A year after former partner GlaxoSmithKline ($GSK) closed the door on what could have been a $1.5 billion collaboration, Mountain View, CA's ChemoCentryx ($CCXI) is touting a Phase II victory for its kidney disease treatment, news that promptly doubled its share value.
The drug, CCX140, is designed to treat diabetic nephropathy, which is the leading cause of end-stage renal disease and often spurs the need for dialysis or kidney transplantation. In a Phase II trial on 332 subjects, the oral treatment met its primary endpoint of significantly reducing patients' urinary albumin creatinine ratio (UACR), the company said, moving the needle on a key predictor of future kidney trouble. ChemoCentryx paired its drug with the standard of care--generic blood pressure medications--and tested the combination against those treatments alone, finding that a 5 mg dose of CCX140 led to a sustained reduction in UACR over 52 weeks.
Now ChemoCentryx is turning its attention to estimated glomerular filtration rate (eGFR), a measure of kidney function likely to come into play as the company maps out endpoints for a pivotal trial. CCX140 slowed the rate of eGFR decline in the Phase II study compared to standard of care alone, ChemoCentryx said, and management sees that as promising signal as it moves toward Phase III.
|Dick de Zeeuw|
"Even with optimal current care, the residual risk in diabetic nephropathy patients for further decrease in renal function is still extremely high," Dick de Zeeuw, University Medical Center Groningen professor and CCX140 investigator, said in a statement. "... These robust results with CCX140, in this context, are extremely relevant and promising, particularly if translated into preservation of renal function. CCX140 should definitely be tested in a Phase III trial."
The biotech's shares jumped as much as 120% on Friday morning, reaching their highest value since August 2013, the eve of a big Phase III failure that helped convince GSK to abandon the company. CCX140 was never part of ChemoCentryx's multicandidate deal with GSK.
Despite the positive response, the latest top-line data may not assuage long-standing worries that CCX140 will struggle to markedly differentiate itself from placebo. The issue first cropped up last year, when ChemoCentryx unveiled 12-week results from its Phase II study in which the drug's comparative effect was murky at best, sending the company's shares down more than 20%. In its latest results, ChemoCentryx heralds a positive signal but doesn't disclose detailed data, leaving room for questions about CCX140's ultimate efficacy.
- read the results