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- | inarigivir soproxil (SB 9200) / Gilead, Sino Biopharm
Journal: A Human Liver Organoid Screening Platform for DILI Risk Prediction. (Pubmed Central) - Apr 18, 2023
The high-throughput and liver-on-chip systems exhibit enhanced in
- || inarigivir soproxil (SB 9200) - Gilead, F / star
P2 data, Journal: A phase 2, open-label, randomized, multiple dose study evaluating Inarigivir in treatment-naïve patients with chronic hepatitis B. (Pubmed Central) - Oct 28, 2022
12-week Inarigivir up to 200 mg dose was associated with reduction of HBV DNA, HBV RNA and antigen levels. A trend for greater HBsAg reduction was observed in Inarigivir pre-treated patients after switching to tenofovir.
- | inarigivir soproxil (SB 9200) - Gilead, F / star
Journal, IO biomarker: Activation of DDX58/RIG‑I suppresses the growth of tumor cells by inhibiting STAT3/CSE signaling in colon cancer. (Pubmed Central) - Aug 26, 2022
On the whole, the present study demonstrates that DDX58/RIG‑I affects the proliferation of tumor cells by regulating STAT3/CSE signaling in colon cancer. The findings presented herein suggest that DDX58/RIG‑I activation may be an effective treatment strategy, and DDX58/RIG‑I agonists may be potential therapeutic candidates for colon cancer.
- ||||| inarigivir soproxil (SB 9200) - Gilead, F / star, Vemlidy (tenofovir alafenamide) / Gilead
Trial termination: Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - Apr 4, 2022
P2, N=123, Terminated, Sponsor: Gilead Sciences
The findings presented herein suggest that DDX58/RIG‑I activation may be an effective treatment strategy, and DDX58/RIG‑I agonists may be potential therapeutic candidates for colon cancer. Completed --> Terminated; Study was terminated due to sponsor's decision to not pursue further development of inarigivir soproxil in chronic hepatitis B.
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] New Agents for Treatment of HBV Infection: Targeting the Immune System () - Aug 19, 2021 - Abstract #APDW2021APDW_174;
A phase 2 study in untreated patients failed to show any significant HBsAg decline with 12-week course of vesatolimod and tenofovir disoproxil fumarate (TDF) combination...Phase 2 study of selgantolimod in combination with nucleos(t)ide analogue in virologically suppressed patients showed mild decline of HBsAg in up to 20% of patients after 24 weeks of treatment...Phase 1 study on inarigivir showed dose-dependent HBV DNA reduction and HBV RNA reduction after 12-week treatment, and 26% of patients had HBsAg reduction of >0.5 log IU/ml...A phase 1 study using low dose nivolumab, a monoclonal antibody blocking PD1, has shown HBsAg decline in virologically suppressed patients with a single patients clearing HBsAg. Newer formula of PD1 and PD L1 blockade using GalNac targeting are under development for liver-specific therapeutic effect against HBV.
- | inarigivir soproxil (SB 9200) - Gilead, F / star
Preclinical, Journal: NOD2/RIG-I Activating Inarigivir Adjuvant Enhances the Efficacy of BCG Vaccine Against Tuberculosis in Mice. (Pubmed Central) - Jun 26, 2021
Consistent with an increase in immunogenicity of adjuvant treated APCs, the Inarigivir-BCG vaccine combination induced robust protection against tuberculosis in a mouse model of MTB infection, decreasing the lung burden of MTB by 1-log10 more than that afforded by BCG vaccine alone. The Inarigivir-BCG combination was also more efficacious than a muramyl-dipeptide-BCG vaccine combination against tuberculosis in mice, generating better memory T cell responses supporting its novel adjuvant potential for the BCG vaccine.
- inarigivir soproxil (SB 9200) - Gilead, F / star, Vemlidy (tenofovir alafenamide) / Gilead
[VIRTUAL] Safety, efficacy, & pharmacodynamic (PD) activity of 12 weeks treatment with oral RIG-I agonist, inarigivir (IRIG), plus 48 weeks of tenofovir alafenamide in adult patients with chronic hepatitis B: a phase 2 collaboration study (Poster area) - Apr 9, 2021 - Abstract #EASLILC2021EASL_ILC_1168;
IRIG was generally safe and well tolerated at doses ≤400 mg for 12WK. IRIG development has been discontinued due to IRIG-related hepatoxicity.
