AiCuris在I期试验中发现慢性乙型肝炎候选药物是安全的

StephenW

AiCuris finds chronic hepatitis B drug candidate safe in Phase I trial
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German drug development company AiCuris Anti-infective Cures has reported positive results from the Phase I clinical trial of AIC649 for the treatment of chronic hepatitis B (CHB).

Data obtained during the multi-centre trial showed a single intravenous dose of AIC649 to be safe and well-tolerated in all dose groups.

AIC649 is designed using inactivated parapoxvirus particles to trigger a natural, self-limiting immune response. This is intended to maximise the required immune responses against unrelated viruses.

The immunomodulator activity of AIC649 is said to possess the potential to act as a functional cure for hepatitis B virus (HBV) infection.

AiCuris performed the randomised, double-blind, placebo-controlled Phase I trial to evaluate the safety, tolerability and pharmacodynamics of intravenous AIC649 doses in a total of 32 chronic hepatitis B patients.
“These results from a first-in-human clinical trial are very encouraging.”

Across the four ascending-dose groups in the trial, subjects were administered with single AIC649 dosages or placebo. The participants were then monitored for 84 days.

The chronic hepatitis B candidate did not demonstrate any dose-limiting toxicity. In addition, its highest administered dose did not reach the maximum tolerated dose.

AiCuris further reported that the heterogeneity of the trial subjects did not affect the stimulation of the patients’ immune system when given a single dose of AIC649.

AiCuris Anti-infective Cures CEO Holger Zimmermann said: “These results from a first-in-human clinical trial are very encouraging.

“They clearly support our commitment to progressing the clinical development of AIC649, a promising candidate from our broad development pipeline of anti-infective compounds with the potential to induce functional cure in HBV-infected patients.”

The company is currently working towards increasing the production of AIC649 for future clinical trials.

StephenW

AiCuris在I期试验中发现慢性乙型肝炎候选药物是安全的
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德国药物开发公司AiCuris Anti-infective Cures报道了AIC649用于治疗慢性乙型肝炎（CHB）的I期临床试验的阳性结果。

在多中心试验期间获得的数据显示，在所有剂量组中，单次静脉内剂量的AIC649是安全且耐受良好的。

AIC649使用灭活的副痘病毒颗粒设计，以触发自然的，自限性的免疫反应。这旨在最大化针对不相关病毒的所需免疫应答。

据说AIC649的免疫调节剂活性具有作为乙型肝炎病毒（HBV）感染的功能性治愈的潜力。

AiCuris进行了随机，双盲，安慰剂对照的I期试验，以评估静脉注射AIC649剂量在32名慢性乙型肝炎患者中的安全性，耐受性和药效学。
“首次人体临床试验的这些结果非常令人鼓舞。”

在试验中的四个递增剂量组中，受试者施用单一AIC649剂量或安慰剂。然后监测参与者84天。

慢性乙型肝炎候选人未表现出任何剂量限制性毒性。此外，其最高给药剂量未达到最大耐受剂量。

AiCuris进一步报道，当给予单剂量的AIC649时，试验受试者的异质性不影响患者免疫系统的刺激。

AiCuris Anti-infective Cures首席执行官Holger Zimmermann说：“这些首次人体临床试验的结果非常令人鼓舞。

“他们明确支持我们致力于推动AIC649临床开发的承诺，AIC649是我们广泛开发的抗感染化合物的有希望的候选药物，具有诱导HBV感染患者功能性治愈的潜力。”

该公司目前正致力于为未来的临床试验增加AIC649的产量。