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- | daplusiran/tomligisiran (GSK5637608) / GSK, ARC-520 / Arrowhead
Journal: Long-term hepatitis B surface antigen response after finite treatment of ARC-520 or JNJ-3989. (Pubmed Central) - Feb 6, 2025
Short-duration siRNA treatment suppressed HBsAg expression with a prolonged effect for up to 6 years in some participants.
- bepirovirsen (GSK3228836) / GSK
SEMI-MECHANISTIC PK/PD MODELING AND SIMULATION OF SEQUENTIAL SIRNA AND BEPIROVIRSEN TREATMENT PREDICTS ADDED BENEFIT IN HBSAG RESPONSE IN SUPPORT OF PHASE 2B DOSE SELECTION () - Oct 15, 2024 - Abstract #AASLD2024AASLD_1039;
The PK-HBsAg model-based simulation results predict an added benefit of sequential DAP/TOM followed by bepirovirsen therapy versus bepirovirsen plus SOC alone due to lowering HBsAg levels with siRNA before starting bepirovirsen treatment. These results support the evaluation of this sequential regimen in a Phase 2b study.
- ||||| daplusiran/tomligisiran (GSK5637608) / GSK, bepirovirsen (GSK3228836) / GSK
New P2 trial: B-UNITED: A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - Aug 4, 2024
P2, N=280, Not yet recruiting, Sponsor: GlaxoSmithKline
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Phase classification: A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Jul 31, 2024
P2, N=130, Completed, Sponsor: Janssen Sciences Ireland UC
These results support the evaluation of this sequential regimen in a Phase 2b study. Phase classification: P2b --> P2
- || daplusiran/tomligisiran (GSK5637608) / GSK
Trial completion: OCTOPUS-1: An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants (clinicaltrials.gov) - Jul 18, 2024
P2, N=37, Completed, Sponsor: Janssen Research & Development, LLC
Phase classification: P2b --> P2 Active, not recruiting --> Completed
- || daplusiran/tomligisiran (GSK5637608) / GSK, JNJ-64300535 / J&J
Trial completion: OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Jul 18, 2024
P1, N=24, Completed, Sponsor: Janssen Research & Development, LLC
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Phase classification: REEF-1: A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Jul 9, 2024
P2, N=471, Completed, Sponsor: Janssen Sciences Ireland UC
Active, not recruiting --> Completed Phase classification: P2b --> P2
- | daplusiran/tomligisiran (GSK5637608) / GSK
Trial completion date: REEF-D: A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus (clinicaltrials.gov) - May 22, 2024
P2, N=52, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Phase classification: P2b --> P2 Trial completion date: Aug 2026 --> Feb 2025
- daplusiran/tomligisiran (GSK5637608) / GSK
Viral sequence analysis of chronic hepatitis B (CHB) patients treated with the silencing RNA (siRNA) JNJ-3989 in the REEF-1 and REEF-2 clinical studies (Track Hub: Viral Hepatitis) - May 14, 2024 - Abstract #EASLILC2024EASL_ILC_2798;
P2b
In JNJ-3989-treated patients who discontinued all treatment and experienced VR, variants within the X-trigger target region were frequently observed during VR but were not selected on-treatment, suggesting that these X-trigger variants developed off-treatment in JNJ-3989 treated patients. Presence of these variants did not impact off-treatment HBsAg kinetics.
- daplusiran/tomligisiran (GSK5637608) / GSK, JNJ-64300535 / J&J
Efficacy, safety, tolerability, and immunogenicity of JNJ-0535 following a reduction of viral antigen levels through administration of siRNA JNJ-3989 in patients with chronic HBeAg negative hepatitis B - interim data of the OSPREY study (Poster Area) - Apr 29, 2024 - Abstract #EASLILC2024EASL_ILC_2754;
- daplusiran/tomligisiran (GSK5637608) / GSK
Robust reduction of HBsAg and HDV RNA levels with low risk for ALT elevations in JNJ-73763989 treated patients with chronic hepatitis D (CHD) and baseline HBsAg levels below 10,000 IU/mL: part 2 of the REEF-D study (Poster Area) - Apr 29, 2024 - Abstract #EASLILC2024EASL_ILC_2714;
- daplusiran/tomligisiran (GSK5637608) / GSK
A phase 2 open-label study to evaluate safety, tolerability, efficacy, and pharmacodynamics of JNJ-73763989, nucleos(t)ide analogs, and a low-dose PD-1 inhibitor in patients with chronic hepatitis B (Gold Room) - Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_1335;
Cross-study analysis of JNJ-3989 with VS, HBeAg- patients in REEF-1 did not show an apparent benefit of JNJ-3989 loading dose or nivolumab. Treatment was generally safe and well tolerated but administration of low-dose nivolumab in the study was terminated due to observed TSH suppression.
- daplusiran/tomligisiran (GSK5637608) / GSK, ARC-520 / Arrowhead
Long-term hepatitis B surface antigen response after finite treatment with siRNAs ARC-520 or JNJ-3989 (Gold Room) - Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_1334;
P1/2, P2
siRNA treatment suppressed HBsAg expression with a prolonged effect for up to 6 years. The siRNA-100 score consisting of baseline qHBsAg and log reduction at nadir may be indicative of HBsAg level <100 IU/mL at LFU.
- daplusiran/tomligisiran (GSK5637608) / GSK
Intrahepatic changes in immunologic and virologic markers during siRNA JNJ-73763989 (JNJ-3989) based treatment of chronic hepatitis B (CHB) patients: imaging mass cytometry (IMC) analyses from the INSIGHT study (Poster Area) - Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_860;
The siRNA-100 score consisting of baseline qHBsAg and log reduction at nadir may be indicative of HBsAg level <100 IU/mL at LFU. In INSIGHT, CHB patients who were hepatitis B e-antigen (HBeAg) positive and not currently treated (Group 1) or HBeAg
- daplusiran/tomligisiran (GSK5637608) / GSK
Downregulation of soluble FASLG as a potential mechanism of enhanced immune-related clearance of infected hepatocytes induced by JNJ-73763989 in HBeAg-negative virologically suppressed chronic hepatitis B patients (Poster Area) - Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_859;
Serum proteomic analyses in VS HBeAg negative patients across two clinical studies showed that JNJ-3989 treatment reduces soluble FASLG and increases serum levels of intracellular hepatocyte proteins, suggestive of increased hepatocyte cell death. As soluble FASLG can interfere with the pro-apoptotic action of cytotoxic T/NK cells through steric hinderance of the membrane bound FAS/FASLG interaction, these data suggest JNJ-3989 treatment might improve clearance of infected hepatocytes by cytotoxic immune cells through restoration of FAS/FASLG mediated apoptotic signaling.
- daplusiran/tomligisiran (GSK5637608) / GSK
Viral sequence analysis of chronic hepatitis B (CHB) patients treated with the silencing RNA (siRNA) JNJ-3989 in the REEF-1 and REEF-2 clinical studies (Poster Area) - Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_857;
P2b
In JNJ-3989-treated patients who discontinued all treatment and experienced VR, variants within the X-trigger target region were frequently observed during VR but were not selected on-treatment, suggesting that these X-trigger variants developed off-treatment in JNJ-3989 treated patients. Presence of these variants did not impact off-treatment HBsAg kinetics.
- ||| daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Trial completion: A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - Mar 27, 2024
P2, N=54, Completed, Sponsor: Janssen Research & Development, LLC
Presence of these variants did not impact off-treatment HBsAg kinetics. Active, not recruiting --> Completed
- || daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Biomarker, Trial completion: INSIGHT: A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Mar 5, 2024
P2, N=24, Completed, Sponsor: Janssen Research & Development, LLC
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | daplusiran/tomligisiran (GSK5637608) / GSK, JNJ-64300535 / J&J
Trial primary completion date: OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Feb 15, 2024
P1, N=24, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Active, not recruiting --> Completed Trial primary completion date: Jun 2024 --> Jul 2023
- || daplusiran/tomligisiran (GSK5637608) / GSK
Trial primary completion date: REEF-D: A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus (clinicaltrials.gov) - Feb 15, 2024
P2, N=52, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Jun 2024 --> Jul 2023 Trial primary completion date: Aug 2026 --> Oct 2023
- daplusiran/tomligisiran (GSK5637608) / GSK, JNJ-64300535 / J&J
Phase classification: OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Dec 6, 2023
P1, N=24, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Aug 2026 --> Oct 2023 Phase classification: P1b --> P1
- || daplusiran/tomligisiran (GSK5637608) / GSK
Trial primary completion date: REEF-D: A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus (clinicaltrials.gov) - Dec 6, 2023
P2, N=52, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Phase classification: P1b --> P1 Trial primary completion date: Oct 2023 --> Aug 2026
- JNJ-3989 / J&J
INTRAHEPATIC CHANGES IN VIRAL AND IMMUNE MARKERS FOLLOWING TREATMENT WITH JNJ-73763989 (JNJ-3989) AND NUCLEOS(T)IDE ANALOGS (NAS), IN PATIENTS WITH CHRONIC HEPATITIS B (CHB): INSIGHT WEEK 40 (W40) INTERIM RESULTS (Room 304/306) - Oct 11, 2023 - Abstract #AASLD2023AASLD_885;
Trial primary completion date: Oct 2023 --> Aug 2026 Background: Treatment of CHB with JNJ-3989 and NA
- | daplusiran/tomligisiran (GSK5637608) / GSK
Trial primary completion date: OCTOPUS-1: An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants (clinicaltrials.gov) - Oct 11, 2023
P2, N=37, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Background: Treatment of CHB with JNJ-3989 and NA Trial primary completion date: Sep 2023 --> Dec 2023
