Replicor宣布NAP前临床安全和药代动力学资料

StephenW

Media Contact:

Natacha Dorget
[email protected]
514-733-1998

Replicor announces publication of pre-clinical safety and pharmacokinetic data on NAPs

MONTREAL, June 12, 2017 – Replicor Inc., a privately held biopharmaceutical company targeting a cure for patients with chronic hepatitis B virus (HBV) and chronic HBV and hepatitis delta virus (HDV) co-infection, announced today the publication of its study on the preclinical evaluation of its clinical NAP candidates REP 2139 and REP 2165 in the journal Molecular Therapy-Nucleic Acids. (http://www.sciencedirect.com/science/article/pii/S2162253117301701).

Replicor’s extensive preclinical assessment of its NAP technology included 6 months exposure to the clinical NAPs REP 2139 or REP 2165 in rodent and non-human primate species, providing extensive pharmacokinetic and safety data on these compounds at doses greatly exceeding those effective clinically.  The publication of these long term pre-clinical exposure studies confirms that the pharmacokinetic behavior of NAPs mirrors that of all other compounds in this drug class (phosphorothioate oligonucleotides) and demonstrates the remarkably minimal toxicities observed in any target organ with REP 2139 or REP 2165.  “These studies also provide details on the development of REP 2165, a NAP which may also have future use in more difficult to treat patient populations.”, Andrew Vaillant, CSO stated. He also commented, “The lack of any significant toxicological findings in the liver in these studies is consistent with our previously published data demonstrating that NAPs are immunologically inert and clearly indicate that the transaminase flares observed in HBV infected patients are not directly caused by NAPs.”

About Replicor

Replicor is a privately held biopharmaceutical company with the most advanced animal and human clinical data in the development of the cure for HBV and HDV. The company is dedicated to accelerating the development of an effective treatment for patients with HBV and HBV/HDV co-infection. For further information about Replicor please visit our website at www.replicor.com.

StephenW

媒体联络人：

Natacha Dorget
[email protected]
514-733-1998




复制者宣布发布国家行动方案前临床安全和药代动力学资料

蒙特利尔，2017年6月12日 - Replicor Inc.是一家私人控股的生物制药公司，旨在治愈慢性乙型肝炎病毒（HBV）和慢性HBV和乙型肝炎病毒（HDV）共感染患者，今天宣布发表研究报告关于临床前评估其临床NAP候选者REP 2139和REP 2165在“分子治疗 - 核酸”杂志上。 （http://www.sciencedirect.com/sci ... i/S2162253117301701）。

复制者对其NAP技术的广泛临床前评估包括6个月暴露于啮齿动物和非人类灵长类物种的临床NAP REP 2139或REP 2165，为剂量大大超过临床有效剂量提供广泛的药代动力学和安全数据。这些长期临床前暴露研究的公布证实，NAPs的药代动力学行为反映了该药物类别中的所有其他化合物（硫代磷酸酯寡核苷酸）的药代动力学行为，并证实在REP 2139或REP 2165的任何靶器官中观察到的显着极小的毒性。 “这些研究还提供了REP 2165的发展细节，REP 2165是一个NAP，也可能在将来使用更难以治疗患者群体。”，CSO的Andrew Vaillant说。他还评论说：“这些研究中肝脏缺乏任何明显的毒理学结果与我们以前发表的数据一致，表明NAPs具有免疫学惰性，并且清楚地表明在HBV感染患者中观察到的转氨酶荧光素不是由NAP直接引起的。 ”

关于复制者

复制者是一家私人持有的生物制药公司，拥有最先进的动物和人类临床资料，用于治疗HBV和HDV。该公司致力于加速HBV​​和HBV / HDV共感染患者的有效治疗发展。有关Replicor的更多信息，请访问我们的网站www.replicor.com。