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Celgene公布肾脏药sotatercept积极中期数据

来源:生物谷 2014-03-18 07:03

2014年3月17日讯 /生物谷BIOON/ --生物技术公司Acceleron和合作伙伴新基(Celgene)公布了实验性肾脏病药物sotatercept一项正在开展的IIa期研究的中期数据。

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。

公布的数据来自于sotatercept 2个剂量(0.3mg/kg和0.5mg/kg)在首个28天给药周期中相对于安慰剂的安全性、药代动力学和血红蛋白数据。数据表明,单次给药后,安慰剂组、sotatercept 0.3mg/kg剂量组、0.5mg/kg剂量组,在首个28天周期中观察到的血红蛋白变化峰值分别为0.1克/升、0.5克/升、0.8克/升。不良反应多为轻至中度,与sotatercept无关,并于患者病史基本一致。研究中,未观察到剂量依赖的血压变化。

该项中期分析的详细数据将提交至4月22-26日在内达华州举行的国家肾脏基金会2014春季临床会议。

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

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, will present interim data from an ongoing phase 2a study of sotatercept in patients with end stage renal disease (ESRD) on hemodialysis at the National Kidney Foundation 2014 Spring Clinical Meeting. The meeting will take place on April 22-26, 2014 at the MGM Grand in Las Vegas, NV.

The data to be presented are from an ongoing phase 2a dose escalation study of sotatercept administered subcutaneously every 28 days to evaluate the pharmacokinetics, safety, tolerability, efficacy, and pharmacodynamics of sotatercept for the correction of anemia in patients with ESRD on hemodialysis. Dr. William Smith of Celgene Corporation, Acceleron’s collaboration partner, will present interim safety, pharmacokinetic and hemoglobin data from the first 28-day dose cycle for two dose groups of sotatercept (0.3 mg/kg and 0.5 mg/kg) versus placebo. Following a single dose in the placebo, sotatercept 0.3 mg/kg and sotatercept 0.5 mg/kg dose groups, peak mean hemoglobin changes observed in the first 28 days were 0.1, 0.5 and 0.8 g/dL, respectively. Adverse events were mostly mild to moderate, unrelated to study drug, and generally consistent with patients’ medical histories. No dose-dependent changes in blood pressure were observed.

The data will be presented in a poster presentation on Wednesday April 23rd from 6:00 - 7:30 PM PST.

About the Phase 2a Clinical Trial

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. The first dose group evaluated was a single dose of 0.1 mg/kg of sotatercept administered subcutaneously. Subsequent dose groups to be studied are 0.3, 0.5 and 0.7 mg/kg administered subcutaneously once every four weeks for up to eight cycles of treatment. Each dose group will include up to 12 patients randomized at a 3:1 ratio to receive either sotatercept or placebo. The trial is being conducted at sites in the United States and may enroll up to 56 patients. The primary endpoints are pharmacokinetics and safety. Celgene has completed enrollment in the 0.1, 0.3 and 0.5 mg/kg dose groups and is now enrolling patients in the 0.7 mg/kg dose group. Secondary endpoints in the study include effects on hemoglobin and serum markers of bone metabolism.

In December, 2013, Celgene initiated a second phase 2 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.

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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