- | daplusiran/tomligisiran (GSK5637608) / GSK
Trial completion date: REEF-D: A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus (clinicaltrials.gov) - Sep 13, 2023
P2, N=52, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Sep 2023 --> Dec 2023 Trial completion date: Jul 2027 --> Aug 2026
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Biomarker, Trial primary completion date: INSIGHT: A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Jul 22, 2023
P2, N=24, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Jul 2027 --> Aug 2026 Trial primary completion date: Jul 2023 --> Feb 2023
- || JNJ-3989 / J&J, bersacapavir (JNJ-56136379) / J&J
P2b data, Journal: Efficacy and safety of the siRNA JNJ-73763989 and the capsid assembly modulator JNJ-56136379 (bersacapavir) with nucleos(t)ide analogues for the treatment of chronic hepatitis B virus infection (REEF-1): a multicentre, double-blind, active-controlled, randomised, phase 2b trial. (Pubmed Central) - Jul 14, 2023
P2b
Although treatment with JNJ-3989 led to a dose-dependent response for meeting nucleos(t)ide analogue-stopping criteria, it rarely led to HBsAg seroclearance. However, most patients treated with JNJ-3989 had clinically meaningful reductions in HBsAg that might contribute to a liver environment conducive to better immune control and, in turn, might improve the response to immune-modulating therapies.
- | daplusiran/tomligisiran (GSK5637608) / GSK
Trial completion date: REEF-D: A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus (clinicaltrials.gov) - Jun 29, 2023
P2, N=52, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
However, most patients treated with JNJ-3989 had clinically meaningful reductions in HBsAg that might contribute to a liver environment conducive to better immune control and, in turn, might improve the response to immune-modulating therapies. Trial completion date: Mar 2029 --> Jul 2027
- || daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Trial primary completion date: A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection (clinicaltrials.gov) - May 31, 2023
P2, N=54, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Mar 2029 --> Jul 2027 Trial primary completion date: Apr 2023 --> Sep 2023
- || daplusiran/tomligisiran (GSK5637608) / GSK
Trial completion date, Trial primary completion date: REEF-D: A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus (clinicaltrials.gov) - May 31, 2023
P2, N=52, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Apr 2023 --> Sep 2023 Trial completion date: Jul 2027 --> Mar 2029 | Trial primary completion date: Jun 2023 --> Oct 2023
- || daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Trial completion: PENGUIN: A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - May 17, 2023
P2, N=48, Completed, Sponsor: Janssen Research & Development, LLC
Trial completion date: Jul 2027 --> Mar 2029 | Trial primary completion date: Jun 2023 --> Oct 2023 Active, not recruiting --> Completed
- JNJ-3989 / J&J, bersacapavir (JNJ-56136379) / J&J
Association of post-treatment virologic relapse and biochemical flares with HBV serum biomarkers in long-term virologically suppressed HBeAg-negative patients stopping NA treatment: Exploratory analyses from the control arm of the REEF-2 study (Poster Area) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_2049;
P2b
In patients discontinuing NA treatment, the level of HBV DNA increases during viral relapse correlated with the peak levels of biochemical flares. EOT anti-HBc IgG levels ?300 IU/mL were strongly associated with the absence of high peak HBV DNA virologic relapse and high peak ALT flares ?10
- JNJ-3989 / J&J, bersacapavir (JNJ-56136379) / J&J
Intrahepatic characterization of virological and immunological markers in two distinct populations of chronic hepatitis B: baseline assessment of core liver and fine needle aspiration biopsies from the investigational INSIGHT study (Poster Area) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_1681;
P2
EOT anti-HBc IgG levels ?300 IU/mL were strongly associated with the absence of high peak HBV DNA virologic relapse and high peak ALT flares ?10 Intrahepatic characterization of virological and immunological markers in two distinct populations of chronic hepatitis B: pre-treatment core liver and fine needle aspiration biopsies from the investigational INSIGHT study Background and Aims: Treatment of chronic hepatitis B (CHB) patients with the siRNA JNJ- 73763989 (JNJ-3989) and nucleos(t)ide analogs (NAs)
- JNJ-3989 / J&J
Treatment with siRNA JNJ-73763989 plus nucleos(t)ide analogue (NA) decreases HBsAg and HDV RNA levels in patients with chronic hepatitis D (CHD): part 1 of the REEF-D study (Strauss 2-3) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_1490;
Clinically relevant ALT elevations were frequent and associated with increases in HDV RNA and led to treatment discontinuation. However, patients without ALT elevations generally had a continuous reduction of HDV RNA, 4/5 of whom met the primary efficacy endpoint.
