Drugs / LOMIBUVIR
LOMIBUVIR
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00958152 | Aug 2009 → Jan 2010 | hepatitis C virus infection | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00911963 | Apr 2009 → Sep 2012 | chronic hepatitis C virus infection | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT01581138 | Jul 2012 → Jun 2013 | chronic hepatitis C virus infection | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT01516918 | Feb 2012 → Sep 2013 | chronic hepatitis C virus infection | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT01080222 | Aug 2010 → Oct 2013 | chronic hepatitis C virus infection | Vertex Pharmaceuticals Incorporated | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2012-02-23 | Vertex Pharmaceuticals Incorporated | Results Vertex Announces 12-Week On-Treatment Data and SVR4 From Phase 2 Study of Interferon-Free (All-Oral) Treatment Regimen of INCIVEK®, VX-222 and Ribavirin in People with Genotype 1 Hepatitis C vrtx.com ↗
Nine of these 11 patients achieved SVR4 (undetectable hepatitis C virus four weeks after the end of all treatment). |
| 2011-11-05 | Vertex Pharmaceuticals Incorporated | Results Interim Data from Phase 2 Study Showed 93% of People with Hepatitis C Who Received a Total of 12 Weeks of a Combination Regimen Including INCIVEK™ (telaprevir) and VX-222 (400mg) Achieved a Viral Cure (SVR) vrtx.com ↗
Fifty percent (15/30) of patients who received the combination regimen including VX-222 (400mg) were eligible for a total of 12 weeks of treatment and 93 percent (14/15) of them achieved a viral cure (sustained viral response, or SVR). |
| 2011-07-26 | Vertex Pharmaceuticals Incorporated | Results Interim Data from Phase 2 Study of Combination Regimen Including VX-222 and INCIVEK™ Suggest Potential to Treat Genotype 1 Hepatitis C in as few as 12 Weeks and No More Than 24 Weeks vrtx.com ↗
The hepatitis C virus was undetectable in 100 percent (13/13) of these patients at the end of 24 weeks. |
| 2011-03-31 | Vertex Pharmaceuticals Incorporated | Results Interim Phase 2 Data Showed Rapid Viral Response to VX-222 in Combination with Telaprevir, Pegylated-Interferon and Ribavirin Among People With Hepatitis C vrtx.com ↗
Among those who received VX-222 (400 mg) in combination with telaprevir, pegylated-interferon and ribavirin, interim data showed that 90 percent (27/30) of them had undetectable hepatitis C virus at week 12. |
| 2010-12-21 | Vertex Pharmaceuticals Incorporated | Results Vertex Provides Update to Ongoing Phase 2 Study Evaluating Combinations of Telaprevir and VX-222 for the Treatment of Hepatitis C vrtx.com ↗
The company has discontinued the second two-drug treatment arm of telaprevir and VX-222 alone as a result of meeting a pre-defined stopping rule related to viral breakthrough. |
| 2010-10-25 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals Reports Third Quarter 2010 Financial Results and Highlights Progress in Hepatitis C and Cystic Fibrosis Development Programs vrtx.com ↗
The company will discontinue Arm A of this study as a result of patients meeting a pre-defined stopping rule related to viral breakthrough during the first four weeks of dosing. |
| 2010-04-15 | Vertex Pharmaceuticals Incorporated | Results Hepatitis C Virus Polymerase Inhibitor VX-222 Reduced Viral Levels Over Three Days in Phase 1b Trial vrtx.com ↗
Dosing with VX-222 for three days resulted in a greater than 3 log10 reduction in HCV RNA across all four of the VX-222 dosing groups. |
| 2009-04-21 | Vertex Pharmaceuticals Incorporated | Results Vertex Pharmaceuticals to Present Data at EASL Suggesting Telaprevir's Potential for Use in a Broad Range of HCV Patients and Highlighting the Company's Expanded STAT-C Portfolio vrtx.com ↗
No serious adverse events were observed in the study. |
All press releases naming this drug 12 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | LOMIBUVIR | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039503 ↗ |
| Known as | VCH-222 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00911963 ↗ |
| Known as | VX-222 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01516918 ↗ |
| Action | Inhibit | “selective nonnucleoside inhibitor of the hepatitis C virus (HCV) NS5B RNA-dependent RNA polymerase” PMID 24982088 ↗ Jun 2014 |
| Modality | Small molecule | “VX-222, a thiophene-2-carboxylic acid derivative” PMID 24982088 ↗ Jun 2014 |
| Route | Oral | “capsule, oral, 400 mg twice daily or 750 mg twice daily, 12 weeks” NCT00911963 ↗ |