Corcept Depression Drug Misses Primary Endpoint
Posted on: Tuesday, 20 March 2007, 15:01 CDT
Corcept Therapeutics has reported that a late-stage trial to evaluate its depression drug Corlux failed to reach its main goal but there was a statistically significant correlation between plasma levels and clinical outcome achieved during treatment.
The last of three phase III trials evaluating Corlux for treating the psychotic features of psychotic major depression (PMD), did not achieve statistical significance compared to placebo. However, patients whose plasma levels rose above a predetermined threshold statistically separated from both those whose plasma levels were below the threshold and those patients who received placebo.
"While we are disappointed that the trial did not meet the primary endpoint, we are particularly encouraged to have met the important predefined threshold concentration endpoint with statistical significance," said Joseph Belanoff, Corcept's CEO. "This study confirms our previous observation that at higher plasma levels the drug candidate is able to demonstrate desired clinical effects."
The company is now planning another phase III study for later in 2007, in which it will use a dose level of 1200 mg once per day for seven days. Corcept said that it believes that the change in dose as well as other modifications to the protocol should allow the company to definitively demonstrate the efficacy of Corlux in the treatment of the psychotic features of PMD.
Source: Datamonitor
Related Articles
- British Airways World Cargo to Reduce Fuel Surcharge
- Daxor Announces Publication of Blood Volume Research Study By Vanderbilt University and National Institutes of Health Concerning Chronic Mountain Sickness Utilizing the BVA-100 Blood Volume Analyzer
- Lung CD4 Lymphocytes Predict Survival in Asymptomatic HIV Infection*
- ISA, ISSAM and EAU Recommendations for the Investigation, Treatment and Monitoring of Late-Onset Hypogonadism in Males: Scientific Background and Rationale
- Relationship Between Release of Platelet/Endothelial Biomarkers and Plasma Levels of Sertraline and N-Desmethylsertraline in Acute Coronary Syndrome Patients Receiving SSRI Treatment for Depression
- Time Since Menopause Does Not Affect Plasma Viscosity, Plasma Thromboxane Levels and Doppler Findings
- Chronically Elevated Endothelin Levels Reduce Pulmonary Vascular Reactivity to Nitric Oxide
- Transdermal Hormone Replacement Therapy and Doppler Findings in Normal and Overweight Postmenopausal Patients
- Antioxidant Intake in Pregnancy in Relation to Wheeze and Eczema in the First Two Years of Life
- Foxo1 Mediates Insulin Action on apoC-III and Triglyceride Metabolism
 |
 |
User Comments (0)
RSS Feeds