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11/04/21

Abstracts at the Annual Meetings of the American Society of Nephrology and American College of Rheumatology Highlight Potential Value of TAVNEOS™ (avacopan)

SAN CARLOS, Calif., Nov. 04, 2021 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced the abstracts accepted for presentation and publication as part of the annual meetings of the American Society of Nephrology (ASN) Kidney Week 2021 and American College of Rheumatology (ACR) Convergence 2021, taking place November 2-7, 2021 and November 3-9, 2021, respectively.

American Society of Nephrology (ASN) Kidney Week

Effect of Avacopan, a Selective C5a Receptor Inhibitor, on C3G Histologic Index of Disease Chronicity

Session: Late-Breaking Clinical Trials Posters [PO2539]

Posted online on November 4, 2021, 10:00 AM PDT.

Presented by: Andrew S. Bomback, M.D., Columbia University Medical Center

Complement C5a Receptor in Macrophage-Mediated Renal Inflammation and Fibrosis in Lupus Nephritis

Session: CKD: Inflammation, Endothelial Dysfunction, and Signaling [PO2451]

November 4, 2021 Abstract Time: 10:00 AM - 12:00 PM PDT (On-Demand, Virtual Only)

Conclusion: C5aR activation induced macrophage secretion of factors that are known to drive inflammation, fibroblast activation and tissue fibrosis, and thus may contribute to lupus nephritis disease progression. Inhibiting C5aR activity with avacopan blocks these pathological changes, and may provide therapeutic benefit to lupus nephritis patients.

Effect of Avacopan, a Selective C5a Receptor Inhibitor, on Kidney Function in Patients with ANCA-Associated Vasculitis

Session: High-Impact Clinical Trials [FR-OR63]

November 5, 2021 Abstract Time: 11:00 AM - 11:15 AM PDT (Live-Stream)

Presented by: David R.W. Jayne, M.D., University of Cambridge

Safety and Efficacy of Avacopan (CCX168) in a Pediatric Patient with C3 Glomerulopathy

Publication Only [PUB226]

Discussion: To the best of our knowledge, this is the first report on the use of avacopan in a pediatric case of C3 glomerulonephritis.

American College of Rheumatology (ACR) Convergence

The Effect of Treatment with the Complement C5a Receptor Inhibitor Avacopan on Health-Related Quality of Life in ANCA-Associated Vasculitis

Session: Abstracts: Vasculitis – ANCA-Associated [0955]

November 7, 2021 Abstract Time: 9:45 AM - 9:55 AM ET

Presented by: Vibeke Strand, M.D., Stanford University School of Medicine

Conclusion: Treatment of ANCA-Associated Vasculitis with avacopan and a reduced-dose glucocorticoid regimen led to significant improvements in health-related quality of life (HRQoL) compared to standard of care (SOC). These findings have important clinical implications for treatment of patients with ANCA-Associated Vasculitis.

Effect of Avacopan, a Selective C5a Receptor Inhibitor, on Kidney Function in Patients with ANCA-Associated Vasculitis

Session: Late-Breaking Posters [L14]

November 9, 2021 Abstract Time: 8:30 AM10:30 AM ET

Presented by: David R.W. Jayne, M.D., University of Cambridge

Conclusion: Patients with ANCA-associated vasculitis in the avacopan group had greater recovery of kidney function compared to patients in the prednisone group, especially among patients with chronic kidney disease Stage 4 and those with eGFR < 60 mL/min/1.73 m2 and urinary abnormalities at baseline.

INDICATION

TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Serious hypersensitivity to avacopan or to any of the excipients

WARNINGS AND PRECAUTIONS
Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for six months and as clinically indicated thereafter. Monitor patients closely for hepatic adverse reactions, and consider pausing or discontinuing treatment as clinically indicated (refer to section 5.1 of the Prescribing Information). TAVNEOS is not recommended for patients with active, untreated and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risk and benefit before administering this drug to a patient with liver disease.

Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including one serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be re-administered unless another cause has been established.

Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for six months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming.

Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection or who have been to places where certain infections are common.

ADVERSE REACTIONS
The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were: nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia.

DRUG INTERACTIONS
Avoid coadministration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor for adverse reactions and consider dose reduction of certain sensitive CYP3A4 substrates.

Please see Full Prescribing Information  and Medication Guide for TAVNEOS.

About TAVNEOS™ (avacopan)

TAVNEOS (avacopan), approved by the FDA as an adjunctive treatment of ANCA-associated vasculitis, is a first-in-class, orally-administered small molecule that employs a novel, highly targeted mode of action in complement-driven autoimmune and inflammatory diseases. While the precise mechanism in ANCA vasculitis has not been definitively established, TAVNEOS, by blocking the complement 5a receptor (C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils, is presumed to arrest the ability of those cells to do damage in response to C5a activation, which is known to be the driver of ANCA vasculitis. TAVNEOS’s selective inhibition of only the C5aR leaves the beneficial C5a pathway through the C5L2 receptor functioning normally.

ChemoCentryx is also developing TAVNEOS for the treatment of patients with C3 glomerulopathy (C3G), hidradenitis suppurativa (HS) and Lupus Nephritis (LN). The U.S. Food and Drug Administration granted TAVNEOS orphan drug designation for ANCA-associated vasculitis and C3G. The European Commission has granted orphan medicinal product designation for TAVNEOS 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.

TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use. TAVNEOS has not been approved for indications discussed as in development, and the safety and efficacy of TAVNEOS for those uses has not been established.

About ChemoCentryx

ChemoCentryx is a biopharmaceutical company commercializing and developing new medications for inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally-administered therapies. In the United States, ChemoCentryx markets TAVNEOS™ (avacopan), the first approved orally-administered inhibitor of the complement 5a receptor as an adjunctive treatment for adult patients with severe active ANCA-associated vasculitis. TAVNEOS is also in late-stage clinical development for the treatment of severe Hidradenitis Suppurativa and C3 glomerulopathy (C3G). Additionally, ChemoCentryx has early-stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer. For more information visit www.chemocentryx.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, whether TAVNEOS will be shown to be effective in the treatment of Hurley Stage 3 (severe) HS and C3G and whether the Company's drug candidates, including CCX559, 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 1, 2021 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.

Contacts:
Susan M. Kanaya
Executive Vice President,
Chief Financial and Administrative Officer
investor@chemocentryx.com

Media:
Stephanie Tomei
408.234.1279
media@chemocentryx.com

Investors:
Burns McClellan
Lee Roth
212.213.0006
lroth@burnsmc.com


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Source: ChemoCentryx, Inc.