Mid-Cap Corcept Therapeutics Reveals Data From Hormonal Disorder Study, FDA Application Submission Expected This Quarter
Mid-Cap Corcept Therapeutics Reveals Data From Hormonal Disorder Study, FDA Application Submission Expected This Quarter
Monday, Corcept Therapeutics Incorporated (NASDAQ:CORT) released results from the open-label portion of the pivotal Phase 3 GRACE trial of its proprietary selective cortisol modulator relacorilant in patients with all etiologies of endogenous Cushing's syndrome (hypercortisolism).
週一，Corcept Therapeutics Incorporated（納斯達克股票代碼：CORT）公佈了其專有的選擇性皮質醇調節劑緩和劑的關鍵性3期GRACE試驗的開放標籤部分的結果，該試驗適用於所有內源性庫欣綜合徵（皮質醇增多症）病因的患者。
GRACE has two parts.
GRACE 有兩個部分。
- In the "open-label" phase, 152 patients with Cushing's syndrome and either hypertension, hyperglycemia, or both received relacorilant for 22 weeks.
- Patients who exhibited pre-specified improvements in either or both symptoms could enter the trial's withdrawal phase.
- 在 “開放標籤” 階段，152名庫欣綜合徵患者以及高血壓、高血糖症或兩者兼而有之的患者接受了爲期22周的relacorilant治療。
- 預先規定的一種或兩種症狀都有改善的患者可以進入試驗的戒斷階段。
No cases of relacorilant-induced endometrial hypertrophy with or without vaginal bleeding were seen, nor were there any instances of adrenal insufficiency or QT prolongation.
沒有見到伴有或沒有****出血的 relacorilant 誘發的子宮內膜肥大病例，也沒有出現任何腎上腺功能不全或 QT 延長的病例。
Rapid and sustained improvements in systolic blood pressure (SBP) and diastolic blood pressure (DBP) were observed in all patients with hypertension, with an improvement in mean SBP of 7.9 mm Hg and mean DBP of 5.4 mm Hg at 22 weeks (p-values: <0.0001).
觀察到所有高血壓患者的收縮壓（SBP）和舒張壓（DBP）迅速持續改善，22周時平均SBP改善爲7.9 mm Hg，平均DBP爲5.4 mm Hg（p值：
During the open-label phase, 63% of patients with hypertension met the study's response criteria.
在開放標籤階段，63％的高血壓患者符合研究的反應標準。
For the patients that entered the randomized withdrawal phase, the observed improvements in hypertension were even greater, with improvements in mean SBP of 12.6 mm Hg and mean DBP of 8.3 mm Hg at 22 weeks (p-values: <0.0001).
對於進入隨機戒斷階段的患者，觀察到的高血壓改善幅度甚至更大，22周時的平均SBP改善爲12.6 mm Hg，平均DBP爲8.3 mm Hg（p值：
Clinically meaningful and statistically significant improvements in glucose metabolism were observed for all patients with hyperglycemia.
所有高血糖患者的葡萄糖代謝均有臨床意義且具有統計學意義的改善。
Data showed improvements in mean AUC glucose of 3.3 h*mmol/L, mean HbA1c of 0.3 percent, and mean fasting glucose of 12.4 mg/dL at 22 weeks (p-values: <0.0001, 0.03, 0.03, respectively).
數據顯示，22周時，AUC的平均血糖改善了3.3 h*mmol/L，平均血糖水平爲0.3％，空腹平均血糖爲12.4 mg/dL（p值：分別
During the open-label phase, 50% of patients with hyperglycemia met the study's response criteria.
在開放標籤階段，50％的高血糖患者符合研究的反應標準。
For the patients that entered the randomized withdrawal phase, the observed improvements in hyperglycemia were even greater, with improvements in mean AUCglucose of 6.2 h*mmol/L, mean HbA1c of 0.7 percent, and mean fasting glucose of 25.2 mg/dL at 22 weeks (p-values: <0.0001, <0.0001, 0.006, respectively).
對於進入隨機戒斷階段的患者，觀察到的高血糖改善幅度甚至更大，平均Aucglucose的改善幅度爲6.2 h*mmol/L，平均HbA1c爲0.7％，22周時的平均空腹血糖爲25.2 mg/dL（p值：分別
Relacorilant was well tolerated. The most common adverse events were mild-to-moderate nausea, edema, pain in extremities and back, and fatigue.
Relacorilant 的耐受性良好。最常見的不良事件是輕度至中度噁心、水腫、四肢和背部疼痛以及疲勞。
"We expect to build on these results in the trial's randomized withdrawal phase. We plan to present data from the open-label and randomized withdrawal phases at a medical conference in June and remain on track to submit our NDA this quarter," said Bill Guyer, Corcept's Chief Development Officer.
“我們希望在試驗的隨機撤回階段在這些結果的基礎上再接再厲。我們計劃在6月的醫學會議上公佈開放標籤和隨機戒斷階段的數據，並有望在本季度提交保密協議。” Corcept首席開發官比爾·蓋爾說。
Price Action: CORT shares are down 1.94% at $22.50 on the last check Monday.
價格走勢：在週一的最後一次支票中，CORT股價下跌1.94％，至22.50美元。
Illustration of Phrama lab worker created with MidJourney.
使用 MidJourney 創作的 Phrama 實驗室工作人員的插圖。
譯文內容由第三人軟體翻譯。