催化剂Biosciences在国际血栓形成和呼吸症(ISTH)虚拟大会上提出了国际社会的数据

皮下Marzeptacog Alfa(活化)(Marzaa)迅速实现并保持治疗水平

数据确认第3阶段研究设计,治疗血友病中的急性出血事件

南旧金山,加利福尼亚州,7月13日,2020年7月13日(新闻界) -亚博app安装Catalyst Biosciences,Inc。。(纳斯达克:CBIO),今天在国际血栓形成和浩劫(ISTH)虚拟大会上举行了两家海报,举行了2020年7月12日至14日。

第一个题为:“第1阶段研究以评价药代动力学,药效学和升上的药物Marzeptacog Alfa(活化)中的药代动力学和安全性在成人受试者与血友病“(PB0941)包括Maa-102的最终数据,并由Linda Neuman,M.D.,M.B.A.,临床开发,催化剂生物科学副总裁。该研究是在血友病A或B的成人受试者中进行,有或没有抑制剂来评估单个IV剂量和升序的Marzaa的药代动力学,药效动物和升序(单一和多个)剂量。最终数据证明了皮下Marzeptacog Alfa(活化)(Marzaa)的潜力迅速达到和维持治疗水平以治疗血友病中的急性出血事件,并确认为即将到来的第3阶段试验选择的剂量方案,深红色1。

第二张海报,题为:“Marzeptacog Alfa(活性)人口药代动力学(PK):3期试验中剂量选择的模拟,“由Tom Knudsen,DVM,Ph.D.,博士学位,催化剂Biosciences副总裁介绍。开发了一种人口PK模型并用于临床试验模拟。基于1000个受试者的SQ Marzaa的模拟PK,该模型证实,在即将到来的阶段3时24小时内,可以快速实现止血的目标水平,并在即将到24小时内使用60μg/ kg剂量的Sq一次,两次或三次在较新的阶段3时24小时内持续间隔3小时。

“MAA-102 PK结果和人口PK模拟证实,我们为我们的第3阶段审判进行了优化的剂量,在那里我们预计将在2020年底对待第一个患者,”纳西姆USMAN,PH.D.总裁兼首席执行官催化剂官员。“Marzaa解决了皮下治疗出血事件的重要未满足,并且代表了几种出血障碍中的重要市场机会。”

可以访问演示材料的副本活动和演示文稿催化剂网站的一部分。

关于催化剂生物科学
催化剂是一家研究和临床开发生物制药公司,专注于在罕见的血液学和补蛋白介导的疾病中寻求未满足的需求。我们的蛋白酶工程平台包括血友病的两个晚期临床课程;皮下(SQ)补体抑制剂的工程研究计划;和生物原为干燥年龄相关黄斑变性(AMD)的合作临床前发展计划。我们的蛋白酶工程平台产生的产品候选者具有改善的功能和效力,允许:SQ施用重组凝血因子和补体抑制剂;低剂量,高活性基因治疗构建体;并且不太频繁给药玻璃体治疗剂。我们最先进的产品候选人是Marzeptacog Alfa(激活)(Marzaa),下一代SQ FVIIA进入2020年底进入第3阶段注册研究。我们的下一个晚期产品候选人是Dalcinonacog Alfa(Dalca),下一代平方修复,其在血友病B中的个体中的临床试验中表现出疗效和安全性。我们有一个发现阶段因子IX基因治疗构建体 - CB 2679D-GT - 用于血友病B,与帕多瓦变体相比具有显着的优越性临床前模型。 Finally, we have a global license and collaboration agreement with Biogen for the development and commercialization of anti-complement Factor 3 (C3) pegylated CB 2782.

前瞻性陈述
此新闻稿包含前瞻性陈述,涉及具有大量风险和不确定性的陈述。Forward-looking statements include statements about the potential benefits of products based on Catalyst’s engineered protease platform, plans to enroll the first patient into a Phase 3 registration study of MarzAA in late 2020, the potential for MarzAA and DalcA to effectively and therapeutically treat hemophilia subcutaneously, the potential of subcutaneous marzeptacog alfa (activated) (MarzAA) to rapidly achieve and maintain therapeutic levels to treat acute bleeding events in hemophilia, the superiority of CB 2679d-GT over other gene therapy candidates and the Company’s collaboration with Biogen for the development and commercialization of pegylated CB 2782 for the potential treatment of geographic atrophy-associated dry age-related macular degeneration. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially, including, but not limited to, the risk that trials and studies may be delayed as a result of the COVID-19 virus and other factors, that trials may not have satisfactory outcomes, that additional human trials will not replicate the results from earlier trials, that potential adverse effects may arise from the testing or use of DalcA or MarzAA, including the generation of neutralizing antibodies, which has been observed in patients treated with DalcA, the risk that costs required to develop or manufacture the Company’s products will be higher than anticipated, including as a result of delays in development and manufacturing resulting from COVID-19 and other factors, the risk that Biogen will terminate Catalyst’s agreement, competition and other risks described in the “Risk Factors” section of the Company’s quarterly report filed with the Securities and Exchange Commission on May 11, 2020, and in other filings with the Securities and Exchange Commission. The Company does not assume any obligation to update any forward-looking statements, except as required by law.

接触:
Ana Kapor.
Catalyst Biosciences,Inc。
Investors@catbio.com.

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