本帖最后由 sir 于 2019-12-27 00:44 编辑
HOPKINTON, Mass., Dec. 26, 2019 (GLOBENEWSWIRE) -- Spring Bank Pharmaceuticals, Inc. (Nasdaq: SBPH), a clinical-stagebiopharmaceutical company developing novel therapeutics for the treatment ofviral infections, inflammatory diseases and certain cancers, today announcedthat the company has stopped dosing and enrolling patients in its Phase 2bCATALYST trials, which are examining the use of inarigivir soproxil 400mg forthe treatment of chronic hepatitis B virus (HBV). In addition, the company hasstopped dosing and enrollment in all other studies of inarigivir in subjectswith chronic HBV. The decision to stop the dosing ofinarigivir 400mg in the Phase 2b CATALYST trials was due to clinical findingsobserved in the CATALYST 2 trial of virally-suppressed chronic HBV patients.Laboratory findings revealed that three subjects participating in this trialshowed evidence of hepatocellular dysfunction and an elevation of alaninetransaminase (ALT) potentially consistent with liver injury rather than immuneflares. The company is investigating and analyzing the data to gain a betterunderstanding of the findings and potential causes thereof and is furtherevaluating safety data across the almost 100 patients who have receivedinarigivir at this dose. “We stopped dosing and enrolling patientsout of an abundance of caution based on laboratory data from virally-suppressedpatients in the CATALYST 2 trial. We are certainly disappointed to stop ourcurrent Phase 2 inarigivir trials, but ensuring patient safety and care is ofparamount importance to us,” said Martin Driscoll, president and chiefexecutive officer of Spring Bank. “Working with the members of our Data SafetyMonitoring Board, clinical trial investigators and external experts, we willreview all of the information available to us from the CATALYST 2 trial and allother inarigivir trials at the 400mg dose to determine the appropriate pathforward for these trials.” 马萨诸塞州霍普金顿，2019年12月26日（环球新闻社）--Spring Bank Pharmaceuticals，Inc.（纳斯达克：SBPH），一家临床阶段生物制药公司，开发用于治疗病毒感染、炎症疾病和某些癌症的新疗法，今天宣布，该公司已停止给药和登记患者在其2B期的试验中，正在研究使用伊那吉韦索普西尔400 mg治疗慢性乙型肝炎病毒（HBV）。此外，该公司已经停止了伊那吉韦治疗慢性乙型肝炎患者的所有其他研究的给药和注册。
在2b期试验中，决定停止给药伊那吉韦400mg是因为在试验中观察到了慢性乙型肝炎病毒病毒抑制患者的临床结果。实验室结果显示，三名参与该试验的受试者显示肝细胞功能障碍和丙氨酸转氨酶（ALT）升高的迹象，这可能与肝损伤而不是免疫爆发有关。该公司正在调查和分析这些数据，以便更好地了解调查结果及其潜在原因，并正在进一步评估近100名接受这种剂量伊那吉韦治疗的患者的安全性数据。 “根据Catalyst2试验中病毒抑制患者的实验室数据，我们出于充分的谨慎而停止给药和登记患者。我们当然对停止目前的第二阶段inarigivir试验感到失望，但确保患者的安全和护理对我们来说至关重要，”SpringBank总裁兼首席执行官Martin Driscoll说。“与我们的数据安全监测委员会成员、临床试验研究人员和外部专家合作，我们将审查CATALYST 2试验和所有其他400毫克剂量的inarigivir试验提供给我们的所有信息，以确定这些试验的适当前进道路。”
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发表于 2019-12-27 00:44
