Corcept's Lead Drug Korlym Aids Growth, Heavy Reliance a Woe

On Sep 16, we issued an updated research report on Corcept Therapeutics Incorporated CORT.

Corcept’s only marketed drug Korlym is approved for the once-daily oral treatment of hyperglycemia — secondary to hypercortisolism — in adult patients with endogenous Cushing’s syndrome who are suffering type II diabetes or glucose intolerance and who already failed surgery or are unsuitable for surgery.

Notably, Corcept’s lead candidate relacorilant is being evaluated in the phase III GRACE study to treat Cushing’s syndrome. Dosing is currently underway in the above-mentioned study at sites across the United States, Israel and Europe. The company plans to submit a new drug application (NDA) for relacorilant in the second quarter of 2022. Meanwhile, enrollment is ongoing in the phase III study of GRADIENT on relacorilant in patients whose Cushing’s syndrome is caused by adrenal adenoma.

Corcept completed its enrollment in a phase II study on relacorilant plus Celgene's [now part of Bristol Myers BMY] Abraxane (nab-paclitaxel) to treat metastatic ovarian cancer and is on track to generate results in first-half 2021.

In July 2020, Corcept recruited the first patient in the phase III RELIANT study, evaluating relacorilant in combination with Abraxane for the treatment of patients with metastatic pancreatic cancer. The company also expects to begin a phase Ib study shortly on relacorilant plus Merck’s MRK PD-1 checkpoint inhibitor Keytruda (pembrolizumab) to treat patients with metastatic or unresectable adrenal cancer.

Apart from relacorilant, Corcept’s other pipeline camdidates include exicorilant and miricorilant, which are also progressing well.

Corcept is advancing exicorilant as a treatment for patients with metastatic castration-resistant prostate cancer (CRPC). Earlier this month, Corcept began recruitment in the phase II GRATITUDE 2 study on miricorilant in obese patients with schizophrenia and long-standing APIWG. Approval of these candidates is key to long-term growth at Corcept

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. A decline in its sales will significantly hurt the company’s prospects. Moreover, the medicine faces stiff competition from Signifor, which is approved for the treatment of adult patients with Cushing’s disease for whom, surgery failed. Notably, in July 2019, Novartis NVS sold the worldwide rights to Signifor to the Italian pharmaceutical company Ricordati S.p.A.

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