Zhimeng Biopharma will report positive phase 1b trial results on its HBV capsid inhibitor ZM-H1505R in the upcoming International Liver Congress

SHANGHAI,June 14,2022 -- 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,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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