- ||| inarigivir soproxil (SB 9200) - Gilead, F / star, Vemlidy (tenofovir alafenamide) / Gilead
Trial completion, Trial completion date: Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - Feb 8, 2021
P2, N=123, Completed, Sponsor: Gilead Sciences
IRIG development has been discontinued due to IRIG-related hepatoxicity. Active, not recruiting --> Completed | Trial completion date: May 2021 --> Jan 2021
- || Clinical, Review, Journal: Review article: clinical pharmacology of current and investigational hepatitis B virus therapies. (Pubmed Central) - Jul 29, 2020
Increasing the potential for HBsAg loss may result in more patients achieving functional cure. However, many knowledge gaps remain such as pharmacokinetics in those with HBV, cirrhosis and renal impairment but also the interaction potential between investigational therapies, risk-benefit profiles, and potential for drug interactions with medications used to treat comorbidities associated with aging.
- inarigivir soproxil (SB 9200) / Spring Bank, Gilead
[VIRTUAL] Liver toxicity in the Phase 2 Catalyst 206 trial of Inarigivir 400mg daily added to a nucleoside in HBV EAg negative patients (Poster Area) - Jul 29, 2020 - Abstract #EASLILCI2020EASL-ILC-I-2045;
Further studies are ongoing to identify causality and mechanisms. These findings have implications for trial design in HBV ‘cure’ studies and liver safety parameter monitoring.
- ||||| inarigivir soproxil (SB 9200) - Gilead, F / star
Trial termination: Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic, Hepatitis B e Antigen-negative Subjects Infected With HBV Virus and Receiving or Stopping Treatment With a NUC Inhibitor (clinicaltrials.gov) - Jul 22, 2020
P2, N=64, Terminated, Sponsor: Spring Bank Pharmaceuticals, Inc.
These findings have implications for trial design in HBV ‘cure’ studies and liver safety parameter monitoring. Active, not recruiting --> Terminated; Safety
- inarigivir soproxil (SB 9200) / Spring Bank, Gilead
[VIRTUAL] Mechanism of action studies of inarigivir, a novel immunomodulator against chronic hepatitis B (Poster Area) - May 30, 2020 - Abstract #EASLILCI2020EASL-ILC-I-1774;
Active, not recruiting --> Terminated; Safety The in vitro and in vivo studies support the MOA of Inarigivir involving the activation of hRIG-I to produce IFNs and cytokines and mediate antiviral activity in CHB patients.
- || inarigivir soproxil (SB 9200) - Gilead, F / star
Trial completion date, Trial primary completion date: Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic, Hepatitis B e Antigen-negative Subjects Infected With HBV Virus and Receiving or Stopping Treatment With a NUC Inhibitor (clinicaltrials.gov) - Apr 29, 2020
P2, N=60, Active, not recruiting, Sponsor: Spring Bank Pharmaceuticals, Inc.
The in vitro and in vivo studies support the MOA of Inarigivir involving the activation of hRIG-I to produce IFNs and cytokines and mediate antiviral activity in CHB patients. Trial completion date: Jun 2022 --> Jun 2020 | Trial primary completion date: Jun 2022 --> Jun 2020
- | inarigivir soproxil (SB 9200) - Gilead, F / star
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Evaluating the Effects of Inarigivir on Immune Response and Viral Markers in Chronic Hepatitis B Patients (clinicaltrials.gov) - Apr 29, 2020
P2, N=8, Terminated, Sponsor: Spring Bank Pharmaceuticals, Inc.
Trial completion date: Jun 2022 --> Jun 2020 | Trial primary completion date: Jun 2022 --> Jun 2020 N=16 --> 8 | Trial completion date: Nov 2020 --> Dec 2019 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2020 --> Dec 2019; Study was halted due to suspected liver injury in another study with Inarigavir
- | inarigivir soproxil (SB 9200) / Gilead, Sino Biopharm
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic Treatment Naive Subjects Infected With Hepatitis B Virus (clinicaltrials.gov) - Apr 28, 2020
P2, N=5, Terminated, Sponsor: Spring Bank Pharmaceuticals, Inc.
N=16 --> 8 | Trial completion date: Nov 2020 --> Dec 2019 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2020 --> Dec 2019; Study was halted due to suspected liver injury in another study with Inarigavir N=60 --> 5 | Trial completion date: Aug 2022 --> Apr 2020 | Active, not recruiting --> Terminated | Trial primary completion date: Aug 2022 --> Apr 2020; Evidence of liver injury in a separate Inarigavir study
- ||| inarigivir soproxil (SB 9200) - Gilead, F / star
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: ACHIEVE: A Study Evaluating the Safety, Pharmacokinetics, and Antiviral Efficacy of SB 9200 in Subjects Infected With Chronic HBV (clinicaltrials.gov) - Feb 11, 2020
P2, N=80, Completed, Sponsor: Spring Bank Pharmaceuticals, Inc.
N=60 --> 5 | Trial completion date: Aug 2022 --> Apr 2020 | Active, not recruiting --> Terminated | Trial primary completion date: Aug 2022 --> Apr 2020; Evidence of liver injury in a separate Inarigavir study Active, not recruiting --> Completed | N=200 --> 80 | Trial completion date: Jul 2021 --> Feb 2020 | Trial primary completion date: Jul 2021 --> Feb 2020
- inarigivir soproxil (SB 9200) / Spring Bank, Gilead
Mechanism of action studies of inarigivir, a novel immunomodulator against chronic hepatitis b (Poster Area) - Feb 2, 2020 - Abstract #EASLILC2020EASL-ILC_1851;
- || inarigivir soproxil (SB 9200) - Gilead, F / star
Enrollment closed: Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic, Hepatitis B e Antigen-negative Subjects Infected With HBV Virus and Receiving or Stopping Treatment With a NUC Inhibitor (clinicaltrials.gov) - Jan 27, 2020
P2, N=60, Active, not recruiting, Sponsor: Spring Bank Pharmaceuticals, Inc.
Active, not recruiting --> Completed | N=200 --> 80 | Trial completion date: Jul 2021 --> Feb 2020 | Trial primary completion date: Jul 2021 --> Feb 2020 Recruiting --> Active, not recruiting
- | inarigivir soproxil (SB 9200) - Gilead, F / star
Enrollment closed: Evaluating the Effects of Inarigivir on Immune Response and Viral Markers in Chronic Hepatitis B Patients (clinicaltrials.gov) - Jan 27, 2020
P2, N=16, Active, not recruiting, Sponsor: Spring Bank Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- || inarigivir soproxil (SB 9200) / Gilead, Sino Biopharm
Enrollment closed: Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic Treatment Naive Subjects Infected With Hepatitis B Virus (clinicaltrials.gov) - Jan 27, 2020
P2, N=60, Active, not recruiting, Sponsor: Spring Bank Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- ||| inarigivir soproxil (SB 9200) / Spring Bank, Gilead
Clinical: $SBPH Stops Dosing and Enrollment in All Inarigivir Studies in Subjects With Chronic HBV https://t.co/EmFPGOnOwv (Twitter) - Dec 26, 2019
- || inarigivir soproxil (SB 9200) - Gilead, F / star, Vemlidy (tenofovir alafenamide) / Gilead
Enrollment closed: Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - Nov 29, 2019
P2, N=123, Active, not recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- | inarigivir soproxil (SB 9200) / Gilead, Sino Biopharm
Enrollment open: Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic Treatment Naive Subjects Infected With Hepatitis B Virus (clinicaltrials.gov) - Oct 15, 2019
P2, N=60, Recruiting, Sponsor: Spring Bank Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | inarigivir soproxil (SB 9200) - Gilead, F / star, Vemlidy (tenofovir alafenamide) / Gilead
Trial completion date: Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - Sep 6, 2019
P2, N=120, Recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting Trial completion date: Dec 2020 --> May 2021
- | inarigivir soproxil (SB 9200) / Gilead, Sino Biopharm
New P2 trial: Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic Treatment Naive Subjects Infected With Hepatitis B Virus (clinicaltrials.gov) - Aug 15, 2019
P2, N=60, Not yet recruiting, Sponsor: Spring Bank Pharmaceuticals, Inc.
