pevifoscorvir sodium (ALG-000184) / Aligos Therap, Xiamen Amoytop Biotech - LARVOL DELTA

Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Aligos Therapeutics | Recruiting ➔ Completed | N=30 ➔ 12

Enrollment change • Trial completion • Hepatitis B • Infectious Disease • Inflammation • Renal Disease

Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Aligos Therapeutics | Recruiting ➔ Completed | Trial completion date: May 2026 ➔ Aug 2026 | Trial primary completion date: Apr 2026 ➔ Aug 2026

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

A Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME) (clinicaltrials.gov) - P2 | N=200 | Active, not recruiting | Sponsor: Aligos Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatitis B • Infectious Disease • Inflammation

Antiviral profile of hepatitis B virus capsid assembly modulator ALG-001075, the parent of pevifoscorvir sodium. (PubMed, Antiviral Res) - "The in vivo efficacy of ALG-001075 was confirmed in adeno-associated virus-HBV mice, where ALG-001075 demonstrated up to 5 log10 reduction in circulating HBV DNA levels. Because of its robust antiviral potency and favorable preclinical resistance profile, ALG-001075 was selected for further clinical development under the form of its prodrug pevifoscorvir sodium."

Journal • Hepatitis B • Infectious Disease • Inflammation

MTE #6: New Hepatitis B Virus and Hepatitis D Virus Treatments Including Drugs in Development (Ticketed) (AASLD 2026) - "This expert session focuses on new treatments for HBV monoinfection and HBV/HDV coinfection including: Capsid assembly modulators (CAMs; eg, pevifoscorvir) Small interfereing RNA (SiRNA; eg, elebsiran) and antisense oligonucleotides (ASO; eg, bepirovirsen) Monoclonal hepatitis B surface (HBs) antibodies (eg, tobevibart) Gene editing nucleases (eg, PBGENE-HBV) Other novel therapies Discussion leaders present a representative case and integrate new clinical trial data to illustrate the role of newer therapies for persons living with HBV or HBV/HDV infection. Evaluate agents in combination for the treatment of HBV/HDV coinfection. List the remaining barriers to HBV and HDV infection cure."

Hepatitis B • Hepatology • Infectious Disease • Inflammation

Aligos Therapeutics Receives Upfront Payment of $25M USD from the Exclusive License Deal of Pevifoscorvir Sodium in Greater China for Chronic Hepatitis B Virus Infection (GlobeNewswire) - "In addition, pevifoscorvir sodium was granted Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). Under the terms of the agreement, Aligos is also eligible to receive up to $420M USD in clinical, regulatory, and sales milestones along with tiered, high single-digit royalties on net sales in Amoytop’s licensed territories."

Breakthrough therapy • Financing • Hepatitis B • Infectious Disease

Pevifoscorvir sodium demonstrated profound antiviral activity in untreated HBeAg+ subjects, regardless of baseline ALT level (EASL 2026) - No abstract available

Clinical • Hepatitis B • Hepatology • Infectious Disease

Sustained reduction of HBV antigen levels at ≥6 months follow-up in HBeAg-positive participants with chronic hepatitis B infection after 96 weeks of 300 mg pevifoscorvir sodium monotherapy (EASL 2026) - No abstract available

Monotherapy • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Potent and durable off-treatment reduction of HBsAg levels and cccDNA-derived transcripts by the CAM-E ALG-001075 in cell-based experiments (EASL 2026) - "Moreover, pevifoscorvir sodium (pevy), a prodrug of ALG-001075, has demonstrated potent reductions of HBV DNA, RNA, HBsAg, HBcrAg and HBeAg in subjects with CHB... Differentiated HepaRG cells were treated from day 6 post-infection with 1 µM ALG-001075 or lamivudine (3TC) for 1 month, then ALG-001075 was either continued for an additional month (arm 1) or stopped (arm 2) and cells monitored off-treatment for 4 weeks... Long term ALG-001075 treatment resulted in profound suppression of HBeAg, HBsAg and intracellular HBV RNAs which was durable after treatment withdrawal in HBV-infected HepaRG cells, suggesting a potential reduction in cccDNA level and/or transcriptional activity in these experimental conditions."

