Menlo Park, CA's Corcept ($CORT) watched its shares roughly halve Wednesday morning after it pulled the plug on a late-stage trial of an investigational depression treatment.
Looking at interim data on 266 patients in a planned 450-subject study, Corcept's independent monitoring committee said the in-development mifepristone wasn't meeting its primary endpoint of reducing psychotic symptoms in depression sufferers, and it was unlikely to do so if the trial kept rolling. Corcept has decided to cut its losses on the program, shifting its focus to more promising applications for its lead prospect.
Mifepristone works by blocking the glucocorticoid receptor type II, stopping the steroid cortisol from proliferating in the body. In 2012, the drug won FDA approval to treat the orphan of Cushing's disease, which affects about 20,000 patients in the U.S., and Corcept is counting on an ambitious clinical program to deliver more indications for its star treatment.
|Corcept CEO Joseph Belanoff|
The Phase III depression flop is a major setback toward that goal, sending Corcept's shares down more than 50% to about $2 on Wednesday. But CEO Joseph Belanoff is staying optimistic, pointing to a Phase I trial of mifepristone for the treatment of triple-negative breast cancer, for which efficacy results are expected in the first half of next year.
"Although the interim results of our psychotic depression study are disappointing, our own research and the research of academic investigators has shown that glucocorticoid receptor antagonism has therapeutic potential in many serious diseases," Belanoff said in a statement. "... In addition, many other clinical studies are underway at leading academic institutions to test the effectiveness of mifepristone and our newer compounds in various indications. We expect that 2014 will be a busy and productive year."
Mifepristone, which Corcept markets as Korlym, brought in $4.4 million in revenue last quarter, and the biotech expects it to gross up to $29 million on the year.
- read the statement