MENLO PARK, CA – Corcept Therapeutics (NASDAQ:) Incorporated (NASDAQ: CORT), a company specializing in the development of therapies for serious metabolic, oncology and endocrinology disorders, today disclosed positive results from the open-label Phase 3 GRACE trial. The trial is evaluating relacorilant, a selective cortisol modulator, for patients with endogenous Cushing's syndrome.
During the open-label phase, 152 patients with either hypertension, hyperglycemia, or both were treated with tonic for 22 weeks. Results showed significant improvements in blood pressure and glucose metabolism, with 63% of hypertensive and 50% of hyperglycemic patients meeting the study's response criteria.
In detail, the trial saw a reduction in mean systolic blood pressure of 7.9 mm Hg and diastolic blood pressure of 5.4 mm Hg. For glucose metabolism, there was a decrease in mean hemoglobin A1C of 0.3 percent and fasting glucose of 12.4 mg/dL. These results were considered clinically significant and statistically significant, with p values less than 0.05.
Patients who showed definite improvements could enter the double-blind withdrawal phase, where they either continued the reconstitution therapy or received placebo. The primary endpoint of this next phase is maintenance of blood pressure control, with a key secondary endpoint being glycemic control.
The safety profile of Relacorilant was consistent with previous findings, showing good tolerability and no major drug-related adverse events, including cases of endometrial hypertrophy, adrenal insufficiency, or QT prolongation.
Richard Auchus, MD, PhD, expressed that the drug's unique mechanism of action could make relacorilant a new standard of care for Cushing's syndrome, given the remarkable improvements seen in various symptoms without a significant safety burden.
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Corcept plans to present complete data from both the open-label and randomized withdrawal phases at a medical conference in June and aims to submit a New Drug Application (NDA) within this quarter.
The information in this article is based on a press release statement from Corcept Therapeutics.
InvestingPro Insights
As Corcept Therapeutics (NASDAQ: CORT ) continues to make progress in its clinical trials, the company's financial health remains a key factor for investors. Corcept's management has been proactive in enhancing shareholder value, as evidenced by its aggressive share repurchase strategy, which is an InvestingPro tip that underscores the company's leadership's confidence in its future prospects.
Additionally, Corcept has a stronger liquidity position, with more cash than debt on its balance sheet and liquid assets exceeding current liabilities. This financial stability is crucial as the company navigates the costly process of drug development and regulatory approvals.
In terms of valuation, Corcept's Market Cap is around $2.38B, with a Price-to-Earnings (P/E) ratio of 24.41 and an adjusted trailing-twelve-month P/E ratio from 2023Q4 to 22 ,59.
While the company trades at a high P/E ratio relative to near-term earnings growth, it's important to note that analysts predict the company will be profitable this year, a positive sign for potential investors. This profitability is further supported by a high Gross Profit Margin of 98.66% for the trailing twelve months from 2023Q4.
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