* Cushing’s Syndrome drug succeeds in late-stage trial
* Co plans to file for approval in late Q1
* Says drug was generally well tolerated
Dec 22 (Reuters) - Corcept Therapeutics Inc (CORT.O) said a late-stage trial of its experimental drug for a hormone disorder met the main study goal of showing statistically significant improvement in glucose tolerance and blood pressure.
The company is planning to submit a marketing approval application to U.S. regulators late in the first quarter of 2011.
The late-stage study tested the drug Corlux in two patient groups -- glucose intolerant and hypertensive.
The hormone disorder, called Cushing’s syndrome, is caused by unusually high levels of cortisol -- a steroid hormone produced by the adrenal gland -- in blood. .
The 50-patient trial had 60 percent patients responding to the treatment in the first group and 43 percent in the second.
Initial analyses show the drug was well tolerated by the trial population, the company said.
Adverse events related to treatment included symptoms of adrenal insufficiency, endometrial thickening and hypokalemia.
Corlux was granted an orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of Cushing’s Syndrome in 2007.
The status is granted by the FDA to drugs or biologics that treat a condition affecting less than 200,000 Americans. The status grants the drugmaker a marketing exclusivity of seven years in the United States, upon approval. (Reporting by Esha Dey in Bangalore; Editing by Joyjeet Das)