Business Wire

CA-VIFOR-PHARMA

18.5.2020 07:02:06 CEST | Business Wire | Press release

Share
VFMCRP and ChemoCentryx announce topline data from phase-II LUMINA-1 trial of CCX140 in Focal Segmental Glomerulosclerosis (FSGS)

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.

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

Vercel Appoints Amit Agarwal, Standard Template Labs CEO and former Datadog President, to Board of Directors6.8.2026 17:00:00 CEST | Press release

The product leader who helped scale Datadog from early-stage startup through IPO brings deep product expertise to Vercel's board Vercel, the agentic infrastructure company, today announced the appointment of Amit Agarwal, former president of Datadog and founder and CEO of Standard Template Labs, an AI-first service management platform, to its board of directors. Agarwal brings 25 years of enterprise software experience and a track record of scaling a product-led company from its earliest days into one of the defining public software companies of the cloud era. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806738617/en/ Amit Agarwal Agarwal joined Datadog in 2012 as its Chief Product Officer and was named President in 2022, overseeing product, corporate development, and go-to-market functions as the company grew past $2.5 billion in annual revenue. Across 13 years, including Datadog's 2019 IPO and its first years as a pub

Laserfiche Launches Advanced Enterprise Security to Deliver Multi-Region Disaster Recovery and GovRAMP-Ready Compliance for Highly Regulated Industries6.8.2026 16:00:00 CEST | Press release

New security suite extends Laserfiche’s proven security controls and adds near real-time data replication for governments, law enforcement and security-conscious enterprises. Laserfiche — the leading SaaS provider of intelligent content management — today announced the launch of Enterprise Security, an advanced suite of security enhancements designed for organizations navigating complex regulatory environments. Enterprise Security addresses GovRAMP and CJIS (Criminal Justice Information Services) security requirements based on the NIST SP 800-53 framework. For organizations handling privileged citizen, legal or corporate data, these built-in controls streamline audit preparation and fortify defenses. With organizations placing a higher priority on data stewardship and corporate governance, enterprise IT leaders require a security architecture that protects data without slowing down operations. Laserfiche Enterprise Security extends Laserfiche Cloud’s highly resilient infrastructure wit

AM Best Upgrades Fortegra Insurance Subsidiaries to A (Excellent)6.8.2026 15:00:00 CEST | Press release

Rating actions follow completion of the DB Insurance acquisition The Fortegra Group, Inc. (“Fortegra” or the “Company”), a global specialty insurer and part of DB Insurance Co., Ltd., today announced that AM Best has upgraded the Financial Strength Rating (FSR) of its insurance subsidiaries to A (Excellent) from A- (Excellent) and the Long-Term Issuer Credit Ratings (Long-Term ICRs) to “a” (Excellent) from “a-” (Excellent). The outlook assigned to the ratings is stable, and AM Best removed the ratings from under review with positive implications. KBRA has also upgraded all of its ratings for the Company. The upgrade applies across Fortegra’s insurance platform. The property and casualty companies include Lyndon Southern Insurance Company, Insurance Company of the South, Response Indemnity Company of California, Blue Ridge Indemnity Company, Fortegra Specialty Insurance Company and Fortegra Europe Insurance Company SE. The life and health companies include Life of the South Insurance Co

Khimji Ramdas Group Chooses Rimini Street to Reduce SAP Support Costs, Protect 700+ Customizations and Reinvest Savings in Innovation6.8.2026 15:00:00 CEST | Press release

Omani conglomerate gains greater control over its IT roadmap, avoids migration pressure and funds AI and growth initiatives Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced that Khimji Ramdas Group, one of Oman’s largest privately held conglomerates, has selected Rimini Support™ for SAP, a move that has helped the organization reduce costs, reinvest savings in AI innovation and maintain its highly customized SAP ECC 6 environment with zero downtime. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806244148/en/ Khimji Ramdas Group Chooses Rimini Street to Reduce SAP Support Costs, Protect 700+ Customizations and Reinvest Savings in Innovation “Staying on SAP ECC is a strategic decision for us,” said Prashant Kumar, CTO, Khimji Ramdas Group. “We went to an industry analyst to ask what options

Naser Taher, Chairman and Founder of MultiBank Group, Honored by H.H. Sheikh Nahyan bin Mubarak Al Nahyan with the Golden Excellence Award for FinTech, Digital Asset and Blockchain Excellence6.8.2026 14:53:00 CEST | Press release

The recognition honors Naser Taher and MultiBank Group for its revolutionary advances in regulated digital assets, blockchain, and real-world asset tokenization Naser Taher, Chairman and Founder of MultiBank Group, has been honored with the Golden Excellence Award for FinTech, Digital Asset and Blockchain Excellence at the 9th Golden Excellence Awards 2026. The award was presented by H.H. Sheikh Nahyan bin Mubarak Al Nahyan, UAE Cabinet Member and Minister of Tolerance & Coexistence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806828617/en/ Naser Taher, Chairman and Founder of MultiBank Group, Honored by H.H. Sheikh Nahyan bin Mubarak Al Nahyan with the Golden Excellence Award for FinTech, Digital Asset and Blockchain Excellence. The recognition reflects MultiBank Group’s continued expansion into regulated digital assets through mb.io, the Group’s VARA-regulated cryptocurrency exchange. Through mb.io, clients can acces

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye