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Celgene公布肾脏药sotatercept IIa期研究详细积极数据

来源:生物谷 2014-04-24 08:54

2014年4月24日讯 /生物谷BIOON/ --生物制药公司Acceleron 4月23日宣布,合作伙伴新基(Celgene)已公布实验性肾脏病药物sotatercept一项正在开展的IIa期研究的详细中期数据,并已提交至4月23日在美国内达华州举行的国家肾脏基金会2014春季临床会议。

该IIa期临床试验是一项随机、安慰剂对照、单剂量和多剂量、剂量递增研究,在正接受血液透析治疗的终末期肾脏病(ESRD)患者中开展,旨在评估sotatercept用于纠正(correction)ESRD患者贫血(anemia)的药代动力学、安全性、疗效、耐受性和药效动力学。首个剂量组调查0.1mg/kg剂量的sotatercept皮下给药,后续剂量组调查0.3mg/kg、0.5mg/kg、0.7mg/kg剂量sotatercept皮下给药,研究中每4周给药一次,持续治疗8个周期,主要终点是药代动力学和安全性,次要终点包括血红蛋白和血清标志物对骨代谢的影响。

IIa研究中2个低剂量组(0.3mg/kg、0.5mg/kg)的数据要点总结如下:

——单次给药后,在首个28天周期中,安慰剂组、sotatercept 0.3mg/kg剂量组、0.5mg/kg剂量组,分别有20%、37%、40%患者血红蛋白增加≥1.0g/升;

——安慰剂组、sotatercept 0.3mg/kg剂量组、0.5mg/kg剂量组,观察到的血红蛋白增加平均峰值分别为0.1克/升、0.5克/升、0.8克/升;

——安慰剂组、sotatercept 0.3mg/kg剂量组、0.5mg/kg剂量组,分别有40%、13%、0%患者需进行促红细胞生成素(erythropoietin)抢救疗法(血红蛋白水平下降至低于9g/升时)。

在2013年12月,Celgene启动了sotatercept用于治疗终末期肾脏病(ESRD)的第2个II期临床试验。该II期试验是一项2部分研究,旨在评估sotatercept治疗贫血和潜在控制慢性肾脏病矿物质和骨代谢异常(CKD-MBD)不良现象的安全性和疗效。

Acceleron公司目前有三个药物正处在II期临床开发--sotatercept,ACE-536 和 dalantercept。其中前2种药物都是与Celgene公司合作开发用于治疗地中海贫血和骨髓异常增生综合征,dalantercept则开发用于抑制肿瘤中的血管增生。

关于Sotatercept

Sotatercept是一种活化素(activin)受体IIA型融合蛋白,作为转化生长因子β(TGF-β)家族成员的一种配体陷阱(ligand trap)发挥作用。TGF-β家族成员参与红细胞生成(erythropoiesis)。Sotatercept调节晚期红细胞前体细胞的分化和成熟,其独特作用机制与促红细胞生成素(EPO)截然不同,EPO刺激早期红细胞前体细胞的分化。

目前,新基(Celgene)和Acceleron制药正在联合开发sotatercept,该药正处于多个II期临床试验。(生物谷Bioon.com)

英文原文:Acceleron and Celgene Announce Interim Clinical Data for Sotatercept Demonstrating Dose Dependent Increases in Hemoglobin in Patients with End Stage Renal Disease on Hemodialysis

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases, today announced that its collaboration partner, Celgene Corporation, presented interim data demonstrating dose dependent increases in hemoglobin in patients with end stage renal disease (ESRD) on hemodialysis. The data are from an ongoing phase 2a study of sotatercept and were presented at the National Kidney Foundation 2014 Spring Clinical Meeting in Las Vegas, NV.

The phase 2a clinical trial of sotatercept is designed as a randomized, placebo-controlled, dose escalation study to evaluate sotatercept for the correction of anemia in patients with end stage renal disease on hemodialysis. There are four sotatercept dose groups (0.3 mg/kg, 0.5 mg/kg, 0.7 mg/kg, or 0.7 mg/kg loading dose followed by 0.4 mg/kg). Highlights of the data from the two lowest dose level cohorts (0.3 mg/kg and 0.5 mg/kg) are summarized below:

—Hemoglobin increase ≥1.0 g/dL was achieved by 20%, 37% and 40% of patients in the placebo, sotatercept 0.3 mg/kg and sotatercept 0.5 mg/kg cohorts, respectively, in the first 28-day cycle following a single dose.

