ChemoCentryx Announces Plenary Session at ACR Convergence 2020 to Highlight Findings of ADVOCATE Phase III Trial in ANCA-Associated Vasculitis

Rhea-AI Summary

ChemoCentryx, Inc. (Nasdaq: CCXI) announced today at ACR Convergence 2020 Phase III trial results for its drug candidate avacopan, highlighting its effectiveness in treating ANCA-associated vasculitis. Avacopan achieved statistical superiority over standard prednisone therapy, sustaining remission at 52 weeks and improving renal function. The FDA is currently reviewing a New Drug Application (NDA) for avacopan, with a goal date set for July 7, 2021. The ADVOCATE trial involved 331 patients across 20 countries, showcasing avacopan's potential for better long-term outcomes.

Positive

• Avacopan demonstrated statistical superiority in sustaining remission at 52 weeks compared to prednisone.
• Greater improvement in renal function with avacopan treatment.
• The FDA is reviewing the NDA for avacopan, expected to be decided by July 7, 2021.
• The ADVOCATE trial included 331 patients from 20 countries, reinforcing the drug's efficacy.

Negative

• None.

-- Study Showed Treatment with Avacopan Achieved Statistical Superiority in Sustaining Remission at 52 Weeks and Greater Improvement in Renal Function Compared to the Prednisone Group --

MOUNTAIN VIEW, Calif., Nov. 06, 2020 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that ACR Convergence 2020 -- the virtual annual meeting of the American College of Rheumatology -- will feature a plenary session presentation today on the ADVOCATE Phase III trial results of the Company’s lead drug candidate avacopan, an orally administered complement 5a receptor inhibitor, in the treatment of ANCA-associated vasculitis. A New Drug Application (NDA) for avacopan in ANCA-associated vasculitis is under review by the U.S. Food and Drug Administration.

The Effect on Renal Function of the Complement C5a Receptor Inhibitor Avacopan in
ANCA-Associated Vasculitis

• Today, Friday, November 6, 2020 (Abstract: 0432) as part of Plenary Session I (0429–0433) from 11:30 a.m. to 1:00 p.m. ET
• Presented by Peter Merkel, M.D., MPH, from the Hospital of the University of Pennsylvania

The presentation will highlight the results from the randomized, double-blind Phase III ADVOCATE trial, which compared treatment with avacopan head-to-head with standard daily glucocorticoid (prednisone) therapy. The study showed that avacopan was as effective as prednisone therapy in bringing patients into remission by 26 weeks, and superior to prednisone for sustained remission after 52 weeks. In addition, the avacopan group had greater improvement in renal function compared to standard prednisone therapy.

As noted in the authors’ conclusion, “These findings suggest the potential for better long-term outcomes with avacopan for patients with renal disease than current standard of care treatment and provide intriguing insights into subclinical renal disease activity in ANCA-associated vasculitis.”

About ADVOCATE and ANCA-Associated Vasculitis
The ADVOCATE trial of avacopan was a global, randomized, double-blind, active-controlled, double-dummy Phase III trial of 331 patients with ANCA-associated vasculitis in 20 countries. Eligible study subjects were randomized to receive avacopan plus either rituximab or cyclophosphamide (followed by azathioprine/mycophenolate) or prednisone plus either rituximab or cyclophosphamide (followed by azathioprine/mycophenolate).

ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is fatal if not treated. Currently, treatment for ANCA-associated vasculitis consists of courses of non-specific immuno-suppressants (cyclophosphamide or rituximab), combined with the administration of daily glucocorticoids (steroids) for prolonged periods of time, which can be associated with significant clinical risk including death from infection.

About Avacopan
Avacopan is a first-in-class, orally-administered small molecule that employs a novel, highly targeted mode of action in the treatment of ANCA-associated vasculitis and other complement-driven autoimmune and inflammatory diseases. By precisely blocking the receptor (the C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils, avacopan arrests the ability of those cells to do damage in response to C5a activation, which is known to be the driver of ANCA-associated vasculitis. Current therapies for ANCA-associated vasculitis and other related illnesses typically include broad immunosuppression with daily doses of glucocorticoids (steroids) such as prednisone or methylprednisone, which can cause significant illness and even death. Avacopan therapy was designed to prevent these outcomes. Moreover, avacopan’s selective inhibition of only the C5aR leaves the beneficial C5a pathway through the C5L2 receptor functioning normally.

The U.S. Food and Drug Administration (FDA) is evaluating a New Drug Application (NDA) for avacopan for the treatment of ANCA-associated vasculitis and has set a Prescription Drug User Fee Act (PDUFA) goal date of July 7, 2021.

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. 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.

ChemoCentryx's Kidney Health Alliance with Vifor Pharma provides Vifor Pharma with exclusive rights to commercialize avacopan in markets outside of the U.S.

About ChemoCentryx
ChemoCentryx is a biopharmaceutical company 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. ChemoCentryx’s lead drug candidate, avacopan (CCX168), successfully completed a pivotal Phase III trial in ANCA-associated vasculitis and a New Drug Application is under review by the U.S. Food and Drug Administration. Avacopan is also in late stage clinical development for the treatment of Hidradenitis Suppurativa and C3 glomerulopathy (C3G).

ChemoCentryx also has early stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer.

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 timing of anticipated PDUFA date for the avacopan NDA for the treatment of ANCA-associated vasculitis, the achievement of anticipated goals and milestones, whether avacopan will be approved by the FDA for the treatment of ANCA-associated vasculitis, whether avacopan will be an effective treatment in other indications such as C3G or HS, 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.

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, Inc.
Steve Klass
212.213.0006
sklass@burnsmc.com 

FAQ

What are the results of the ADVOCATE trial for avacopan (CCXI)?

The ADVOCATE trial results indicate that avacopan achieved statistical superiority over prednisone, sustaining remission at 52 weeks.

How does avacopan compare to prednisone in treating ANCA-associated vasculitis?

Avacopan was found to be as effective as prednisone at achieving remission at 26 weeks but superior for sustained remission and renal function improvement at 52 weeks.

What is the FDA status of avacopan for ANCA-associated vasculitis?

The FDA is currently reviewing a New Drug Application (NDA) for avacopan, with a decision expected by July 7, 2021.

How many patients were involved in the ADVOCATE trial of avacopan?

The ADVOCATE trial involved 331 patients across 20 countries.

What is the significance of avacopan in treating ANCA-associated vasculitis?

Avacopan offers the potential for better long-term outcomes than standard glucocorticoid treatments, reducing risks associated with such therapies.