- Thinly traded micro cap ChemoCentryx (NASDAQ:CCXI) is up 24% premarket on light volume in response to its announcement of positive results from a Phase 2 clinical trial assessing lead product candidate, CCX168, in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis or AAV, a rare autoimmune inflammation caused by auto-antibodies.
- The study, called CLEAR, was designed to assess whether treatment with CCX168 could enable the reduction or elimination of high-dose chronic steroids, the current standard-of-care (SOC) treatment for AAV. The trial met its primary endpoint of demonstrating statistically significant non-inferiority (p=0.005) to SOC at week 12 as measured by an AAV assessment scale called Birmingham Vasculitis Activity Score (BVAS). It also showed a more repid onset of action, improvements in kidney function and quality of life metrics.
- AAV, affecting ~40K Americans, is characterized by damage to the small blood vessels caused by the activity of inflammatory leukocytes, specifically, white blood cells called neutrophils. Any organ can be affected, but primarily AAV harms the kidneys, lungs and ear/nose/throat.
- CCX168 targets a receptor for a protein called C5a, which is involved with the priming and activation of neutrophils. Binding to the receptor blocks C5a activity which reduces neutrophil activity which, in turn, reduces vasculitis.
- The clinical development of CCX168 is ongoing.