Hepatitis B • Infectious Disease

The potentially best-in-class HBV ASO ALG-170674 demonstrates additive to synergistic antiviral activities when combined with other anti-HBV modalities (EASL 2026) - "Background and aims: Chronic hepatitis B (CHB) patients can achieve a modest rate of functional cure after monotherapy with antisense oligonucleotides (ASO) e.g. bepirovirsen (GSK-836) and AHB-137. ALG-170674 exhibited potential to be a best-in-class HBV ASO. Additive to synergistic effects were observed when combining ALG-170674 and ALG-001075 (or close analogs) in preclinical studies. Combination of ALG-170674 and ALG-000184 could potentially improve functional cure rates in CHB patients, particularly in patients with higher baseline levels of HBsAg."

Hepatitis B • Hepatitis C • Hepatology • Inflammation • IL6 • TLR8

ALG-001075, the parent of pevifoscorvir sodium, exhibits potent in vitro antiviral properties compared to other HBV capsid assembly modulators in clinical development (EASL 2026) - " ALG-001075, canocapavir and neracorvir inhibited HBV DNA production in HepG2.117 cells with EC50 values of 0.64, 5.8 and 24 nM, respectively... ALG-001075, the parent of pevy, displayed a highly potent in vitro antiviral profile, confirming its potential as a best-in-class CAM. Pevy is currently being developed as a monotherapy for the suppression of chronic HBV infection."

Preclinical • Hepatitis B • Hepatology • Inflammation

Pevifoscorvir sodium demonstrated profound antiviral activity in untreated HBeAg+ subjects, regardless of baseline ALT level (EASL 2026) - P1 | "In untreated HBeAg+ subjects, 300 mg PEVY monotherapy for 96 weeks demonstrated favorable safety and potent antiviral activity in both BL low- and high-ALT groups. Moreover, HBeAg and HBcrAg reductions seemed greater in subjects with higher BL ALT."

Clinical • Hepatitis B • Infectious Disease

Population pharmacokinetics of pevifoscorvir sodium (ALG-000184) in healthy participants and participants with chronic hepatitis B in support of phase 2 dose selection (EASL 2026) - "The PK of ALG 001075 in HV and CHB participants was well described by the popPK model. The significant covariates were WT on CL/Q and V2/V3, non-Asian race on CL and V2, and CHB on CL. No dose adjustment was required based on liver disease severity or demographics, supporting fixed dosing in this population."

Clinical • P2 data • PK/PD data • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Sustained reduction of HBV antigen levels at ≥6 months follow-up in HBeAg-positive participants with chronic hepatitis B infection after 96 weeks of 300 mg pevifoscorvir sodium monotherapy (EASL 2026) - P1 | "After the end of the pevy treatment (EOT), these antiviral effects were sustained during an 8-week follow-up (FU) period on entecavir (ETV). Potent on-treatment effects on viral antigens were observed after 96 weeks of 300 mg oral monotherapy with pevy, indicating cccDNA pool reduction. These effects were sustained during ≥24 weeks of ETV FU HBeAg-positive participants with chronic hepatitis B virus infection."

Monotherapy • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Aligos Therapeutics Inc…announced Monday that the U.S. Food and Drug Administration granted fast track designation to pevifoscorvir sodium for treating chronic hepatitis B virus infection. (Investing.com) - "The FDA fast track designation was supported by 96-week Phase 1 data evaluating pevifoscorvir sodium monotherapy in patients with chronic HBV infection."