- ||| daplusiran/tomligisiran (GSK5637608) / GSK
Enrollment change: REEF-D: A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus (clinicaltrials.gov) - Mar 15, 2023
P2, N=52, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
However, patients without ALT elevations generally had a continuous reduction of HDV RNA, 4/5 of whom met the primary efficacy endpoint. N=190 --> 52
- | daplusiran/tomligisiran (GSK5637608) / GSK
Enrollment closed: OCTOPUS-1: An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants (clinicaltrials.gov) - Feb 21, 2023
P2, N=37, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
N=190 --> 52 Recruiting --> Active, not recruiting
- || JNJ-3989 / J&J, bersacapavir (JNJ-56136379) / J&J
PK/PD data, Journal: Pharmacokinetics of Jnj-73763989 And Jnj-56136379 (Bersacapavir) In Participants With Moderate Hepatic Impairment. (Pubmed Central) - Feb 14, 2023
Overall, the plasma exposures of JNJ-73763989 and JNJ-56136379 were higher in participants with moderate hepatic impairment, but both were well tolerated. Further studies are needed to evaluate the effect of hepatic impairment under multiple dose administration.
- || daplusiran/tomligisiran (GSK5637608) / GSK
Enrollment closed: REEF-D: A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus (clinicaltrials.gov) - Jan 5, 2023
P2, N=190, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Further studies are needed to evaluate the effect of hepatic impairment under multiple dose administration. Recruiting --> Active, not recruiting
- || daplusiran/tomligisiran (GSK5637608) / GSK
Trial completion: A Study of JNJ-73763989 in Adult Participants With Renal Impairment (clinicaltrials.gov) - Dec 21, 2022
P1, N=29, Completed, Sponsor: Janssen Research & Development, LLC
Recruiting --> Active, not recruiting Recruiting --> Completed
- || JNJ-3989 / J&J
PK/PD data, Journal: Pharmacokinetics, Safety, and Tolerability of the siRNA JNJ-73763989 in Healthy Chinese Adult Participants. (Pubmed Central) - Nov 24, 2022
All treatment-emergent adverse events (AEs) were mild and resolved by study end, and no AEs or serious AEs resulted in premature study discontinuation or death. Overall, the pharmacokinetics of JNJ-73763989 in healthy Chinese participants were consistent with previous studies, and JNJ-73763989 was generally safe and well tolerated after a single dose.
- | daplusiran/tomligisiran (GSK5637608) / GSK, bersacapavir (JNJ-56136379) / J&J
Trial primary completion date: PENGUIN: A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Nov 23, 2022
P2, N=48, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Overall, the pharmacokinetics of JNJ-73763989 in healthy Chinese participants were consistent with previous studies, and JNJ-73763989 was generally safe and well tolerated after a single dose. Trial primary completion date: Oct 2022 --> May 2022
- || daplusiran/tomligisiran (GSK5637608) / GSK, JNJ-64300535 / J&J
Enrollment closed: OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Nov 23, 2022
P1b, N=24, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Oct 2022 --> May 2022 Recruiting --> Active, not recruiting
- JNJ-3989 / J&J, bersacapavir (JNJ-56136379) / J&J
EFFICACY AND SAFETY OF siRNA JNJ-73763989, CAPSID ASSEMBLY MODULATOR JNJ56136379, NUCLEOS(T)IDE ANALOG (NA), AND PEGYLATED INTERFERON ALPHA-2a (PEGIFNα2a) FOR TREATMENT OF CHRONIC HEPATITIS B (CHB): WEEK 24 RESULTS FROM THE PHASE 2 PENGUIN STUDY () - Nov 2, 2022 - Abstract #AASLD2022AASLD_2423;
P2
Addition of JNJ3989±JNJ-6379 and PegIFN-α2a to NA was generally safe and well tolerated in PENGUIN and resulted in profound HBsAg reduction and a high proportion of patients achieving HBsAg <100 IU/mL at W24. The additional antiviral effect of PegIFN-α2a in this regimen needs further evaluation.
