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- ALG-000184 / Aligos Therap
CAPSID ASSEMBLY MODULATORS SUCH AS ALG-001075 INDUCE PROFOUND HBV DNA KNOCKDOWN AND DIRECTLY TARGET HBEAG IN VITRO () - Oct 15, 2024 - Abstract #AASLD2024AASLD_1007;
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.
- ALG-000184 / Aligos Therap
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 () - Oct 15, 2024 - Abstract #AASLD2024AASLD_949;
P1
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. We previously reported favorable results from cohorts receiving ALG-000184
- ALG-000184 / Aligos Therap
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 (Track Hub: Viral Hepatitis) - May 14, 2024 - Abstract #EASLILC2024EASL_ILC_2800;
P1
We previously reported favorable results from cohorts receiving ALG-000184 Treatment of HBeAg+ CHB subjects with ALG-000184
- ALG-000184 / Aligos Therap
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 (Poster Area) - Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_868;
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.
- ALG-000184 / Aligos Therap
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 (Poster Area) - Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_864;
P1
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. Treatment of HBeAg+ CHB subjects with ALG-000184
- ALG-000184 / Aligos Therap
Association of baseline characteristics and plasma ALG-001075 to HBsAg responses in HBeAg+ CHB subjects following ALG-000184 (Poster Area) - Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_856;
P1
Treatment of HBeAg+ CHB subjects with ALG-000184 In Part 4, eligible treatment na
- ALG-000184 / Aligos Therap
Alg-000184 Has Favorable Antiviral Effect & Safety in Untreated Asian/Non-Asian Hbeag- Chb Subjects () - Jan 6, 2024 - Abstract #APASL2024APASL_2163;
- ALG-000184 / Aligos Therap
Alg-000184 (100 Mg) + Etv Leads to Stronger Antiviral Effects Compared to Etv Alone in Hbeag+ Chb () - Jan 6, 2024 - Abstract #APASL2024APASL_2160;
- ALG-000184 / Aligos Therap
Alg-000184 () - Jan 6, 2024 - Abstract #APASL2024APASL_2154;
- ALG-000184 / Aligos Therap
ALG-000184, a capsid assembly modulator, dosed with entecavir for up to 28 weeks is well tolerated and resulted in substantial declines in surface antigen levels in untreated Hepatitis B e antigen positive subjects with chronic hepatitis B (Poster session) - May 17, 2023 - Abstract #EASLILC2023EASL_ILC_2407;
- ALG-000184 / Aligos Therap
Treatment for up to 24 weeks with the capsid assembly modulator ALG-000184 results in dose related reductions in HBsAg in subjects with HBeAg positive chronic hepatitis B (Poster Area) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_2076;
P1
Importantly, dosing with ALG-000184 plus ETV resulted in dose-dependent, clinically relevant declines in HBsAg, suggesting a potential role of ALG-000184 in combination regimens for functional cure. Figure: Table: Mean BL and change from BL in HBV DNA and HBsAg with ALG-000184 plus ETV or ETV alone HBV DNA HBsAg ALG-000184 100 mg + ETV ALG-000184 300 mg +ETV ETV ALG-000184 100 mg + ETV ALG-000184 300 mg +ETV ETV BL, mean (SEM) 8.6 (0.1) N=8 8.2 (0.3) N=11 8.1 (0.3) N=6 4.7 (0.1) N=8 4.4 (0.2) N=11 4.3 (0.1) N=6 CFB, mean (SEM) - 6.4 (0.2) Week 24 N=4 - 5.4 (0.3) Week 16 N=6 - 3.8 (0.3) Week 12 N=3 - 0.5 (0.1) Week 24 N=4 - 0.5 (0.2) Week 16 N=6 +0.05 (0.02) Week 12 N=3 BL= baseline.
- ALG-000184 / Aligos Therap
Effect of the Capsid Assembly Modulator (CAM) ALG-000184 on HBsAg Levels in Subjects with HBeAg Positive Chronic Hepatitis B (CHB) (2nd floor Poster Area - 244) - Feb 15, 2023 - Abstract #APASL2023APASL_707;
Notably, 3 of 7 evaluable subjects from this cohort experienced HBsAg declines of up to 0.78 log10 IU/mL. These data suggest that ALG-000184 can engage the secondary MoA of CAM II.
