Drugs / ABI-H2158
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04142762 | Oct 2019 → Jan 2020 | chronic hepatitis B virus infection | Assembly Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT04083716 | Sep → Oct 2019 | chronic hepatitis B virus infection | Assembly Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT03714152 | Nov 2018 → Nov 2020 | chronic hepatitis B virus infection | Assembly Biosciences | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04398134 | Aug 2020 → Oct 2021 | chronic hepatitis B virus infection | Assembly Biosciences | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2021-09-01 | Assembly Biosciences | Results Assembly Bio Announces Decision to Discontinue Clinical Development of ABI-H2158 assemblybio.com ↗ |
| 2021-06-09 | Assembly Biosciences | Results Assembly Biosciences to Present Data from HBV Core Inhibitor Programs at The International Liver Congress™ EASL 2021 assemblybio.com ↗
Second generation hepatitis B virus core inhibitors ABI-H2158 and ABI-H3733 have enhanced potency and target coverage for both antiviral inhibition and covalently closed circular DNA establishment activities |
| 2020-08-28 | Assembly Biosciences | Results Clinical Data from Assembly Biosciences’ HBV Core Inhibitors Presented at The Digital International Liver CongressTM EASL 2020 assemblybio.com ↗
At the 300-mg dose, the mean decline from baseline to day 15 in HBV DNA and pgRNA levels were 2.5 log 10 IU/mL and 2.3 log 10 U/mL, respectively. |
| 2020-07-09 | Assembly Biosciences | Regulatory Assembly Biosciences Announces FDA Fast Track Designation Granted to ABI-H2158 for the Treatment of Chronic Hepatitis B Virus Infection assemblybio.com ↗ |
| 2019-10-16 | Assembly Biosciences | Results Safety and Antiviral Activity of Assembly Biosciences’ First and Second Generation Core Inhibitor Candidates In the Treatment of Chronic Hepatitis B to be Featured in a Late Breaking Session at AASLD assemblybio.com ↗
Potent antiviral activity observed in first cohort of HBeAg+ patients treated in 14-day monotherapy study of ABI-H2158 |
| 2019-04-11 | Assembly Biosciences | Results Assembly Biosciences Presents Data Highlighting Next-Generation HBV Core Protein Inhibitors at EASL 2019 assemblybio.com ↗
Phase 1a study of ABI-H2158 demonstrated safety, tolerability and achievement of target liver concentrations |
| 2017-10-02 | Assembly Biosciences | Results Assembly Biosciences Announces 2017 AASLD Presentations assemblybio.com ↗
The poster presents data showing that Assembly's next generation CpAMs, including our recently nominated clinical candidate ABI-H2158, exhibit enhanced inhibitory potency against HBV replication and cccDNA generation, and maintain favorable drug properties. |
All press releases naming this drug 8 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ABI-H2158 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04142762 ↗ |
| Route | Oral | “ABI-H2158 in varying doses of tablets by mouth without and with food for 1 day or 10 days” NCT03714152 ↗ |