Their Phase III study evaluated the response of two patient groups receiving Corlux; those patients who were glucose intolerant and those who were hypertensive. Corcept saw statistically significant improvements in the primary endpoint for both groups, with 60% responding in the glucose intolerant group and 43% in the hypertensive group. Corlux was well-tolerated and appears to offer these patients some hope. Note that 90% of the patients who completed the Phase III study opted to enter the long-term extension study. Data on the secondary endpoint (global clinical improvement) is expected to be available in the first quarter of 2011. For orphan diseases like Cushing’s, secondary endpoints are very important and if Corlux still demonstrates efficacy, it will lower the regulatory risk and make their program much more attractive.
“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 and continue to work toward our goal of making Corlux available to patients with this severe disease,” Joseph Belanoff, M.D., chief executive officer of Corcept said.
CORT has a shelf registration statement to raise up to $100 million, which we think could come sometime after the NDA is filed, in order to support commercialization activities in Cushing's. However, the shelf may not be needed if they can find a European partner over the next few months. We will be watching this in the hopes of positive news like a partnership and the secondary endpoint/completed safety data.
Disclosure: No position