BioCryst To Start Pivotal BCX9930 Trial In Rare Blood Disorder In 2H'21
BioCryst To Start Pivotal BCX9930 Trial In Rare Blood Disorder In 2H'21
BioCryst公司將於21年下半年開始BCX9930治療罕見血液病的關鍵試驗
BioCryst Pharmaceuticals Inc (NASDAQ: BCRX) announced results from a dose-ranging trial evaluating BCX9930 in treatment-naïve paroxysmal nocturnal hemoglobinuria (PNH) patients and PNH patients with an inadequate response to C5 inhibitors.
- The results showed that BCX9930 significantly increased hemoglobin and reduced transfusions, was safe and generally well-tolerated in the trial.
- Based on these results, the company plans to advance directly into pivotal trials in PNH and proof of concept trials in renal complement-mediated diseases in the second half of 2021.
- PNH patients in the trial also experienced reductions in key laboratory biomarkers such as reticulocyte count, lactate dehydrogenase (treatment-naïve patients), and percentage of C3 opsonization (patients with inadequate C5 response) following dosing at 400 mg bid or 500 mg bid.
- Hemoglobin levels increased by a mean of 3.5 g/dL in treatment-naïve patients and 3.2 g/dL in C5 inhibitor inadequate response patients; at the last visit, mean hemoglobin levels were 11.8 g/dL and 12.2 g/dL, respectively.
- Relative red blood cell clone size, a marker of hemolytic control, also increased from 53% to 92% in treatment-naïve patients and from 50% to 80% in C5 inhibitor inadequate response patients.
- There were no discontinuations or drug interruptions due to related adverse events. No safety signals were observed.
- Price Action: BCRX shares are trading 2.04% higher at $13.51 in premarket trading on the last check Monday.
BioCryst Pharmaceuticals Inc (NASDAQ: BCRX) announced results from a dose-ranging trial evaluating BCX9930 in treatment-naïve paroxysmal nocturnal hemoglobinuria (PNH) patients and PNH patients with an inadequate response to C5 inhibitors.
BioCryst製藥公司(納斯達克:BCRX) 宣佈了一項劑量範圍試驗的結果評估BCX9930在治療幼稚陣發性睡眠性血紅蛋白尿(PNH)患者和對C5抑制劑反應不足的PNH患者中的作用。
- The results showed that BCX9930 significantly increased hemoglobin and reduced transfusions, was safe and generally well-tolerated in the trial.
- Based on these results, the company plans to advance directly into pivotal trials in PNH and proof of concept trials in renal complement-mediated diseases in the second half of 2021.
- PNH patients in the trial also experienced reductions in key laboratory biomarkers such as reticulocyte count, lactate dehydrogenase (treatment-naïve patients), and percentage of C3 opsonization (patients with inadequate C5 response) following dosing at 400 mg bid or 500 mg bid.
- Hemoglobin levels increased by a mean of 3.5 g/dL in treatment-naïve patients and 3.2 g/dL in C5 inhibitor inadequate response patients; at the last visit, mean hemoglobin levels were 11.8 g/dL and 12.2 g/dL, respectively.
- Relative red blood cell clone size, a marker of hemolytic control, also increased from 53% to 92% in treatment-naïve patients and from 50% to 80% in C5 inhibitor inadequate response patients.
- There were no discontinuations or drug interruptions due to related adverse events. No safety signals were observed.
- Price Action: BCRX shares are trading 2.04% higher at $13.51 in premarket trading on the last check Monday.
- 結果表明,BCX9930在試驗中顯著增加血紅蛋白,減少輸血,是安全的,總體耐受性良好。
- 基於這些結果,該公司計劃在2021年下半年直接進入PNH的關鍵試驗和腎臟補體介導的疾病的概念驗證試驗。
- 試驗中的PNH患者在服用400毫克BID或500毫克BID後,還經歷了關鍵實驗室生物標記物的減少,如網織紅細胞計數、乳酸脱氫酶(未接受治療的患者)和C3調理百分比(C5反應不充分的患者)。
- 初治患者血紅蛋白水平平均升高3.5g/dL,補體C5抑制劑療效不佳患者平均升高3.2g/dL,上次就診時,平均血紅蛋白水平分別為11.8g/dL和12.2g/dL。
- 溶血控制的標誌--相對紅細胞克隆大小,在初治患者中也從53%增加到92%,在C5抑制劑反應不足的患者中從50%增加到80%。
- 沒有因相關不良事件而中斷或停藥的病例。沒有觀察到安全信號。
- 價格行動:在週一的盤前交易中,BCRX的股價上漲了2.04%,至13.51美元。
譯文內容由第三人軟體翻譯。
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