ALG-000184 / Aligos Therap - LARVOL DELTA

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 | Not yet recruiting | Sponsor: Aligos Therapeutics

New P2 trial • Hepatitis B • Infectious Disease • Inflammation

Viral kinetics and sequence analysis of a phase I monotherapy study in subjects with chronic hepatitis B reveals a high barrier of resistance to the capsid assembly modulator ALG-000184 (EASL 2025) - No abstract available

Clinical • Monotherapy • P1 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Monotherapy with the novel capsid assembly modulator ALG-000184 for up to 96 weeks results in profound and sustained HBV DNA suppression in untreated subjects with chronic HBV infection (EASL 2025) - No abstract available

Clinical • Monotherapy • Hepatitis B • Infectious Disease

Viral kinetics and sequence analysis of a phase I monotherapy study in subjects with chronic hepatitis B reveals a high barrier of resistance to the capsid assembly modulator ALG-000184 (EASL 2025) - "No viral breakthrough or non-response, as measured by HBV DNA levels was observed in the 21 CHB participants undergoing ALG-000184 monotherapy for up to 96 weeks. Consistently, none of the major ALG-000184 resistance mutations identified in vitro (T33N, T33P and V124G) were detected in any of the baseline or on-treatment samples, indicating a high barrier to resistance. The lack of viral breakthrough and emerging resistance, combined with the significant reduction in HBV DNA, positions ALG-000184 as a promising candidate for further clinical development as a potential backbone of therapy for chronic viral suppression."

Clinical • Monotherapy • P1 data • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Monotherapy with the novel capsid assembly modulator ALG-000184 for up to 96 weeks results in profound and sustained HBV DNA suppression in untreated subjects with chronic HBV infection (EASL 2025) - P1 | "ALG-000184, in combination with ETV for up to 96 weeks, was well tolerated and led to profound suppression of HBV DNA in untreated HBeAg+ subjects with high baseline HBV DNA levels. These results indicate the potential of ALG-000184 in different combination therapies for chronic HBV infection. Full data for 96 weeks of treatment and 8 weeks of follow-up will be shared at the EASL conference."

Clinical • Monotherapy • Hepatitis B • Hepatology • Infectious Disease • Inflammation

The safety and antiviral effect of oral daily 300 mg ALG-000184 in combination with Entecavir for up to 96 Weeks in untreated HBeAg-positive subjects with chronic hepatitis B virus infection (EASL 2025) - P1 | "ALG-000184, in combination with ETV for up to 96 weeks, was well tolerated and led to profound suppression of HBV DNA in untreated HBeAg+ subjects with high baseline HBV DNA levels. These results indicate the potential of ALG-000184 in different combination therapies for chronic HBV infection. Full data for 96 weeks of treatment and 8 weeks of follow-up will be shared at the EASL conference."

Clinical • Combination therapy • Hematological Disorders • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Neutropenia

Aligos Therapeutics Announces Eight Abstracts Accepted for Presentation at the EASL Congress 2025 (GlobeNewswire) - "Aligos Therapeutics...announced eight abstracts have been accepted for poster presentations at the European Association for the Study of the Liver (EASL) Congress 2025, being held May 7 – 10, 2025 in Amsterdam, Netherlands."

Clinical data • Preclinical • Hepatitis B • Metabolic Dysfunction-Associated Steatohepatitis

Monotherapy with the Capsid Assembly Modulator ALG-000184 Results in Rapid Viral Load Reduction and High Viral Suppression Rates in Untreated HBeAg(-) Subjects with Chronic Hepatitis B Virus Infection (APASL 2025) - P1 | "300 mg ALG-000184 monotherapy led to rapid, profound and sustained HBV DNA and RNA viral suppression in untreated HBeAg(-) subjects. Viral suppression exceeds what has been reported previously with nucleos(t)ide analogs, indicating that ALG-000184 monotherapy may be more effective in achieving and maintaining suppression in patients with chronic HBV infection. These data support continuing dosing in this cohort for up to 96 weeks and further evaluation in a Phase 2 clinical trial."

Clinical • Monotherapy • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Monotherapy with the Capsid Assembly Modulator ALG-000184 Results in High Viral Suppression Rates in Untreated HBeAg+ Subjects with Chronic Hepatitis B Virus Infection (APASL 2025) - P1 | "300 mg ALG-000184 monotherapy led to rapid, profound, and sustained HBV DNA and HBV RNA viral suppression in untreated HBeAg+ subjects. Viral suppression exceeds those previously reported with nucleos(t)ide analogs, indicating that ALG-000184 monotherapy may be more effective in achieving and maintaining suppression in patients with chronic HBV infection. These data support continuing dosing in this cohort for up to 96 weeks and further evaluation in a Phase 2 clinical trial."