- JNJ-3989 / J&J, bersacapavir (JNJ-56136379) / J&J
EFFICACY AND SAFETY OF COMBINATION TREATMENT WITH siRNA JNJ-73763989 AND CAPSID ASSEMBLY MODULATOR JNJ-56136379 (BERSACAPAVIR) IN HBEAG NEGATIVE VIROLOGICALLY SUPPRESSED CHRONIC HEPATITIS B PATIENTS: FOLLOW-UP WEEK 48 END OF STUDY RESULTS FROM REEF-2 (Ballroom ABC) - Nov 2, 2022 - Abstract #AASLD2022AASLD_2400;
P2b
Treatment with JNJ-3989 + JNJ-6379 + NA for 48 weeks was generally safe and well tolerated. After stopping all treatments, including NA, at W48, no patient achieved the primary endpoint, but lower HBsAg levels and greater HBV DNA suppression were observed for patients in the active arm after 48 weeks of FU.
- | daplusiran/tomligisiran (GSK5637608) / GSK, JNJ-64300535 / J&J
Trial primary completion date: OSPREY: A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - Oct 26, 2022
P1b, N=23, Recruiting, Sponsor: Janssen Research & Development, LLC
After stopping all treatments, including NA, at W48, no patient achieved the primary endpoint, but lower HBsAg levels and greater HBV DNA suppression were observed for patients in the active arm after 48 weeks of FU. Trial primary completion date: May 2023 --> Aug 2024
- JNJ-3989 / J&J
VIRAL SEQUENCE ANALYSIS OF NOT-CURRENTLY TREATED (NCT) CHRONIC HEPATITIS B (CHB) PATIENTS ENROLLED IN THE REEF-1 STUDY AND IMPACT OF BASELINE NUCLEOTIDE POLYMORPHISMS IN THE SMALL INTERFERING RNA (siRNA) JNJ-3989 TRIGGER TARGET REGIONS ON VIRAL ANTIGEN DECLINES () - Oct 23, 2022 - Abstract #AASLD2022AASLD_709;
P2b
Treatment of CHB patients with Q4W s.c. injections of JNJ-3989 (40-200mg) ± once-daily oral 250mg JNJ-6379 (CAM-N) in combination with nucleos(t)ide analogues for 48 weeks in the REEF-1 study (NCT03982186) led to dose-dependent reductions in hepatitis B virus (HBV) markers. Baseline nt polymorphisms in the JNJ-3989 S- and X-trigger target region were present in~10% of NCT patients and had no apparent impact on JNJ-3989 induced viral antigen declines.
- | JNJ-3989 / J&J
Clinical Trial,Phase II, Journal: Combination treatments including the small-interfering RNA JNJ-3989 induce rapid and sometimes prolonged viral responses in patients with CHB. (Pubmed Central) - Oct 20, 2022
P1/2
Baseline nt polymorphisms in the JNJ-3989 S- and X-trigger target region were present in~10% of NCT patients and had no apparent impact on JNJ-3989 induced viral antigen declines. JNJ-3989 plus an NA, with/without JNJ-6379, was well tolerated and resulted in HBsAg reductions up to 336 days after the last JNJ-3989 Q4W dose.
- || JNJ-3989 / J&J
PK/PD data, Preclinical, Journal: Plasma and liver pharmacokinetics of the GalNAc-siRNA JNJ-73763989 in rAAV-HBV infected mice. (Pubmed Central) - Sep 29, 2022
Significance Statement Pharmacokinetic modeling of JNJ-73763989 liver and plasma concentration-time data in mice indicated that the proportion of JNJ-3989 reaching the liver may be increased by administering lower SC doses compared to higher IV doses. Model-based simulations can be applied to optimize the dose and regimen combination.
- | daplusiran/tomligisiran (GSK5637608) / GSK
Trial primary completion date: A Study of JNJ-73763989 in Adult Participants With Renal Impairment (clinicaltrials.gov) - Aug 3, 2022
P1, N=32, Recruiting, Sponsor: Janssen Research & Development, LLC
Model-based simulations can be applied to optimize the dose and regimen combination. Trial primary completion date: Jun 2022 --> Sep 2022
- | daplusiran/tomligisiran (GSK5637608) / GSK
Trial completion date: OCTOPUS-1: An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants (clinicaltrials.gov) - Jul 29, 2022
P2, N=44, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Jun 2022 --> Sep 2022 Trial completion date: Aug 2024 --> May 2024