By Brady Huggett
Corcept Therapeutics Inc., beneath the level of the biotechnology industry¿s radar since its inception in 1999, surfaced with the news of a $27 million Series C financing and said it will initiate Phase III trials for its lead product, C-1073, in a matter of weeks.
Joseph Belanoff, CEO of privately held Corcept, said the money will be used for the development of C-1073, also known as RU 486, or by its generic name, mifepristone, for psychotic major depression.
¿The funds will be used for our Phase III studies,¿ Belanoff told BioWorld Today. ¿It¿s enough to do our Phase III work and some prelaunch activities. I think it will last on the order of 18 months to two years.¿
Belanoff said the company¿s burn rate was ¿very low,¿ but Corcept will be spending in greater amounts as the trials get up and running. How those trials turn out will determine Corcept¿s next financing move.
¿I think that, depending on our trials, we will be ready to come to the market, either the public or private market, in the next nine months to two years,¿ Belanoff said.
RU 486, or ¿the French abortion pill,¿ is available internationally and was approved in the United States by the FDA in September, amid the usual controversy surrounding abortion issues. However, Belanoff and the scientists at Corcept found that it works ¿by a totally different mechanism¿ to treat psychotic depression.
¿It works by blocking the glucocorticoid receptor, or GR, one of the receptors that accepts cortisol,¿ Belanoff explained. ¿The way it works to terminate pregnancy is to block the progesterone receptor. A million women have used it for that. It was discovered about 10 years after the drug was discovered that there are two receptors that accept cortisol. GR1 is for normal, everyday living. GR2 is only activated when cortisol levels are high. C-1073 only blocks GR2.¿ Cortisol is produced by the body in response to stress.
GR2 has one-tenth the affinity for cortisol as GR1, Belanoff said. High levels of cortisol aren¿t bad unless the level stays high ¿ as in the case of people with psychotic depression. The idea is that by blocking that high-level glucocorticoid receptor, psychotic major depression can be brought under control.
The drug showed positive results in a six-center Phase IIb trial. Now, with $27 million to fund it, Corcept is weeks away from initiating its Phase III trials. Belanoff said there will be two studies, both double-blinded, each to include about 200 patients. In one arm, the patients will be allowed to continue whatever medication they are currently on while being administered either C-1073 or placebo for seven days. The second arm will be similar, except patients will not be allowed to be on any other medication during the dosing period.
Efficacy will be measured at a week and then again at a month. The primary endpoint will be measured by the Brief Psychiatric Rating Scale, Belanoff said.
Corcept, of Menlo Park, Calif., received its seed funding in 1999 and raised $1.8 million before the Series C. It was founded by Belanoff, Alan Schatzberg and David Singer. Singer previously was CEO of Affymetrix Inc., of Santa Clara, Calif., and now is CEO of GeneSoft Inc., of South San Francisco. Corcept has about 11 employees now, including part-timers, and although Belanoff said the head count should always be relatively low at Corcept, he hopes it will grow to around 30 to 50 employees. With the financing and start of Phase III, things are changing in Menlo Park.
¿We are now shifting from a company that is proving a scientific concept to one that is marketing medication,¿ he said.
Still, the question remains: How and why has Corcept flown so low?
¿We basically wanted to make sure the drug worked before we told anyone,¿ Belanoff said. ¿And we wanted to have our Phase II studies done. Part of it is that our background is academic, where you don¿t put anything out there until you are absolutely sure. It¿s the opposite end ¿ a totally opposite place from business. We¿ve been cautious, but we¿ve had striking results up to this point.¿
The investors in the round were Sutter Hill Ventures, of Palo Alto, Calif.; Alta Partners, of San Francisco; and Maverick Capital, of Dallas.