Fold8 unfolds into a portrait-oriented 7.6-inch display, while the Galaxy Z Fold8 Ultra, the first Ultra model in the Z series, unfolds into a landscape-oriented 8.0-inch display. Two devices that share a name, a chipset, and an operating system present layouts with opposite orientations, which means an interface validated on one can break on the other. "Samsung has i
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
