ChemoCentryx reported positive topline results from the phase 2 AURORA trial which evaluated the efficacy of avacopan versus placebo in patients with moderate Hidradenitis Suppurativa (Hurley Stage II) or severe Hidradenitis Suppurativa (Hurley Stage III). Avacopan demonstrated a statistically significant dose-dependent improvement in HiSCR (Hidradenitis Suppurativa Clinical Response) versus placebo in pre-specified Hurley Stage III patients at 12 weeks. Numerical improvements were observed with avacopan treatment in overall study population.
AURORA was a randomized, double-blind, placebo-controlled, multi-center trial and enrolled 398 patients with moderate-to-severe HS to one of three treatment arms. The primary endpoint assessed 10 mg twice daily (BID) and 30 mg BID dosing regimens of avacopan against placebo at 12 weeks of treatment, using the HiSCR scale. HiSCR response is defined as a ≥ 50% reduction in inflammatory lesion count (abscesses + inflammatory nodules), and no increase in abscesses or draining fistulas when compared with baseline.
The primary endpoint was not achieved with statistical significance at either dose level, although a numerical improvement was noted at the 30mg BID dose. 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. A consistency of effect with avacopan was noted in Hurley Stage III patients across every secondary endpoint assessed to date. Favorable reductions for avacopan were observed in International HS Severity Score (IHS4), as well as reduction in AN (abscesses and inflammatory nodules), draining fistula, and abscess count at week 12 (all % change from baseline to week 12), relative to placebo.
Based on this data, the Company plans to advance avacopan into Phase III development for the treatment of severe HS.
Avacopan 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. 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. Moreover, avacopan’s selective inhibition of only the C5aR leaves the beneficial C5a pathway through the C5L2 receptor functioning normally.
About Hidradenitis Suppurativa (HS)
Hidradenitis Suppurativa, also known as acne inversa, is a chronic disabling autoimmune skin disease characterized by recurrent, painful nodules, boils and abscesses.