canocapavir (ZM-H1505R) / Zhimeng Biopharma - LARVOL DELTA

THE SAFETY AND EFFICACY PROFILE OF CANOCAPAVIR IN A PHASE 2 TRIAL: A CAPSID ASSEMBLY MODULATOR FOR LOW-LEVEL VIREMIA TREATMENT (AASLD 2025) - P2a | "The Phase 2 study of Canocapavir (NCT05484466) was conducted to evaluate its safety, tolerability, and efficacy in low-level viremia (LLV) patients with Entecavir (ETV)-treated chronic hepatitis B (CHB) patients... Current results indicate that adjunctive treatment of Canocapavir with ETV was generally well tolerated and effective for LLV patients with reduced HBV DNA to less than 10 IU/mL and maintained. Canocapavir enhanced viral suppression when combined with ETV. These findings support the further development of Canocapavir for the treatment of CHB."

Clinical • P2 data • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Emerging Trends and Future Directions in the Development of Anti-hepatitis B Therapies: A Horizon Scanning Review. (PubMed, Clin Drug Investig) - "The robust and diverse pipeline of novel anti-hepatitis B virus treatments offers promise for improving functional cure rates, but definitive conclusions await longer off-treatment follow-up and durability data. Continued research, rational combination strategies, and global collaboration are crucial to overcome challenges and ensure equitable access to these transformative therapies worldwide."

Journal • Review • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R in Patients With CHB (clinicaltrials.gov) - P3 | N=1300 | Not yet recruiting | Sponsor: Shanghai Zhimeng Biopharma, Inc.

Monotherapy • New P3 trial • Hepatitis B • Infectious Disease • Inflammation

Domestic new drugs have a breakthrough!…Class I new drugs have been included in the breakthrough therapy [Google translation] (Sohu.com) - "On January 8, the official website of the China Food and Drug Administration (CDE) announced that four domestically produced Class I new drugs were to be included in the breakthrough therapy category, which attracted widespread attention...ZM-H1505R is a HBV nucleocapsid inhibitor for chronic hepatitis B."

Breakthrough therapy • Hepatitis B

A Study to Evaluate the Efficacy and Safety of ZM-H1505R in Combination With ETV Compared With ETV Monotherapy in Patients With CHB (clinicaltrials.gov) - P2a | N=90 | Recruiting | Sponsor: Shanghai Zhimeng Biopharma, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2024 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2022

Enrollment open • Trial completion date • Trial primary completion date • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Safety, tolerability, pharmacokinetics, and antiviral activity of the novel core protein allosteric modulator ZM-H1505R (Canocapavir) in chronic hepatitis B patients: a randomized multiple-dose escalation trial. (PubMed, BMC Med) - P1 | "Canocapavir treatment is tolerated with efficacious antiviral activity in CHB patients, supporting its further development in treating HBV infection."

Journal • PK/PD data • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Evaluate the Efficacy and Safety of ZM-H1505R in Combination With ETV Compared With ETV Monotherapy in Patients With CHB (clinicaltrials.gov) - P2a | N=90 | Not yet recruiting | Sponsor: Shanghai Zhimeng Biopharma, Inc.

New P2a trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Multiple-dose Study in Chinese Subjects to Evaluate Safety,Tolerability,PK and PD of ZM-H1505R (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Shanghai Zhimeng Biopharma, Inc.

New P1 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Safety, tolerability, pharmacokinetics, and preliminary antiviral activity of the capsid assembly modulator (CAM) ZM-H1505R after multiple escalatiing oral dosed in patients with chronic hepatitis B virus (CHB) Infection (EASL-ILC 2022) - "Once-a-day oral administration of ZM-H1505R for 28 dayswas safe andwell tolerated. It produced a substantial decrease in HBV-DNA and HBV pgRNA levels in the serum of CHB patients. On the basis of these results, ZM-H1505R was recommended for further evaluation in phase II trials."

Clinical • PK/PD data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Ophthalmology

[VIRTUAL] SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF THE NOVEL HBV CAPSID ASSEMBLY INHIBITOR ZM-H1505R FOLLOWING MULTIPLE ASCENDING DOSES IN HEALTHY SUBJECTS (PART 2) (AASLD 2021) - P1 | "Multiple doses of up to 300 mg of ZM-H1505R were safe and well tolerated in healthy subjects. Its plasma exposure was well above its effective inhibitory concentration and increased in a dose-proportional manner. The safety and PK profile of ZM-H1505R supports its further evaluation in CHB patients."

Clinical • Late-breaking abstract • PK/PD data • Gastroenterology • Gastrointestinal Disorder • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study of Orally Administered ZM-H1505R to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Ascending Doses in Healthy Participants (clinicaltrials.gov) - P1; N=64; Completed; Sponsor: Shanghai Zhimeng Biopharma, Inc.; Recruiting ➔ Completed

Clinical • Trial completion

[VIRTUAL] SAFETY, TOLERABILITY, AND PHARMACOKINETICS (PK) OF THE NOVEL HBV CAPSID ASSEMBLY MODULATOR ZM-H1505R IN HEALTHY SUBJECTS (AASLD 2020) - P1 | "Single doses of up to 450 mg of ZM-H1505R were safe and well tolerated in healthy subjects. The favorable safety and PK profile of ZM-H1505R supports its further evaluation in CHB patients. Evaluation of safety, tolerability, and PK characters of ZM-H1505R following multiple ascending doses in healthy subjects is ongoing (Part 2)."

Clinical • Late-breaking abstract • PK/PD data • Hepatitis B

A Study of Orally Administered ZM-H1505R to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Ascending Doses in Healthy Participants (clinicaltrials.gov) - P1; N=64; Recruiting; Sponsor: Shanghai Zhimeng Biopharma, Inc.; Trial completion date: Jul 2020 ➔ Nov 2020; Trial primary completion date: Jul 2020 ➔ Oct 2020

Clinical • Trial completion date • Trial primary completion date

A Study of Orally Administered ZM-H1505R to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Ascending Doses in Healthy Participants (clinicaltrials.gov) - P1; N=64; Recruiting; Sponsor: Shanghai Zhimeng Biopharma, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open