- ALG-000184 / Aligos Therap
Preclinical Antiviral, Pharmacological and Toxicological Characteristics of ALG000184, a Prodrug of the Novel HBV Capsid Assembly Modulator ALG001075 (2nd floor Poster Area - 244) - Feb 15, 2023 - Abstract #APASL2023APASL_655;
Based on the potent antiviral activity of ALG-001075 in vitro and in vivo, the high projected human Ctrough levels of ALG-001075 and the favorable safety profile in preclinical species, ALG000184 is currently advancing through Phase I clinical testing in CHB patients. 745
- ALG-000184 / Aligos Therap
ALG-000184, a Capsid Assembly Modulator, Demonstrates Superior Antiviral Activity in Combination with Entecavir Compared to Entecavir in HBeAg Positive Subjects with Chronic Hepatitis B infection (3F North Lounge) - Jan 20, 2023 - Abstract #APASL2023APASL_469;
P1
In untreated HBeAg positive subjects with chronic hepatitis B infection, dosing for 12 weeks with 100 mg ALG-000184 in combination with entecavir was well tolerated, exhibited predictable PK and resulted in a greater mean reduction in HBV DNA and HBV RNA compared to entecavir therapy alone. 660
- ALG-000184 / Aligos Therap
The Capsid Assembly Modulator ALG-000184 Dosed for 28 Days Was Well Tolerated and Rapidly Reduced Viral Markers in Subjects with Chronic Hepatitis B, Including HBsAg in a Subset of HBeAg Positive Subjects with Elevated Baseline ALT (3F North Lounge) - Jan 20, 2023 - Abstract #APASL2023APASL_468;
P1
In addition, HBsAg declines of up to 0.8 log10 IU/mL were observed in a subset of HBeAg positive subjects with elevated baseline ALT levels. 659
- || ALG-000184 / Aligos Therap
Enrollment change, Trial completion date, Trial primary completion date: 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) - Nov 21, 2022
P1, N=336, Recruiting, Sponsor: Aligos Therapeutics
659 N=156 --> 336 | Trial completion date: Jul 2022 --> Jun 2024 | Trial primary completion date: Jul 2022 --> Nov 2023
- || ALG-000184 / Aligos Therap
$ALGS Aligos Therapeutics Initiates 12-Week Dosing Cohort in Phase 1b Study Evaluating Its Class II Capsid Assembly Modulator, ALG-000184 https://t.co/F2d9N6kkgN (Twitter) - Jul 25, 2022
- ALG-000184 / Aligos Therap
Safety, pharmacokinetics, and antiviral activity of the class II capsid assembly modulator ALG-000184 in subjects with chronic hepatitis B (Poster Area) - Mar 16, 2022 - Abstract #EASLILC2022EASL_ILC_1724;
N=156 --> 336 | Trial completion date: Jul 2022 --> Jun 2024 | Trial primary completion date: Jul 2022 --> Nov 2023 All dose levels of ALG-000184 were well tolerated, exhibited predictable PK, and resulted in similar, substantial antiviral activity in untreated CHB subjects, regardless of HBeAg status.
- ALG-000184 / Aligos Therap
[VIRTUAL] SAFETY, PHARMACOKINETICS (PK), AND ANTIVIRAL ACTIVITY OF THE CAPSID ASSEMBLY MODULATOR (CAM) ALG-000184 IN SUBJECTS WITH CHRONIC HEPATITIS B (CHB) () - Oct 21, 2021 - Abstract #AASLD2021AASLD_1075;
In CNT/TN CHB subjects, 100 mg of ALG-000184 given for 28 days was well tolerated, exhibited predictable PK properties, and resulted in HBV DNA and RNA levels <LLOQ for most subjects. Additional doses are being evaluated in ongoing cohorts .
- ALG-000184 / Aligos Therap
[VIRTUAL] Excellent preclinical characteristics of ALG-000184, a prodrug of the HBV capsid assembly modulator ALG-001075 () - Feb 9, 2021 - Abstract #APASL2021APASL_76;
- ||| ALG-000184 / Aligos Therap
Enrollment open: 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) - Nov 17, 2020
P1, N=156, Recruiting, Sponsor: Aligos Therapeutics
Additional doses are being evaluated in ongoing cohorts . Not yet recruiting --> Recruiting
- ALG-000184 / Aligos Therap
[VIRTUAL] BEST-IN-CLASS PRECLINICAL CHARACTERISTICS OF ALG-000184, A PRODRUG OF THE CAPSID ASSEMBLY MODULATOR ALG-001075 FOR THE TREATMENT OF CHRONIC HEPATITIS B () - Oct 11, 2020 - Abstract #AASLD2020AASLD_823;
There was no marked food effect following oral administration of ALG-000184 in dogs. ALG-000184 in a tablet formulation resulted in complete oral absorption and high exposure to ALG-001075 in dogs.
- ALG-020572 / Aligos Therap
[VIRTUAL] DEVELOPMENT OF A BEST-IN-CLASS HBV ASO, ALG-020572, FOR THE TREATMENT OF CHRONIC HEPATITIS B () - Oct 11, 2020 - Abstract #AASLD2020AASLD_84;
Compared with a single ASO, a 1:1 combination of ALG-020572 and ALG-020576 offers enhanced in vivo potency, better genotypic coverage, a higher resistance barrier and a greater capacity to retain efficacy after HBV genome integration events. This regimen can also be combined with other anti-HBV agents.
- ||| ALG-000184 / Aligos Therap
New P1 trial: 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) - Sep 1, 2020
P1, N=156, Not yet recruiting, Sponsor: Aligos Therapeutics
- ALG-000184 / Aligos Therap
[VIRTUAL] ALG-000184, a prodrug of capsid assembly modulator ALG-001075, demonstrates best-in-class preclinical characteristics for the treatment of chronic hepatitis B (Poster Area) - May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-1858;
ALG-000184 demonstrates excellent solubility and oral absorption with efficient conversion to ALG-001075 in vivo, with pharmacokinetic properties across species predicting once daily dosing in humans. ALG-000184 is currently advancing in development as a potential best-in-class CAM.