Corcept Therapeutics Incorporated's ( CORT Quick Quote CORT - Free Report) only marketed drug, Korlym, has been approved for the once-daily oral treatment of hyperglycemia — secondary to hypercortisolism — in adult patients with endogenous Cushing’s syndrome who are suffering from type II diabetes or glucose intolerance, and who have already failed surgery or are unsuitable for the same.
The company’s top line solely comprises of Korlym sales which witnessed a year-over-year decline during the first quarter of 2021 due to adverse effects of the COVID-19 pandemic.
Notably, Corcept’s lead pipeline candidate, relacorilant, is being evaluated in the phase III GRACE study to treat Cushing’s syndrome. Enrollment is currently underway in the above-mentioned study at sites across the United States, Canada, Europe and Israel. A new drug application for relacorilant is expected to be submitted in the second quarter of 2023.
Relacorilant is also being examined in phase III of the GRADIENT study in patients whose Cushing’s syndrome is caused by adrenal adenoma. Enrollment in this study is underway
Additionally, Corcept has completed enrollment in a phase II study on relacorilant in combination with
Bristol Myers’ ( BMY Quick Quote BMY - Free Report) Abraxane for the treatment of metastatic ovarian cancer. Last week the company announced data from this study which showed that women who were treated with relacorilant plus Abraxane experienced improved progression-free survival as compared to those who received Abraxane alone.
The combo of relacorilant plus Abraxane is also being evaluated in the phase III RELIANT study for addressing patients with metastatic pancreatic cancer. Meanwhile, in March 2021, Corcept enrolled the first patient in the phase Ib study evaluating relacorilant in combination with
Merck’s ( MRK Quick Quote MRK - Free Report) PD-1 checkpoint inhibitor, Keytruda, for the treatment of patients suffering from adrenal cancer with cortisol excess.
Corcept’s other pipeline candidates include exicorilant and miricorilant, which are also progressing well.
The company is conducting an open-label dose-finding study on exicorilant in combination with
Pfizer’s ( PFE Quick Quote PFE - Free Report) Xtandi for treating patients with metastatic castration-resistant prostate cancer.
Meanwhile, last week, the company announced data from a phase II study evaluating miricorilant as a potential treatment of nonalcoholic steatohepatitis (“NASH”), a serious liver disease. Data from the same showed that patients with presumed NASH who were administered miricorilant experienced large, rapid reductions in liver fat.
Successful development and potential approval of all these candidates will lend a big boost to Corcept, given the lucrative market that it targets.
Notably, Korlym has been performing well since its launch and has seen a strong uptake. Corcept is currently working on developing the drug for more indications. However, the company is solely dependent on Korlym for growth. Moreover, its pipeline is still some years away from commercialization. Hence, a decline in Korlym sales will significantly hurt the company’s prospects.
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