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Spring Bank在研乙肝新药SB 9200获DSMB批准进行另一项Phase 2a期临床

2017-05-16  来源:肝脏巴士(HeparBus)微信  作者:会飞的喵星人  编辑:放下
导读
专注于病毒感染、炎症性疾病和癌症新型治疗药物开发的临床阶段生物制药公司 Spring Bank 近日宣布,一个独立的医学专家团队机构数据安全监测委员会(DSMB)已经完成了对
 
专注于病毒感染、炎症性疾病和癌症新型治疗药物开发的临床阶段生物制药公司 Spring Bank 近日宣布,一个独立的医学专家团队机构数据安全监测委员会(DSMB)已经完成了对 Spring Bank 的 ACHIEVE 全球 Phase 2a 期临床研究的安全性和耐受性研究数据的审查,Spring Bank 的 ACHIEVE 全球研究是评估 Spring Bank 在研慢乙肝新药 SB 9200 在未经治无肝硬化慢乙肝患者中的安全性、耐受性和抗病毒活性的研究,在该Phase 2a 期临床研究的一个队列 (n=20) 中,SB 9200 为单药治疗,剂量为25mg。基于该药在 Phase 2a 期临床目前队列中的安全性和耐受性数据,数据安全监测委员会批准了加速 ACHIEVE 试验 Phase 2a 期临床另一组队列受试者的入组,该队列的SB 9200 用药剂量将高达50mg每日。
 
Spring Bank 公司亦宣布公司的研究人员已经开始进行 ACHIEVE 试验另一组队列入组患者的初筛工作,该队列将会纳入20名受试对象。
 
Spring Bank 首席医学官 Nezam Afdhal 博士表示“基于DSMB对第一个队列数据的评估结果而授权加速第二组队列单药治疗受试对象的入组,由此可见 SB 9200 良好的耐受性使我我们深受鼓励。我们期待继续进行 ACHIEVE 试验并希望尽快的完成 Phase 2a 期临床的另一组队列的受试对象入组。”
 
SB 9200是一种新型小分子核酸杂交(SMNH)化合物,现被开发单药或联合治疗慢性HBV感染。ACHIEVE 试验的第一部分 Phase 2a 期研究是一项安慰剂对照,序贯队列、双盲试验,旨在评估增加剂量的SB 9200单药治疗12周,随后是替诺福韦(Gilead Sciences,TDF,Viread ®)300mg额外治疗12周。ACHIEVE 试验的Phase 2a部分有一个适应性试验设计,将招募80名年龄在18至70岁之间的慢性HBV感染患者,这些患者已经或将被分配到25mg,50mg,100 mg或200mg SB 9200四个药物剂量组中的一个或安慰剂,每日一次,持续12周。然后所有受试者将每天接受Viread 300 mg,持续12周的治疗。 ACHIEVE试验的Phase 2b期部分旨在检查约200例HBV患者SB 9200和Viread联用的效果。
 
Spring Bank预计在接下来的几周内对ACHIEVE试验的25mg单药治疗剂量队列结果进行报告。
 
 
英文原文
 
Spring Bank Pharmaceuticals Announces the Data Safety Monitoring Board Approves Dose Escalation of SB 9200 for the Second Cohort of the Phase 2a Segment of the ACHIEVE Trial, a Global Phase 2 Clinical Trial for Chronic Hepatitis B Virus (HBV)
 
Begins Screening Patients for Second Cohort of the Global Phase 2a ACHIEVE Trial
 
HOPKINTON, Mass., May 15, 2017 (GLOBE NEWSWIRE) -- Spring Bank Pharmaceuticals, Inc. (Nasdaq:SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, cancer, and inflammatory diseases, announced today that the Data Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring Spring Bank’s ACHIEVE global Phase 2a clinical trial evaluating SB 9200 in treatment-naïve chronic Hepatitis B virus (HBV) patients without cirrhosis, has reviewed the initial safety and tolerability data from the 25mg monotherapy dose cohort (n=20) in the Phase 2a clinical trial of SB 9200. Based on their assessment of the safety data, the DSMB approved proceeding with the enrollment for the second cohort of the Phase 2a segment of the ACHIEVE trial with a dose escalation to 50mg once a day.
 
Spring Bank also announced that study investigators have already begun screening patients for the second cohort of the ACHIEVE trial, which will also enroll 20 patients.
 
“We are encouraged that SB 9200 appeared to be well-tolerated based on the DSMB’s assessment of the data from the first cohort and their authorization to proceed with the second monotherapy dosing cohort,” stated Nezam Afdhal, M.D., chief medical officer of Spring Bank. “We look forward to continuing the ACHIEVE trial and hope to rapidly enroll patients into the second cohort of the Phase 2a segment of the trial.”
 
SB 9200 is a novel small molecule nucleic acid hybrid (SMNH) compound being developed as both monotherapy and combination therapy for the treatment of chronic HBV.  The first segment of the ACHIEVE trial is a Phase 2a placebo-controlled, sequential-cohort, double-blind trial to evaluate increasing doses of SB 9200 as monotherapy for 12 weeks followed by tenofovir disoproxil fumarate (marketed by Gilead Sciences, Inc. as Viread®) 300 mg for an additional 12 weeks.  The Phase 2a segment of the ACHIEVE trial has an adaptive trial design that will enroll 80 chronically-infected HBV patients between 18 and 70 years of age who have been or will be assigned to one of four dosing cohorts, 25 mg, 50 mg, 100 mg or 200 mg of SB 9200, or placebo, once daily for 12 weeks. All subjects will then receive Viread 300 mg once daily for an additional 12 weeks of treatment. The Phase 2b segment of the ACHIEVE trial is designed to examine the concomitant use of SB 9200 and Viread in approximately 200 HBV patients.
 
Spring Bank anticipates reporting top-line results from the 25mg monotherapy dosing cohort of the ACHIEVE trial in the coming weeks.
 
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