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ChemoCentryx Announces Positive Topline Results of Phase II AURORA Clinical Trial of Avacopan in the Treatment of Hidradenitis Suppurativa (HS)
-- Avacopan demonstrates statistically significant dose-dependent improvement in HiSCR (Hidradenitis Suppurativa Clinical Response) vs. placebo in
About this update from Chemocentryx Inc.
[{"type":"text","content":"-- Avacopan demonstrates statistically significant dose-dependent improvement in HiSCR (Hidradenitis Suppurativa Clinical Response) vs. placebo in pre-specified Hurley Stage III (severe HS) patients at 12 weeks; numerical improvement observed with avacopan treatment in overall study population --\n -- Consistent reduction in Hurley Stage III patients in International HS Severity Score (IHS4), as well as reduction in AN (abscesses and inflammatory nodules), draining fistula, and abscess count at week 12 -- -- Avacopan shown to be safe and well tolerated in HS patients -- -- Company plans to pursue Phase III development for avacopan in Hurley Stage III (severe HS) patients -- -- Conference call today at 4:30 p.m. Eastern Time -- MOUNTAIN VIEW, Calif., Oct. 28, 2020 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced positive topline data from the Company’s AURORA randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial of avacopan for the treatment of the chronic disabling skin disease Hidradenitis Suppurativa (HS). Avacopan is a first-in-class, orally-administered selective inhibitor of the complement C5a receptor. The Phase II AURORA clinical trial randomized 398 patients to one of three treatment arms. The study population included patients with moderate HS (Hurley Stage II) or severe HS (Hurley Stage III), which were stratified evenly across the treatment groups. The primary endpoint of the proportion of all patients (both moderate Hurley Stage II plus severe Hurley Stage III) achieving Hidradenitis Suppurativa Clinical Response (HiSCR), as assessed 10 mg twice-daily (BID) and 30 mg BID dosing regimens of avacopan against placebo after 12 weeks of treatment in the combined study population, was not achieved with statistical significance at either dose level, although a numerical improvement was noted at the 30mg BID dose. Importantly, avacopan 30mg BID demonstrated a statistically significant higher response than placebo in the pre-specified population of Hurley Stage III (severe) HS patients in the study. The Company plans to advance avacopan into Phase III development for the treatment of severe HS. Table 1: Hidradenitis Suppurativa Clinical Response (HiSCR) Results PlaceboAvacopan 10 mg BIDAvacopan 30 mg BID n/N (%)n/N (%)∆ %(95% CI)n/N (%)∆ %(95% CI)All40/130 (30.8)30/134 (22.4...