—The mean peak hemoglobin increase in the first 28-day dose cycle was 0.1 g/dL, 0.5 g/dL and 0.8 g/dL in patients in the placebo, sotatercept 0.3 mg/kg and sotatercept 0.5 mg/kg cohorts, respectively.

—Rescue therapy with erythropoietin, if hemoglobin levels fell to less than 9 g/dL, was required in 40% of placebo patients, 13% of patients at sotatercept 0.3 mg/kg, and 0% of patients at sotatercept 0.5 mg/kg.

About Sotatercept Clinical Trials in Patients with End Stage Renal Disease

The Phase 2a clinical trial of sotatercept is designed as a randomized, placebo-controlled single dose and multi-dose, dose escalation study to evaluate the pharmacokinetics, safety, efficacy, tolerability and pharmacodynamics of sotatercept for the correction of anemia in patients with end stage renal disease on hemodialysis. Eligible subjects are randomized to one of two arms (sotatercept or placebo in a 3:1 ratio) in 4 sequential dose groups (sotatercept 0.3 mg/kg, 0.5 mg/kg, 0.7 mg/kg, or 0.7 mg/kg loading dose followed by 0.4 mg/kg). Each dose group will include up to 12 patients. For additional information on this clinical trial, please visit www.clinicaltrials.gov, identifier NCT01146574.

In December, 2013, Celgene initiated a phase 2b clinical trial of sotatercept in patients with end stage renal disease (ESRD) who are on hemodialysis. This phase 2 clinical trial is designed as a two-part study to assess the safety and efficacy of sotatercept as a therapy to treat anemia and potentially to control the adverse manifestations of chronic kidney disease mineral and bone disorder (CKD-MBD). Part one of the study will enroll up to 60 patients and part two of the study will enroll up to 230 patients. For additional information on this clinical trial, please visit www.clinicaltrials.gov, identifier NCT01999582.

About Chronic Kidney Disease

Chronic Kidney Disease (CKD) is a serious condition characterized by the progressive loss of kidney function and is most often caused by diabetes or high blood pressure. CKD is classified in five stages according to the degree of kidney impairment. End Stage Renal Disease (ESRD), also known as kidney failure, is the most advanced stage of CKD and a life-threatening condition in which patients require a either kidney transplant or dialysis for survival. Anemia, low levels of red blood cells, is a common secondary disorder to Chronic Kidney Disease and worsens with progression of the disease. Disturbance in mineral and bone metabolism, known as Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD), is also a common complication in CKD patients that affects almost all patients who are on dialysis. CKD-MBD can lead to bone abnormalities and/or calcification in soft tissue, especially blood vessels, and is associated with increased morbidity and mortality in CKD patients.

About Sotatercept

Sotatercept is an activin receptor type IIA fusion protein that acts as a ligand trap for members in the Transforming Growth Factor-Beta (TGF-β) superfamily involved in the late stages of erythropoiesis (red blood cell production). Sotatercept regulates late-stage erythrocyte (red blood cell) precursor cell differentiation and maturation. This mechanism of action is distinct from that of erythropoietin (EPO), which stimulates the proliferation of early-stage erythrocyte precursor cells. Acceleron and Celgene are jointly developing sotatercept as part of a global collaboration. Sotatercept is currently in multiple phase 2 clinical trials.

About Acceleron

Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases. The company is a leader in understanding the biology of the Transforming Growth Factor-Beta (TGF-β) protein superfamily, a large and diverse group of molecules that are key regulators in the growth and repair of tissues throughout the human body, and in targeting these pathways to develop important new medicines. Acceleron has built a highly productive R&D platform that has generated innovative clinical and preclinical protein therapeutic candidates with novel mechanisms of action. These protein therapeutic candidates have the potential to significantly improve clinical outcomes for patients with cancer and rare diseases.

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