CORT Corcept Therapeutics Incorporated
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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Relacorilant plus Abraxane
Ovarian cancer
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Phase 2
Phase 2
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Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
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Relacorilant plus nab-paclitaxel (RELIANT)
Pancreatic cancer
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Phase 3
Phase 3
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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Miricorilant (GRATITUDE)
Antipsychotic-induced weight gain (APIWG)
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Phase 2
Phase 2
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Phase 2 trial enrolling.
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Miricorilant
Nonalcoholic steatohepatitis (NASH)
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Phase 2
Phase 2
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Phase 2 trial to be initiated November 2020.
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Relacorilant (GRACE)
Cushing’s syndrome
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Phase 3
Phase 3
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Phase 3 commencement of enrolment announced November 19, 2018. NDA planned for 2Q 2022.
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Exicorilant plus Enzalutamide
Castration-resistant prostate cancer (CRPC)
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Phase 1/2
Phase 1/2
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Selection of optimum dose expected 1Q 2021.
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Relacorilant plus Keytruda
Adrenocortical cancer
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Phase 1b
Phase 1b
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Phase 1b trial has been initiated.
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Miricorilant (GRATITUDE 2)
Long-standing antipsychotic-induced weight gain (APIWG)
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Phase 2
Phase 2
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Phase 2 trial initiated 3Q 2020.
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Relacorilant (GRADIENT)
Cushing’s syndrome
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Phase 3
Phase 3
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Phase 3 initiation announced July 28, 2020.
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Miricorilant
Healthy volunteers
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Phase 1b
Phase 1b
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Phase 1b 900 mg cohort data released May 4, 2020.
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Corlux - Korlym
Cushing's Syndrome
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Approved
Approved
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Approved February 17, 2012.
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Latest News
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MENLO PARK, Calif., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, announced today that Gillian M. Cannon, PhD, has joined the company's Board of Directors.
Dr. Cannon brings to Corcept more than 30 years experience in the pharmaceutical industry, where she has served in leadership roles at Merck and Co. Inc., UCB Inc. and Otsuka Pharmaceuticals. In her 27-year career at Merck, Dr. Cannon held a variety of senior positions, including Global Vice President for Commercial Operations at Merck's start-up biosimilar business, Merck BioVentures; Business Unit Head for Merck's specialty products franchise; and Global Commercial Head of its neuroscience franchise. She is currently President of Alyvant and Executive in Residence for Roivant Sciences.
"I am very pleased to welcome Gillian to our board," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "Her extensive experience in pharmaceutical commercial operations, marketing and sales and her track record of devising and gaining acceptance for innovative solutions will help us advance our pipeline of proprietary, selective cortisol modulators."
About Corcept Therapeutics
Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.
Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals and conduct our clinical trials during the Covid-19 pandemic and to generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym®; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates and oversight, and other requirements. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include statements regarding advancement of our pipeline of proprietary, selective cortisol modulators. We disclaim any intention or duty to update forward-looking statements made in this press release.
CONTACT:
Christopher S. James, MD
Director, Investor Relations
Corcept Therapeutics
650-684-8725
[email protected]
www.corcept.com
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MENLO PARK, Calif., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, announced today that the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office has issued a decision upholding the validity of all claims of U.S. Patent No. 10,195,214, "Concomitant Administration of Glucocorticoid Receptor Modulators and CYP3A Inhibitors" (the "‘214 patent"). The ‘214 patent expires in 2037.
"We are gratified by the PTAB's decision," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer. "The ‘214 patent is directed to an important medical discovery – that, with dose-adjustment as set forth in its FDA-approved label, Korlym® can be safely co-administered with medications known as strong CYP3A inhibitors, including commonly-prescribed antiviral, antibiotic, antifungal and antidepressant medications. Patients with Cushing's syndrome often experience significant co-morbidities. We are glad that our research has increased the array of medications available to the physicians who treat them."
Hypercortisolism
Hypercortisolism, often referred to as Cushing's syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing's syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing's syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system in the body and can be lethal if not treated effectively.
