Shares of Corcept Therapeutics shot up after the developer announced it had reaped some promising top-line data points from its Phase III study of a new drug for Cushing's syndrome, leaving the Menlo Park, CA-based biotech on track to file for regulatory approval in the first quarter.
Investigators report that 60 percent of the patients with glucose intolerance responded to Corlux, and a 43 percent response rate was tracked in a hypertensive group. Cushing's syndrome is caused by prolonged exposure of the body's tissues to high levels of the hormone cortisol and is generated by tumors that produce cortisol or ACTH. Only 50 patients were recruited for the study, which is not unusual for an orphan indication.
In the glucose-intolerant group, a responder was defined as a patient who achieved a 25 percent or greater improvement in glucose tolerance at 24 weeks compared to baseline. In the hypertension group, a responder was defined as a patient who achieved a five millimeter or greater improvement in diastolic blood pressure at 24 weeks compared to baseline.
"The results of the study demonstrate that Corlux has the potential to become an important treatment option for patients suffering from Cushing's Syndrome," said Corcept CEO Joseph Belanoff. "We remain on track to submit a New Drug Application to the FDA for Corlux in Cushing's Syndrome by the end of the first quarter of 2011."
- here's the Corcept release
- check out the Reuters report