Fast track • Hepatitis B

ALG-000184-202: Phase 2 Study Evaluating the Efficacy and Safety of ALG-000184 Compared with Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg-nNegative Adult Subjects with Chronic Hepatitis B (B-SUPREME) (clinicaltrialsregister.eu) - P1/2 | N=50 | Recruiting | Sponsor: Aligos Therapeutics Inc.

New P1/2 trial • Hepatitis B • Infectious Disease • Inflammation

Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Aligos Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatitis B • Infectious Disease • Inflammation • Renal Disease

Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Aligos Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Infectious Disease

Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Aligos Therapeutics

New P1 trial • Hepatology • Infectious Disease

Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Aligos Therapeutics

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

ALG-000184 (pevifoscorvir sodium) monotherapy in participants with chronic HBV infection: a phase 1, multicentre, randomised, dose escalation trial. (PubMed, Lancet Gastroenterol Hepatol) - P1 | "ALG-000184 was safe and well tolerated, demonstrated predictable pharmacokinetic properties, and reduced HBV DNA and HBV RNA at all doses regardless of HBeAg status. These results support the evaluation of 300 mg ALG-000184 over longer periods in larger studies to determine its potential role in chronic suppressive therapy, with or without a nucleos(t)ide analogue, or as part of a finite curative regimen."

Journal • Monotherapy • P1 data • Hepatitis B • Infectious Disease • Inflammation • Pain • Respiratory Diseases

A Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects (clinicaltrials.gov) - P1 | N=165 | Completed | Sponsor: Aligos Therapeutics | Active, not recruiting ➔ Completed

First-in-human • Trial completion • Hepatitis B • Infectious Disease • Inflammation

A Phase 1 study of the safety, tolerability, and pharmacokinetics of ALG-000184 (pevifoscorvir sodium), a novel Class E capsid assembly modulator, in healthy participants. (PubMed, Antivir Ther) - P1 | "Urinary excretion of ALG-001075 was low following single or multiple ALG-000184 doses.ConclusionsALG-000184 demonstrated good tolerability, safety and pharmacokinetic properties in healthy participants. The pharmacokinetic profile suggests that a daily dose of 100 mg or higher will provide efficacious exposures in patients with chronic HBV infection.Clinical trial numberNCT04536337 (https://clinicaltrials.gov/study/NCT04536337)."

Clinical • Journal • P1 data • PK/PD data • Hepatitis B • Infectious Disease

CAPSID ASSEMBLY MODULATOR ALG-001075 BINDS AND DIRECTLY TARGETS HBEAG (AASLD 2025) - "ALG-001075 demonstrated direct binding to HBeAg and pronounced in vitro reductions in secreted HBeAg levels, in line with clinical observations for its prodrug ALG-000184, suggesting direct inhibition of HBeAg as a third mechanism of action for ALG-001075. Although the direct HBeAg effect requires higher compound concentrations than the primary and secondary effects of CAMs, the high pharmacokinetic exposure achieved with prodrug ALG-000184 and relative HBeAg-targeting potency of parent ALG-001075 likely enable the clinical observation of this effect."

Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation

SUSTAINED REDUCTION OF HBV ANTIGEN LEVELS DURING THE 8-WEEK FOLLOW-UP PERIOD IN TREATMENT NAÏVE (TN) OR CURRENTLY-NOT-TREATED (CNT) HBEAG-POSITIVE SUBJECTS WITH CHRONIC HEPATITIS B VIRUS INFECTION AFTER 96-WEEK 300 MG ALG-000184, WITH OR WITHOUT ENTECAVIR (ETV) (AASLD 2025) - P1 | "100 or 300 mg ALG-000184 ± ETV for ≤ 24 weeks or ≤ 96 weeks resulted in dose- and duration-dependent multi-log reductions in HBV antigens in TN/CNT HBeAg+ subjects. Additionally, sustained reductions in HBV antigens were observed during the 8-week post-ALG-000184 follow-up period after longer treatment with higher dose of 300 mg ALG-000184. This may indicate cccDNA depletion, associated with the CAM-E secondary mechanism of action."

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation