Corcept's Corlux misses Ph III endpoint in PMD

US drugmaker Corcept Therapeutics says that Study 06, the last of three Phase III trials evaluating its lead drug candidate Corlux (mifepristone), a potential agent for the psychotic features of psychotic major depression, did not achieve statistical significance on its primary endpoint.

However, the California-headquartered firm said there was a statistically-significant correlation between plasma levels and clinical outcome achieved during treatment. Further, the company reported that the incidence of serious adverse events did not differ between placebo and any of the three Corlux dose groups, and the firm is going to continue the drug's development in this indication.

Patients whose plasma levels rose above a predetermined threshold statistically separated from both those whose plasma levels were below the threshold and those subjects who received placebo. This confirmed a similar finding in Study 07, another Phase III trial testing Corlux for PMD completed in 2006.