- | inarigivir soproxil (SB 9200) - Gilead, F / star
New P2 trial: Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic, Hepatitis B e Antigen-negative Subjects Infected With HBV Virus and Receiving or Stopping Treatment With a NUC Inhibitor (clinicaltrials.gov) - Jul 17, 2019
P2, N=60, Recruiting, Sponsor: Spring Bank Pharmaceuticals, Inc.
- ||| inarigivir soproxil (SB 9200) - Gilead, F / star, Vemlidy (tenofovir alafenamide) / Gilead
Enrollment change, Trial completion date, Trial primary completion date: Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - Jun 19, 2019
P2, N=120, Recruiting, Sponsor: Gilead Sciences
Trial completion date: Dec 2020 --> May 2021 N=90 --> 120 | Trial completion date: Jun 2020 --> Dec 2020 | Trial primary completion date: Jul 2019 --> Apr 2020
- || inarigivir soproxil (SB 9200) - Gilead, F / star
New P2 trial: Evaluating the Effects of Inarigivir on Immune Response and Viral Markers in Chronic Hepatitis B Patients (clinicaltrials.gov) - Apr 30, 2019
P2, N=16, Recruiting, Sponsor: Spring Bank Pharmaceuticals, Inc.
- || inarigivir soproxil (SB 9200) - Gilead, F / star
Enrollment closed: ACHIEVE: A Study Evaluating the Safety, Pharmacokinetics, and Antiviral Efficacy of SB 9200 in Subjects Infected With Chronic HBV (clinicaltrials.gov) - Apr 26, 2019
P2, N=200, Active, not recruiting, Sponsor: Spring Bank Pharmaceuticals, Inc.
N=90 --> 120 | Trial completion date: Jun 2020 --> Dec 2020 | Trial primary completion date: Jul 2019 --> Apr 2020 Recruiting --> Active, not recruiting
- | inarigivir soproxil (SB 9200) / Spring Bank
$sbph #ilc19 inarigivir presentation coming up in 90min. myQ: better than ifns? (Twitter) - Apr 12, 2019
- || inarigivir soproxil (SB 9200) - Gilead, F / star, Vemlidy (tenofovir alafenamide) / Gilead
Trial primary completion date: Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - Jan 10, 2019
P2, N=90, Recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting Trial primary completion date: Dec 2018 --> Jul 2019
- | inarigivir soproxil (SB 9200) / Gilead, Sino Biopharm
Trial completion: A Fixed-Sequence, Drug-Drug Interaction Study Between Multiple Oral Doses of Inarigivir Soproxil and a Single Oral Dose of Midazolam in Healthy Subjects (clinicaltrials.gov) - Sep 6, 2018
P1, N=16, Completed, Sponsor: Spring Bank Pharmaceuticals, Inc.
Trial primary completion date: Dec 2018 --> Jul 2019 Not yet recruiting --> Completed
- |||| inarigivir soproxil (SB 9200) - Gilead, F / star, Vemlidy (tenofovir alafenamide) / Gilead
New P2 trial: Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - Jul 16, 2018
P2, N=90, Recruiting, Sponsor: Gilead Sciences
- | inarigivir soproxil (SB 9200) - Gilead, F / star, Vemlidy (tenofovir alafenamide) / Gilead
Trial completion date: Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - May 4, 2018
P2, N=70, Recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Completed Trial completion date: Mar 2020 --> Jun 2020
- ||| inarigivir soproxil (SB 9200) - Gilead, F / star
Enrollment change, Trial completion date, Trial primary completion date: ACHIEVE: A Study Evaluating the Safety, Pharmacokinetics, and Antiviral Efficacy of SB 9200 in Subjects Infected With Chronic HBV (clinicaltrials.gov) - Apr 18, 2018
P2, N=200, Recruiting, Sponsor: Spring Bank Pharmaceuticals, Inc.
