Replicor 通过同情使用皮下 REP 2139-Mg 扩大了失代偿期肝硬化的

StephenW

Replicor 通过同情使用皮下 REP 2139-Mg 扩大了失代偿期肝硬化的疗效和安全性

蒙特利尔，2022 年 9 月 22 日——Replicor Inc. 在 2022 年 9 月 18 日至 21 日在巴黎举行的 2022 年国际 HBV 会议上展示了其扩大的同情使用计划用于治疗肝硬化患者慢性 HBV/HDV 合并感染的最新临床数据（见这里）。

Replicor 在法国的扩大使用计划现在包括 5 名晚期 HBV/HDV 合并感染患者，4 名代偿性肝硬化患者在布列维肽治疗失败和 5 名失代偿期肝硬化患者。 Andrew Vaillant 博士（Replicor 的 CSO）介绍了这些患者治疗进展的最新情况（见此处）。

迄今为止，所有患者都对 REP 2139-Mg 与 TDF + pegIFN 的每周皮下治疗具有良好的耐受性。一名患者已完成治疗，并在去除 REP 2139-Mg 和 pegIFN 治疗后两个月内保持检测不到 HBsAg 和 HDV RNA，抗 HBsAg 滴度增加，肝功能正常。

其他 3 名代偿期肝硬化患者的 HDV RNA 和 HBsAg 明显下降，其中 2 名患者在治疗早期实现了 HBsAg 和 HDV RNA 消除至无法检测的水平。

REP 2139-Mg + TDF 在伴有 HBsAg 消失和 HDV RNA 下降的失代偿期肝硬化患者中具有良好的耐受性。该患者最初的明显腹水在 4 周内迅速逆转，并且在没有利尿剂的情况下稳定。

Vaillant 博士评论说：“我们继续在法国和其他国家扩大我们的同情使用计划，现在为患有非常晚期肝病的患者提供 REP 2139-Mg 用于严重的 HBV/HDV 合并感染病例。这一宝贵的临床经验将为未来以皮下给药 REP 2139-Mg 和扩大的纳入标准（包括肝硬化参与者）为特征的 II 期试验铺平道路”。

关于 Replicor

Replicor 是一家私营生物制药公司，在开发 HBV 和 HDV 治疗方法方面拥有最先进的动物和人类临床数据。公司致力于加速开发针对 HBV 和 HBV/HDV 合并感染患者的有效治疗方法。有关 Replicor 的更多信息，请访问我们的网站 www.replicor.com。

StephenW

Replicor expands efficacy and safety envelope in decompensated cirrhosis with compassionate use of subcutaneous REP 2139-Mg

MONTREAL, September 22nd, 2022 – Replicor Inc., presented updated clinical data from its expanded compassionate use program for treating chronic HBV/HDV co-infection in cirrhotic patients at the 2022 International HBV Meeting held September 18 - 21, 2022 in Paris (see here).

Replicor’s expanded use program in France now includes 5 patients with advanced HBV/HDV co-infection, 4 with compensated cirrhosis who failed on bulevirtide therapy and a fifth with decompensated cirrhosis. Dr. Andrew Vaillant (CSO of Replicor) presented updates on the progress of therapy in these patients (see here).

Weekly subcutaneous therapy of REP 2139-Mg with TDF + pegIFN has been well tolerated in all patients to date.  One patient has completed therapy and maintains undetectable HBsAg and HDV RNA with increasing anti-HBsAg titers and normal liver function for two months after removing REP 2139-Mg and pegIFN therapy.

Strong HDV RNA and HBsAg declines are occurring in the other 3 patients with compensated cirrhosis, with two achieving HBsAg and HDV RNA elimination to undetectable levels early in therapy.

REP 2139-Mg + TDF has been well tolerated in the patient with decompensated cirrhosis with HBsAg loss and decline in HDV RNA already achieved.  Initial significant ascites in this patient rapidly reversed within 4 weeks and is stable in the absence of diuretics.

Dr. Vaillant commented, “we continue to expand our compassionate use program in France and other countries and now in patients with very advanced liver disease to offer REP 2139-Mg for critical cases of HBV/HDV co-infection.  This invaluable clinical experience will pave the way for future phase II trials featuring subcutaneously administered REP 2139-Mg and expanded inclusion criteria including cirrhotic participants”.

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.