Replicor 宣布在 AASLD 2021 上将 REP 2139-Mg 过渡到皮下给药

StephenW

蒙特利尔，2021 年 11 月 1 日——Replicor Inc. 是一家致力于功能性治愈慢性乙型和丁型肝炎感染患者的私人控股生物制药公司，宣布四篇摘要被接受在美国肝脏研究协会 2021 年会议上发表（ AASLD) 将于 2021 年 11 月 12 日至 16 日举行。

REP 2139-Mg 向皮下给药的过渡（最新海报 LB-14）
http://replicor.com/wp-content/u ... ASLD-2021-LP-14.pdf

在 Hôpital Saint Joseph（法国马赛）的 Marc Bourlière 博士监督下，在慢性 HBV / HDV 合并感染的肝硬化患者中善意使用 TDF、低剂量 (90ug) pegIFN 和皮下注射 REP 2139-Mg。 REP 2139-Mg 给药耐受性良好，并且联合治疗伴随着类似的有效抗病毒反应（HBsAg 快速消失和血清转换、HDV RNA 丢失和治疗性转氨酶发作），正如在之前静脉输注 REP 2139-Mg 的临床试验中观察到的那样。

NAPs 快速清除 HBsAg 与功能性治愈相关（海报 840）
http://replicor.com/wp-content/u ... 21-Abstract-840.pdf

作为总统的杰出代表，在 REP 401 研究期间对 HBsAg 动力学的分析是与 Harel Dahari 博士（芝加哥洛约拉大学）实验室持续合作的一部分，证明在基于 NAP 的联合治疗早期 HBsAg 快速单相下降预测功能性治愈。

TDF 单一疗法对 cccDNA 的影响（海报 805）
http://replicor.com/wp-content/u ... 21-Abstract-805.pdf

在 REP 401 研究中，与 Harel Dahari 博士和 Abbot Diagnostics 实验室合作进行的 HBV RNA、HBcrAg 和 ALT 分析表明，在 TDF 单药治疗期间，cccDNA 功能降低。

进一步阐明 NAP 与 DNAJB12 的细胞内靶标相互作用（海报 836）。
http://replicor.com/wp-content/u ... 21-Abstract-836.pdf

与 Patrick Labonté 博士（INRS Institute Armand[1]Frappier，加拿大拉瓦尔）的实验室合作进行的研究表明，NAP 与 DNAJB12 的 pH 敏感相互作用与 ERGIC 内 NAP 的亚病毒颗粒组装的抑制一致。

Replicor 的首席安全官 Andrew Vaillant 博士评论说：“我们第一次通过皮下给药对 REP 2139-Mg 进行初步临床使用，结果符合预期，其良好的耐受性为 REP 2139-Mg 在未来所有临床试验中向皮下给药的过渡铺平了道路。学习”。

StephenW

Replicor announces transition of REP 2139-Mg to subcutaneous administration at AASLD 2021

MONTREAL, November 1st, 2021 – Replicor Inc., a privately held biopharmaceutical company targeting functional cure for patients with chronic hepatitis B and D infection, announced four abstracts accepted for presentation at the 2021 meeting of the American Association for the Study of the Liver (AASLD) to be held virtually November 12-16, 2021.

Transition of REP 2139-Mg to subcutaneous administration (late breaking poster LB-14)
http://replicor.com/wp-content/u ... ASLD-2021-LP-14.pdf
Compassionate use of TDF, low dose (90ug) pegIFN and subcutaneously administered REP 2139-Mg in a cirrhotic patient with chronic HBV / HDV co-infection was supervised by Dr. Marc Bourlière at the Hôpital Saint Joseph (Marseille, France). REP 2139-Mg administration was well tolerated, and the combination therapy was accompanied by similar potent antiviral response (rapid HBsAg loss and seroconversion, HDV RNA loss and therapeutic transaminase flare) as observed in previous clinical trials with intravenous infusion of REP 2139-Mg.

Rapid HBsAg clearance with NAPs is associated with establishment of functional cure (poster 840)
http://replicor.com/wp-content/u ... 21-Abstract-840.pdf

A Presidential poster of distinction, this analysis of HBsAg kinetics during the REP 401 study is part of an ongoing collaboration with the lab of Dr. Harel Dahari (Loyola University, Chicago) demonstrating that rapid monophasic decline in HBsAg early in NAP-based combination therapy predicts functional cure.

Effects of TDF monotherapy on cccDNA (Poster 805)
http://replicor.com/wp-content/u ... 21-Abstract-805.pdf

Performed in collaboration with the lab of Dr. Harel Dahari and Abbot Diagnostics, analysis of HBV RNA, HBcrAg and ALT demonstrate reduction of cccDNA function during TDF monotherapy in the REP 401 study.

Further elucidation of the intracellular target interaction of NAPs with DNAJB12 (poster 836).
http://replicor.com/wp-content/u ... 21-Abstract-836.pdf

Ongoing studies performed in collaboration with the lab of Dr. Patrick Labonté (INRS Institute Armand[1]Frappier, Laval, Canada) demonstrate the pH sensitive interaction of NAPs with DNAJB12 consistent with the inhibition of subviral particle assembly of NAPs within the ERGIC.

Dr. Andrew Vaillant, CSO of Replicor commented, “Our first initial clinical use of REP 2139-Mg by subcutaneous administration performed as expected and its well tolerated nature paves the way for the transition of REP 2139-Mg to subcutaneous administration in all future clinical studies”.