-- Supports plans to advance TAVNEOS®(avacopan) into Phase III development for the treatment of patients with most severe form of hidradenitis suppurativa, Hurley Stage III --
SAN CARLOS, Calif., May 18, 2022 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced that a poster will be presented at the Society for Investigative Dermatology (SID) 2022 Annual Meeting, to be held May 18-21, 2022 in Portland, Oregon, that highlights unique immunological profiles of the subdermal tunnels in hidradenitis suppurativa, and how these profiles are differentiated with the stage of disease severity. The findings support the Company’s plans to advance TAVNEOS® (avacopan) into Phase III development for the treatment of patients with Hurley Stage III (severe) hidradenitis suppurativa.
The poster titled, Spatial Transcriptomic Analysis of HS Skin Lesions Reveals that Tunnels are Immunologically Active and Activity Correlates with Disease Severity, will be presented as part of Poster/Exhibit Hall Session 2 on Friday, May 20 between 4:30 PM– 6:30 PM PT.
Hidradenitis suppurativa (HS) is a chronic, disabling, inflammatory skin disease characterized by neutrophil-rich inflammatory nodules, abscesses, and tunnels (sinus tracts). Complement dysregulation and neutrophil activation have been implicated in the pathogenesis of HS. The complement 5a (C5a) receptor (C5aR) is highly expressed on neutrophils and is a major driver of the pro-inflammatory functions. Clinical assessment of the severity of HS includes staging using the Hurley system, where Hurley Stage III disease defines severe HS and Hurley Stage II denotes a more moderate disease presentation.
At the SID 2022 Annual Meeting, ChemoCentryx will present data that show a marked increase in dermal inflammation in severe Hurley Stage III HS lesions compared to moderate Hurley II lesions. Genes for proinflammatory cytokines, chemokines, neutrophil activation factors, and B cells had higher expression in the severe compared to moderate HS lesions. The spatial gradients of cytokine and chemokine gene expression support the idea that more differentiated tunnels in Hurley III disease are intensely immunologically active, potentially contributing to ongoing active severe disease, rather than merely remnant structures of prior disease.
TAVNEOS, a potent and specific inhibitor of human C5aR, was previously evaluated in the Phase II AURORA clinical trial in patients with moderate Hurley Stage II or severe Hurley Stage III HS. The data now presented at the SID meeting support and extend the Company’s earlier findings showing increased presence of C5a- and C5aR-bearing cells in Hurley Stage III skin biopsies relative to Hurley II samples, and also provide further mechanistic evidence underpinning TAVNEOS’s efficacy in patients with severe HS after 12 weeks of treatment in the AURORA trial.
ChemoCentryx plans to meet with the FDA to discuss the Phase III development of TAVNEOS in patients with Hurley Stage III (severe) HS late in the second quarter, with the goal of initiating a Phase III clinical trial in those patients in the second half of 2022.
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 is believed to leave the beneficial C5a pathway through the C5L2 receptor functioning normally.
ChemoCentryx is also developing TAVNEOS for the treatment of patients with C3 glomerulopathy (C3G), severe hidradenitis suppurativa (HS) and Lupus Nephritis (LN). The US 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 has not been approved for indications discussed as in development, and the safety and efficacy of those uses has not been established.
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 (HS) 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 about the Company visit www.chemocentryx.com.
TAVNEOS® is a registered trademark of ChemoCentryx, Inc. For more information, please see the Full Prescribing Information and Medication Guide, available at TAVNEOS.com.
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 a development path forward will be established for TAVNEOS in the treatment of severe hidradenitis suppurativa (HS), the timing of initiating Phase III clinical development, and whether TAVNEOS will be shown to be effective in the treatment of severe HS in 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, 2022, 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.
Bill Slattery, Jr.
Vice President, Investor Relations
& Corporate Communications
Source: ChemoCentryx, Inc.