智盟生物将在即将召开的国际肝病大会上报告其HBV衣壳抑制

StephenW

智盟生物将在即将召开的国际肝病大会上报告其HBV衣壳抑制剂ZM-H1505R的1b期阳性试验结果
发布时间：美国东部时间 2022 年 6 月 14 日上午 8:00

上海，2022 年 6 月 14 日 /美通社/ -- 上海智盟生物制药宣布将于 2022 年 6 月 22 日至 26 日在国际肝病大会上报告其 HBV 衣壳抑制剂 ZM-H1505R 的 1b 期研究取得的阳性结果（ EASL 会议）。最近完成的 1b 期研究是在一项双盲、随机、安慰剂对照、剂量递增研究中评估 ZM-H1505R 在初治慢性乙型肝炎中的安全性、耐受性、药代动力学 (PK) 和初步抗病毒活性。 CHB) 患者。患者被分为三个队列（每个队列 10 名患者）并在每个队列中以 4:1 的比例随机接受 50、100 或 200 mg 的 ZM-H1505R 或安慰剂的递增剂量，每天一次，连续 28 天. ZM-H1505R 在该剂量范围内是安全且耐受性良好的，大多数 AE 的严重程度为轻度至中度。没有观察到 SAE，也没有因 AE 而退出。在 ZM-H1505R 的剂量和血浆暴露量之间观察到比例关系。在第 28 天，50、100 和 200 mg 剂量的平均血浆 Cmin 分别是其蛋白质结合调整的 HBV DNA EC50 的 2.73、7.05 和 14.56 倍。用 ZM-H1505R 治疗 28 天后，血清 HBV DNA 和 HBV pgRNA 水平较基线显着降低。在 50、100 和 200 mg 队列中，HBV DNA 从基线的平均最大减少为 -1.54、-2.50 和 -2.75 log10 IU/mL，HBV pgRNA 为 -1.53​​、-2.35 和 -2.34 log10 IU/mL，分别。在 100 和 200 mg 队列中，HBcrAg 从基线的平均最大下降分别为 -0.61 和 -0.51 log10 IU/mL。

“我们很高兴从这项 1b 期研究中看到 ZM-H1505R 的积极安全性和初步疗效结果。”智盟生物制药首席执行官陈焕明博士评论道。 “我们相信，诸如 ZM-H1505R 等 HBV 衣壳抑制剂将在进一步减少长期接受 NA 治疗但病毒血症水平仍然较低的患者中发挥重要作用。我们也相信 ZM- H1505R有可能成为CHB功能性治愈联合疗法的一个组成部分。鉴于ZM-H1505R取得如此可喜的结果，我们将在2022年第三季度启动2期临床试验，以进一步评估其安全性和有效性。”

关于ZM-H1505R

ZM-H1505R是一种小分子HBV衣壳组装调节剂，具有新型吡唑结构，目前正在评估用于治疗慢性乙型肝炎（CHB）。它对大多数对其他 HBV 衣壳调节剂表现出抗性的 HBV 变体具有活性。

关于智盟生物

智盟生物制药是一家临床阶段的生物制药公司，致力于开发用于治疗慢性乙型肝炎（CHB）和严重神经系统疾病的创新药物，医疗需求尚未得到满足。该公司最近宣布于 2022 年 3 月在美国启动其为 CHB 开发的新型 TLR8 激动剂的首次人体 I 期研究；以及 2022 年 5 月在美国开发的用于治疗难治性癫痫的新型小分子 KCNQ2/3 选择性开放剂的首次人体 I 期研究。

欲了解更多信息，请访问：www.corebiopharma.com

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消息来源上海智盟生物制药有限公司

上述新闻稿由美通社提供。新闻稿中的观点、意见和声明未经葛瑞传媒集团的认可，也不一定陈述或反映葛瑞传媒集团的观点、意见和声明。

StephenW

Zhimeng Biopharma will report positive phase 1b trial results on its HBV capsid inhibitor ZM-H1505R in the upcoming International Liver Congress
Published: Jun. 14, 2022 at 8:00 AM EDT

SHANGHAI, June 14, 2022 /PRNewswire/ -- Shanghai Zhimeng Biopharma announces that it will report the positive results obtained from a phase 1b study on its HBV capsid inhibitor ZM-H1505R in the International Liver Congress in June 22-26, 2022 (the EASL meeting).  The recently completed phase 1b study was to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antiviral activity of ZM-H1505R in a double-blind, randomized, placebo-controlled, dose escalating study in treatment-naïve chronic hepatitis B (CHB) patients. Patients were divided into three cohorts (10 patients each) and randomized within each cohort in a ratio of 4:1 to receive an ascending dose of 50, 100, or 200 mg of ZM-H1505R, or placebo once a day for 28 consecutive days. ZM-H1505R was safe and well tolerated within this dose range, with most AEs being mild to moderate in severity. No SAE was observed and there was no withdrawal due to AE. A proportional relationship was observed between dose and plasma exposure of ZM-H1505R. At day 28, the mean plasma Cmin were 2.73, 7.05, and 14.56 folds of its protein-binding adjusted HBV DNA EC50 for 50, 100, and 200 mg doses, respectively. Serum levels of HBV DNA and HBV pgRNA were significantly reduced from baselines after 28 days of treatment with ZM-H1505R. The mean maximal reductions from baselines in HBV DNA were -1.54, -2.50 and -2.75 log10 IU/mL, and in HBV pgRNA were -1.53, -2.35 and -2.34 log10 IU/mL in the 50, 100 and 200 mg cohorts, respectively. The mean maximal declines from baseline in HBcrAg were -0.61 and -0.51 log10 IU/mL in the 100 and 200 mg cohorts, respectively.

"We are pleased to see the positive safety and preliminary efficacy results of ZM-H1505R from this phase 1b study." Commented Dr. Huanming Chen, CEO of Zhimeng Biopharma. "We believe that HBV capsid inhibitors such as ZM-H1505R will play an important role in further reducing the viruses in patients who have been treated with a NA for a long time but still have low levels of viremia. We are also confident that ZM-H1505R may become a component of a combination therapy for functional cure of CHB. With such promising results of ZM-H1505R, we will initiate a phase 2 trial in Q3 of 2022 to further evaluate its safety and efficacy".

About ZM-H1505R

ZM-H1505R is a small-molecule HBV capsid assembly modulator with a novel pyrazole structure currently being evaluated for the treatment of chronic hepatitis B (CHB). It is active against most HBV variants that show resistance to other HBV capsid modulators.

About Zhimeng Biopharma

Zhimeng Biopharma is a clinical-stage biopharmaceutical company committed to developing innovative drugs for the treatment of chronic hepatitis B (CHB) and severe neurological diseases with significant unmet medical needs. The company has recently announced the launch of the first-in-human phase I study of its novel TLR8 agonist, developed for CHB, in the US in March 2022; and the first-in-human phase I study of its novel small molecule, KCNQ2/3 selective opener, developed for the treatment of refractory epilepsy, in the US in May 2022.

For more information, please visit: www.corebiopharma.com

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SOURCE Shanghai Zhimeng Biopharma, Inc.

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