Clinical • Monotherapy • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Liver Failure

Aligos Therapeutics Presents Positive Data at APASL 2025 (GlobeNewswire) - P1 | N=336 | NCT04536337 | Sponsor: Aligos Therapeutics | "Aligos Therapeutics...today announced positive data from three oral presentations at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL) 2025, being held March 26 - 30, 2025 in Beijing, China....'We are pleased to present preliminary data out to 96 weeks in our Phase 1 study of ALG-000184, which continues to demonstrate first-/best-in-class reductions in important HBV markers....Data from ≤84 weeks following an oral daily dose of 300 mg ALG-000184 monotherapy demonstrated HBV DNA suppression (

P1 data • Hepatitis B

Aligos Therapeutics Reports Recent Business Progress and Fourth Quarter and Full Year 2024 Financial Results (GlobeNewswire) - "'That future looks bright as we move ALG-000184 closer towards a Phase 2 clinical study, which is expected to begin in mid-2025.'...ALG-097558...The NIAID is also sponsoring a drug-drug interaction and relative bioavailability study in healthy volunteers that is expected to start dosing in the second quarter of 2025."

New P2 trial • New trial • Hepatitis B • Infectious Disease • Novel Coronavirus Disease

Aligos Therapeutics Announces $105 Million Private Placement Financing (GlobeNewswire) - "Aligos Therapeutics...today announced that it has entered into a securities purchase agreement for a private placement that is expected to result in gross proceeds of approximately $105 million, before deducting placement agents’ fees and other expenses...Aligos currently expects to use the net proceeds from the private placement, together with its existing cash, cash equivalents and investments, to fund the continued advancement of ALG-000184 into a Phase 2 clinical study in subjects with chronic hepatitis B virus infection (CHB) and for other general corporate purposes...Aligos believes its cash, cash equivalents and investments, including the expected net proceeds from the private placement, will provide sufficient funding of planned operations into the second half of 2026."

Financing • Hepatitis B

A Multi-part Study of ALG-000184 to Evaluate Safety, Tolerability, Pharmacokinetics and Drug-drug Interaction Potential After Single and Multiple Doses in Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Aligos Therapeutics | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

The Discovery and Preclinical Profile of ALG-000184, a Prodrug of the Potent Hepatitis B Virus Capsid Assembly Modulator ALG-001075. (PubMed, J Med Chem) - "ALG-001075 was further advanced through clinical development as the highly soluble prodrug ALG-000184. ALG-000184 is currently being explored in multiple clinical trials in HBV-infected subjects where unprecedented reductions in HBV DNA, RNA and other viral antigens have been observed, making ALG-000184 a promising candidate to become a cornerstone for future chronic suppressive and combination treatment regimens for CHB."

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

A Phase 1 Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of Multiple Doses of ALG-000184. (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Aligos Therapeutics

New P1 trial

Aligos Therapeutics Announces U.S. FDA Clearance of IND Application for ALG-000184 (GlobeNewswire) - "Aligos Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) for a Phase 1 Drug-Drug Interaction (DDI) study of ALG-000184, a capsid assembly modulator (CAM-E) for the treatment of Chronic Hepatitis B (CHB)....In addition, Phase 2 enabling activities are ongoing, with a planned filing in Q1 2025 for the Phase 2 study....'We look forward to finalizing the Phase 2 study design in conjunction with KOLs and the FDA and anticipate enrolling patients next year.'"

IND • New P2 trial • Hepatitis B • Infectious Disease

MONOTHERAPY WITH THE CAPSID ASSEMBLY MODULATOR, ALG-000184, RESULTS IN HIGH VIRAL SUPPRESSION RATES IN UNTREATED HBEAG+ AND HBEAG- SUBJECTS WITH CHRONIC HEPATITIS B OR CHRONIC HEPATITIS B VIRUS INFECTION (AASLD 2024) - P1 | "We previously reported favorable results from cohorts receiving ALG-000184 ± entecavir for ≤ 64 weeks. 300 mg ALG-000184 monotherapy has resulted in rapid, profound and sustained HBV DNA and HBV RNA viral suppression in untreated CHB subjects. These viral suppressive magnitudes exceed those described by nucleos(t)ide analogs, and suggest ALG-000184 monotherapy could become a long-term treatment for chronic suppression in patient with chronic hepatitis B. Longer dosing in this cohort is currently ongoing."

Clinical • Monotherapy • Hepatitis B • Hepatology • Infectious Disease • Inflammation

CAPSID ASSEMBLY MODULATORS SUCH AS ALG-001075 INDUCE PROFOUND HBV DNA KNOCKDOWN AND DIRECTLY TARGET HBEAG IN VITRO (AASLD 2024) - "Here, we reproduce the superior HBV DNA reductions over the nucleoside analog entecavir in vitro and show that CAMs directly target HBeAg. ALG-001075 demonstrated highly pronounced in vitro reductions in HBV DNA and HBeAg, in line with clinical observations for its prodrug ALG-000184, further confirming its best-in-class properties."

Preclinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Extended treatment of HBeAg+ CHB subjects with the Capsid assembly modulator ALG-000184 with or without Entecavir is associated with reductions in viral markers and favorable anti-HBeAb trends (EASL-ILC 2024) - P1 | "Treatment of HBeAg+ CHB subjects with ALG-000184 ± ETV continues to be well tolerated and lowers key viral markers over time. In parallel, an immunologic response may be emerging as evidenced by favorable trends for anti-HBeAb levels."

Clinical • Hematological Disorders • Hepatitis B • Hepatology • Inflammation • Neutropenia

Dosing with the Capsid Assembly Modulator ALG-000184 in Untreated HBeAg Negative CHB Subjects Results in Potent Antiviral Effects Including Suppression of HBV DNA/RNA and Declines in HBcrAg Levels (EASL-ILC 2024) - P1 | "HBcrAg levels (iTACT-HBcrAg assay, LLOQ: <1.8 log10 IU/mL) declined rapidly in the first 28 days of treatment followed by a slower downward trend. Consistent with its in vitro antiviral properties, dosing with ALG-000184 demonstrated dual antiviral effects in untreated HBeAg- CHB subjects: complete suppression of HBV DNA and RNA, suggesting inhibition of HBV replication, as well as reducing HBcrAg levels, indicating inhibition of cccDNA establishment/replenishment."

Clinical • Hepatitis B • Hepatology • Inflammation

Extended treatment of HBeAg+ CHB subjects with the Capsid assembly modulator ALG-000184 with or without Entecavir is associated with reductions in viral markers and favorable anti-HBeAb trends (EASL-ILC 2024) - P1 | "Treatment of HBeAg+ CHB subjects with ALG-000184 ± ETV continues to be well tolerated and lowers key viral markers over time. In parallel, an immunologic response may be emerging as evidenced by favorable trends for anti-HBeAb levels."

Clinical • Hematological Disorders • Hepatitis B • Hepatology • Inflammation • Neutropenia

Association of baseline characteristics and plasma ALG-001075 to HBsAg responses in HBeAg+ CHB subjects following ALG-000184±ETV treatment (EASL-ILC 2024) - P1 | "In Part 4, eligible treatment naïve or currently-not-treated HBeAg+ CHB subjects that enrolled in Cohorts 1 and 2 were randomly assigned (3: 1) to receive oral daily doses of 100 and 300 mg ALG-000184, respectively or placebo in combination with entecavir (ETV) x 12 weeks followed by open-label treatment with 100 mg ALG-000184 + ETV x ≤ 12 weeks and 300 mg ALG- 000184 + ETV x ≤ 96 weeks, respectively. Higher baseline HBsAg (≥4 log10 IU/mL) and plasma ALG-001075 levels appear to be predictors of HBsAg response to ALG-000184 treatment while HBV DNA, RNA, HBeAg and HBcrAg declines are independent of their baseline characteristics."

Clinical • Hepatitis B • Hepatology • Inflammation

Alg-000184 (100 Mg) + Etv Leads to Stronger Antiviral Effects Compared to Etv Alone in Hbeag+ CHB (APASL 2024) - "Part 4 Cohort 1 in Study ALG-000184-201 evaluated the safety and antiviral activity of 100 mg ALG-000184 + Entecavir(ALG- 000184/ETV) vs. placebo + ETV for 12 weeks in a randomized, double blinded manner in untreated HBeAg+ CHB subjects. All AEs were grade 1-2. Dosing of untreated HBeAg+ CHB subjects with 100 mg ALG-000184 + ETV x ≦24 weeks was well tolerated and had greater antiviral effects compared with ETV alone."

Hepatitis B

Alg-000184 Has Favorable Antiviral Effect & Safety in Untreated Asian/Non-Asian Hbeag- CHB Subjects (APASL 2024) - "All reported TEAEs were mild to moderate in severity with no meaningful imbalances across the 2 groups. Dosing x 28 days with 10-100 mg ALG-000184 had comparable safety, tolerability, PK and substantial antiviral activity among untreated Asian and non-Asian HBeAg- CHB subjects."

Clinical • Hepatitis B

Alg-000184 ± Entecavir Results in Substantial HBV Antigen Declines in Untreated Hbeag+ Hepatitis B (APASL 2024) - "Substantial declines in HBV DNA/RNA and antigens have been observed in untreated HBeAg+ CHB subjects receiving 300 mg ALG- 000184 ± ETV x ≦52 weeks. These data suggest ALG-000184 may lower cccDNA levels and may play a central role in future regimens designed to achieve higher rates of functional cure."

Hepatitis B • Hepatology • Infectious Disease • Inflammation