About Corcept Therapeutics
Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.
Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals and conduct our clinical trials during the Covid-19 pandemic and to generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates and oversight, and other requirements. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include statements regarding the scope of the company's intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.
CONTACT:
Christopher S. James, MD
Director, Investor Relations
Corcept Therapeutics
650-684-8725
[email protected]
www.corcept.com -
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MENLO PARK, Calif., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, today reported its results for the quarter ended September 30, 2020.
Financial Highlights
- Revenue of $86.3 million, a 6 percent increase from third quarter 2019
- GAAP diluted net income of $0.17 per share, compared to $0.22 per share in third quarter 2019
- Non-GAAP diluted net income of $0.24 per share, compared to $0.31 per share in third quarter 2019
- Cash and investments of $444.2 million, compared to $409.6 million at June 30, 2020
- Announcement of $200 million stock repurchase program
- 2020 revenue guidance narrowed to $355 – 365 million
Revenue was $86.3 million in the third quarter, compared to $81.5 million in the third quarter of 2019. Third quarter GAAP net income was $21.6 million, compared to $26.3 million in the same period last year. Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in the third quarter was $30.0 million, compared to $37.8 million in the third quarter of 2019. A reconciliation of GAAP to non-GAAP net income is included below.
Corcept narrowed its 2020 revenue guidance range to $355 – 365 million. The company's initial guidance, announced in January 2020, was $355 – 375 million.
Third quarter operating expenses were $61.6 million, compared to $48.5 million in the third quarter of 2019, primarily due to increased spending on clinical trials in Cushing's syndrome, antipsychotic-induced weight gain and solid tumors, and on the formulation and manufacture the company's proprietary selective cortisol modulators.
Cash and investments were $444.2 million at September 30, 2020, an increase of $34.7 million from June 30, 2020.
The company announced a program to repurchase up to $200 million of its common stock, funded using cash and investments. Details of the program are provided below.
"While pandemic-related public health restrictions and related changes in physician and patient practices dampened our third quarter commercial results," said Joseph K. Belanoff, MD, Corcept's Chief Executive Officer, "we have built a remarkably stable and profitable business. After Covid-19 is brought under control, we expect our growth to resume.
"Meanwhile, the breadth of our clinical development program continues to increase. We are now evaluating our proprietary, selective cortisol modulators in patients with Cushing's syndrome, four different types of solid tumors, antipsychotic-induced weight gain (APIWG) and – starting this month – nonalcoholic steatohepatitis (NASH). The pandemic's effect on these trials has varied," added Dr. Belanoff. "Studies of illnesses which are acutely life-threatening, including advanced ovarian and pancreatic cancer have recruited briskly. Studies of illnesses that are not perceived as immediately dire – such as antipsychotic-induced weight gain – have lagged."
Cushing's Syndrome
- Phase 3 GRACE trial of relacorilant in patients with any etiology of Cushing's syndrome continues at sites in the United States, Canada, Europe and Israel; NDA submission planned for second quarter 2022
- Enrollment begun in Phase 3 GRADIENT trial of relacorilant in patients with Cushing's syndrome of adrenal origin continues, with sites planned in the United States, Europe and Israel
"We are evaluating our proprietary selective cortisol modulator relacorilant as a treatment for Cushing's syndrome in two double-blind, placebo-controlled Phase 3 trials," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "GRACE has a planned enrollment of 130 patients with any type of Cushing's syndrome. GRADIENT has a planned enrollment of 130 patients with Cushing's syndrome caused by adrenal adenomas – an etiology of hypercortisolism where medical treatment has not been rigorously studied. While recruitment in both trials has slowed due to the pandemic, our investigators are enthusiastic. We plan to submit an NDA based on results from the GRACE trial in the second quarter of 2022."
Solid Tumors
- Enrollment complete in 178-patient, controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with metastatic ovarian cancer; results expected in first half 2021
- Enrollment continues in 80-patient, open-label Phase 3 RELIANT trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer; results in first 40 patients expected in first half 2021
- Selection of optimum dose of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer expected in first quarter 2021
- Initiation of 20-patient, open-label, Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab in patients with adrenal cancer with cortisol excess
"Our oncology program is evaluating three mechanisms by which cortisol modulators may benefit patients with solid tumors," said Dr. Grauer. "Our Phase 2 trial in patients with metastatic ovarian cancer and our Phase 3 trial in patients with metastatic pancreatic cancer are evaluating whether relacorilant can enhance the efficacy of nab-paclitaxel by reducing cortisol's suppression of apoptosis – the programmed cell death chemotherapy is meant to promote. We expect results from both of these trials in the first half of next year.
"In the first quarter of 2021, we expect to select a dosing regimen for our selective cortisol modulator exicorilant to advance as a treatment for castration-resistant prostate cancer. Androgen deprivation therapy is the standard treatment for this disease. However, with time, many tumors treated with androgen deprivation therapy switch to cortisol stimulation as the pathway to growth. Our hypothesis, which is well-supported in pre-clinical models, is that a regimen that combines an androgen receptor antagonist such as enzalutamide with a cortisol modulator will close off this tumor escape route.
"Finally, our recently initiated Phase 1b trial of relacorilant combined with pembrolizumab is testing whether co-administrating a cortisol modulator can help immunotherapy achieve its intended effect by reducing cortisol-activated immune suppression."
Metabolic Diseases
- Enrollment begun in GRATITUDE II, a 150-patient, double-blind, placebo-controlled Phase 2 trial of miricorilant to reverse long-standing APIWG
- Enrollment continues in GRATITUDE, a double-blind, placebo-controlled, Phase 2 trial of miricorilant to reverse recent APIWG
- Double-blind, placebo-controlled Phase 2 trial of miricorilant in patients with NASH starting this month
"In the third quarter, we opened GRATITUDE II, the second Phase 2 trial of our selective cortisol modulator miricorilant in patients with antipsychotic-induced weight gain – a life-threatening disorder experienced by many of the millions of patients who take antipsychotic medications," said Dr. Grauer. "GRATITUDE II is enrolling patients with long-standing weight gain. Its sister trial, GRATITUDE is enrolling patients with recent weight gain.
"These trials follow promising pre-clinical and clinical data. For example, in the Phase 1b trial we completed earlier this year, healthy volunteers given miricorilant plus olanzapine gained less weight and had lower triglycerides and less sharply elevated liver enzymes than those who received olanzapine plus placebo after only two weeks of dosing.
"Finally, we plan to begin evaluating miricorilant as a potential treatment for liver disease. Extensive pre-clinical data suggests miricorilant may benefit patients with NASH, a serious liver disorder that affects millions of patients," added Dr. Grauer. "We are on-track to open a double-blind, placebo-controlled trial of miricorilant in patients with NASH by year-end."
Conference Call
We will hold a conference call on November 3, 2020, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, click this link 15 minutes prior to the scheduled start time or dial 1-888-204-4368 from the United States or 1-313-209-4906 internationally (passcode 9018217). A replay will be available through November 17, 2020 at 1-888-203-1112 in the United States and 1-719-457-0820 internationally
(passcode 9018217).About Corcept's Stock Repurchase Program
Our Board of Directors has approved a program authorizing the repurchase of up to $200 million of the company's common stock through September 30, 2021. Purchases under this program may be made in the open market, in privately negotiated transactions or otherwise. The timing and amount of any repurchases will be determined based on market conditions, stock price and other factors. The program does not require the company to repurchase any specific number of shares of its common stock and may be modified, suspended or discontinued at any time without notice.
About Corcept Therapeutics
Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.
GAAP Measures of Net Income
To supplement our financial results presented on a GAAP basis, we use non-GAAP measures of net income, basic net income per share and diluted net income per share that exclude the following non-cash expenses – (i) stock-based compensation, (ii) our use of deferred tax assets to offset current tax expense and (iii) related income tax effects. We believe these non-GAAP measures help investors evaluate our financial performance and potential future results. Our non-GAAP measures may be different from, and not directly comparable to, those used by other companies. They are not a substitute for comparable GAAP measures and should not be considered in isolation. Investors should read our non-GAAP presentation in conjunction with our financial statements prepared in accordance with GAAP.
Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals and conduct our clinical trials during the Covid-19 pandemic and to generate sufficient revenue to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates and oversight, and other requirements. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include those concerning our 2020 revenue guidance; our stock repurchase program and its intended funding sources; the impact of the Covid-19 pandemic on our operations, financial performance and clinical development programs; expectations regarding our sales levels after Covid-19 is brought under control; the progress, enrollment, timing, design and results of our clinical trials; and the clinical and commercial attributes of relacorilant, exicorilant and miricorilant. We disclaim any intention or duty to update forward-looking statements made in this press release.
CORCEPT THERAPEUTICS INCORPORATED
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)September 30,
2020December 31,
2019 (1)(Unaudited) Assets Cash and investments $ 444,218 $ 315,314 Trade receivables, net of allowances 21,957 19,928 Inventory 16,892 17,405 Operating lease right-of-use asset 2,993 3,446 Deferred tax assets, net 33,818 45,677 Other assets 14,247 10,542 Total assets $ 534,125 $ 412,312 Liabilities and Stockholders' Equity Accounts payable $ 6,510 $ 7,537 Operating lease liabilities 3,031 3,461 Other liabilities 34,904 30,132 Stockholders' equity 489,680 371,182 Total liabilities and stockholders' equity $ 534,125 $ 412,312 (1) Derived from audited financial statements at that date
CORCEPT THERAPEUTICS INCORPORATEDCONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(In thousands, except per share data)Three Months Ended
September 30,Nine Months Ended
September 30,2020 2019 2020 2019 Revenues Product revenue, net $ 86,327 $ 81,505 $ 268,139 $ 218,591 Operating expenses Cost of sales 1,216 1,451 4,328 4,068 Research and development 33,869 22,805 86,489 64,705 Selling, general and administrative 26,523 24,245 79,630 73,228 Total operating expenses $ 61,608 $ 48,501 $ 170,447 $ 142,001 Income from operations 24,719 33,004 97,692 76,590 Interest and other income 622 1,348 3,103 3,626 Income before income taxes 25,341 34,352 100,795 80,216 Income tax expense (3,716 ) (8,012 ) (20,778 ) (15,416 ) Net income $ 21,625 $ 26,340 $ 80,017 $ 64,800 Other comprehensive
income (loss):Net unrealized gain on available-for-sale investments, net of tax impact of $109, $1, $(81) and $(123), respectively (347 ) (2 ) 259 389 Foreign currency translation loss, net of tax 84 (5 ) 57 (5 ) Total comprehensive income $ 21,362 $ 26,333 $ 80,333 $ 65,184 Basic net income per share $ 0.19 $ 0.23 $ 0.70 $ 0.57 Diluted net income per share $ 0.17 $ 0.22 $ 0.65 $ 0.53 Shares used in computing basic net income per common share 115,734 113,875 115,107 114,349 Shares used in computing diluted net income per common share 124,464 121,762 123,337 122,478 CORCEPT THERAPEUTICS INCORPORATED
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME
(In thousands, except per share data)Three Months Ended
September 30,Nine Months Ended
September 30,2020 2019 2020 2019 GAAP net income $ 21,625 $ 26,340 $ 80,017 $ 64,800 Non-cash expenses (benefits) Stock-based compensation Cost of sales 13 22 51 105 Research and development 2,958 2,350 8,357 6,834 Selling, general and administrative 5,731 4,899 16,701 14,764 Total stock-based compensation 8,702 7,271 25,109 21,703 Deferred income taxes 1,761 5,897 11,778 11,731 Income tax effect of non-GAAP adjustments (1) (2,088 ) (1,745 ) (6,026 ) (5,209 ) Non-GAAP net income, adjusted for non-cash expenses $ 30,000 $ 37,763 $ 110,878 $ 93,025 GAAP basic net income
per share$ 0.19 $ 0.23 $ 0.70 $ 0.57 GAAP diluted net income
per share$ 0.17 $ 0.22 $ 0.65 $ 0.53 Non-GAAP basic net income per share, adjusted for
non-cash expenses per share$ 0.26 $ 0.33 $ 0.96 $ 0.81 Non-GAAP diluted net income per share, adjusted for
non-cash expenses per share$ 0.24 $ 0.31 $ 0.90 $ 0.76 Shares used in computing basic net income per common share 115,734 113,875 115,107 114,349 Shares used in computing diluted net income per common share 124,464 121,762 123,337 122,478 (1) Calculated by applying the statutory tax rate to the pre-tax, non-discrete, non-GAAP adjustments. CONTACT:
Christopher S. James, MD
Director, Investor Relations
Corcept Therapeutics
650-684-8725
[email protected]
www.corcept.com -
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MENLO PARK, Calif., Oct. 27, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT) today announced it will report third quarter financial results and provide a corporate update on November 3, 2020. The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).
Conference Call Information
To participate, click the link below and enter your information. The link will become active 15 minutes prior to the scheduled start time.Alternatively, you may dial 1-888-204-4368 from the United States or 1-313-209-4906 internationally approximately 15 minutes before the start of the call. The passcode will be 9018217.
A replay will be available through November 17, 2020 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 9018217.
About Corcept Therapeutics Incorporated
Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.
CONTACT:
Christopher S. James, MD
Director, Investor Relations
Corcept Therapeutics
650-684-8725
[email protected]
www.corcept.com -
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MENLO PARK, Calif., Sept. 10, 2020 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, today announced enrollment of its first patient in GRATITUDE II, a randomized, double-blind, placebo-controlled, Phase 2 trial of miricorilant in obese patients with schizophrenia and long-standing antipsychotic-induced weight gain (APIWG).
GRATITUDE II has a planned enrollment of 150 patients, who will continue to receive their established dose of antipsychotic medication, plus either 600 milligrams of miricorilant, 900 milligrams of miricorilant or placebo, for 26 weeks. The primary endpoint is reduction in bodyweight. GRATITUDE II will be conducted at 35 centers in the United States.
GRATITUDE I, Corcept's first Phase 2 trial of miricorilant in APIWG, continues to enroll patients with schizophrenia and recent weight gain. Patients in GRATITUDE I receive, in addition to their established antipsychotic regimen, either 600 milligrams of miricorilant or placebo for 12 weeks. The primary endpoint is change in bodyweight.
"Substantial, sustained weight gain and associated metabolic co-morbidities shorten the lives of many of the millions of patients who take antipsychotic medications and significantly reduce quality of life for many more," said Andreas Grauer, MD, Corcept's Chief Medical Officer. "Miricorilant has demonstrated promise as a potential treatment for this disorder.1 In our double-blind, placebo-controlled, Phase 1b trial, after just two weeks of treatment, healthy subjects given miricorilant in addition to olanzapine gained significantly less weight than subjects who received olanzapine plus placebo. Patients receiving miricorilant also experienced smaller increases in the enzymes AST and ALT, which suggests miricorilant may help protect the liver. We hope to confirm and extend our Phase 1b results in GRATITUDE II, which is using an improved formulation of miricorilant and a longer treatment duration."
About Corcept Therapeutics
Corcept is a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the hormone cortisol. Korlym® was the first drug approved by the U.S. Food and Drug Administration for patients with Cushing's syndrome. Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol. The company owns extensive United States and foreign intellectual property covering the composition of its selective cortisol modulators and the use of cortisol modulators to treat a variety of serious disorders.
CONTACT:
Christopher S. James, MD
Director, Investor Relations
Corcept Therapeutics
650-684-8725
[email protected]
www.corcept.com1 For data from our studies in animal models of APIWG, see our 2020 American Psychiatry Association (APA) poster at the Research & Pipeline / Publications tab of our website.