Trial completion date: Mar 2020 --> Jun 2020 N=300 --> 200 | Trial completion date: Dec 2017 --> Jul 2021 | Trial primary completion date: Dec 2017 --> Jul 2021
- | inarigivir soproxil (SB 9200) / Gilead, Sino Biopharm
New P1 trial: A Fixed-Sequence, Drug-Drug Interaction Study Between Multiple Oral Doses of Inarigivir Soproxil and a Single Oral Dose of Midazolam in Healthy Subjects (clinicaltrials.gov) - Apr 9, 2018
P1, N=16, Not yet recruiting, Sponsor: Spring Bank Pharmaceuticals, Inc.
- |||| inarigivir soproxil (SB 9200) - Gilead, F / star, Vemlidy (tenofovir alafenamide) / Gilead
Enrollment open: Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - Mar 12, 2018
P2, N=70, Recruiting, Sponsor: Gilead Sciences
N=300 --> 200 | Trial completion date: Dec 2017 --> Jul 2021 | Trial primary completion date: Dec 2017 --> Jul 2021 Not yet recruiting --> Recruiting
- ||||| inarigivir soproxil (SB 9200) - Gilead, F / star, Vemlidy (tenofovir alafenamide) / Gilead
New P2 trial: Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB) (clinicaltrials.gov) - Feb 15, 2018
P2, N=70, Not yet recruiting, Sponsor: Gilead Sciences
- inarigivir soproxil (SB 9200) - Gilead, F / star
Enrollment open: ACHIEVE: A Study Evaluating the Safety, Pharmacokinetics, and Antiviral Efficacy of SB 9200 in Subjects Infected With Chronic HBV (clinicaltrials.gov) - Jun 24, 2016
P2, N=300, Recruiting, Sponsor: Spring Bank Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | inarigivir soproxil (SB 9200) - Gilead, F / star
New P2 trial: ACHIEVE: A Study Evaluating the Safety, Pharmacokinetics, and Antiviral Efficacy of SB 9200 in Subjects Infected With Chronic HBV (clinicaltrials.gov) - Apr 26, 2016
P2, N=300, Not yet recruiting, Sponsor: Spring Bank Pharmaceuticals, Inc.
- inarigivir soproxil (SB 9200) - Gilead, F / star
P1 data, Enrollment change: A Multiple Ascending Dose Phase I Study of SB 9200 in Treatment Naïve Adults With Chronic Hepatitis C Infection (clinicaltrials.gov) - Dec 10, 2014
P1, N=37, Completed, Sponsor: INC Research
Not yet recruiting --> Recruiting N=64 --> 37
- inarigivir soproxil (SB 9200) - Gilead, F / star
Trial completion, P1 data, Trial primary completion date: A Multiple Ascending Dose Phase I Study of SB 9200 in Treatment Naïve Adults With Chronic Hepatitis C Infection (clinicaltrials.gov) - Aug 29, 2014
P1, N=64, Completed, Sponsor: INC Research
N=64 --> 37 Recruiting --> Completed | Trial primary completion date: Jan 2014 --> Aug 2014
- inarigivir soproxil (SB 9200) - Gilead, F / star
Enrollment open, P1 data: A Multiple Ascending Dose Phase I Study of SB 9200 in Treatment Naïve Adults With Chronic Hepatitis C Infection (clinicaltrials.gov) - Apr 24, 2013
P1, N=64, Recruiting, Sponsor: INC Research
Recruiting --> Completed | Trial primary completion date: Jan 2014 --> Aug 2014 Not yet recruiting --> Recruiting
- inarigivir soproxil (SB 9200) - Gilead, F / star
New P1 trial, P1 data: A Multiple Ascending Dose Phase I Study of SB 9200 in Treatment Naïve Adults With Chronic Hepatitis C Infection (clinicaltrials.gov) - Feb 28, 2013
P1, N=64, Recruiting, Sponsor: INC Research