Drugs / VX-135
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | hepatitis C virus infection | 2013-07-25 | “Further evaluation of VX-135 in the U.S. is subject to resolution with the FDA regarding the partial clinical hold on VX-135.” vrtx.com ↗ “FDA places partial clinical hold on ongoing Phase 2 U.S. study of VX-135” vrtx.com ↗ “there is a partial clinical hold on VX-135 in the United States” vrtx.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT01842451 | Jun 2013 → May 2014 | chronic hepatitis C virus infection | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT01790100 | Feb 2013 → Jun 2014 | chronic hepatitis C virus infection | Alios Biopharma Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01726946 | Nov 2012 → Feb 2014 | chronic hepatitis C virus infection | Vertex Pharmaceuticals Incorporated | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2014-01-09 | Vertex Pharmaceuticals Incorporated | Results Vertex Announces Sustained Viral Response Rate (SVR4) Data from All-Oral Study of VX-135 in Combination with Daclatasvir in Hepatitis C vrtx.com ↗
In an intent-to-treat analysis, the sustained viral response rate four weeks after the completion of treatment (SVR4) was 83 percent (10 of 12) in treatment-naïve genotype 1 patients who received 200 mg of VX-135 in combination with daclatasvir. |
| 2013-10-29 | Vertex Pharmaceuticals Incorporated | Results Vertex Reports Third Quarter 2013 Financial Results and Provides Financial Outlook for 2014 vrtx.com ↗
The SVR4 rate was 10 percent. |
| 2013-07-25 | Vertex Pharmaceuticals Incorporated | Regulatory Vertex Provides Update on Ongoing All-Oral Studies of VX-135 in Hepatitis C vrtx.com ↗
The partial clinical hold prevents evaluation of a 200 mg dose of VX-135 in the U.S. study |
| 2013-04-23 | Vertex Pharmaceuticals Incorporated | Results ALS-2200 (VX-135) Viral Kinetic Study Shows Significant Reduction in HCV RNA in People with Genotype 1 Hepatitis C Virus Infection and Cirrhosis, and in People with Genotypes 2, 3 or 4 HCV Infection vrtx.com ↗
There was a median 4.08 log10 reduction in hepatitis C virus (HCV) RNA after seven days of dosing with 200 mg once daily in treatment-naïve people with genotype 1 chronic HCV infection and compensated cirrhosis. |
| 2012-11-10 | Vertex Pharmaceuticals Incorporated | Results Data from Viral Kinetic Study Showed Rapid Reduction of HCV RNA with ALS-2200 (VX-135), Vertex's Oral Nucleotide Analogue in Development for the Treatment of Hepatitis C vrtx.com ↗
There was a median 4.54 log10 reduction (range -3.81, -5.08) in hepatitis C virus (HCV) RNA after seven days of dosing with ALS-2200 (200 mg) once daily in people with genotype 1 chronic hepatitis C who were new to treatment (n=8). |
| 2012-10-01 | Vertex Pharmaceuticals Incorporated | Results Vertex Announces Presentation of New Data from Hepatitis C Development Program at AASLD Annual Meeting vrtx.com ↗
ALS-2200, a Novel Once-Daily Nucleotide HCV Polymerase Inhibitor, Demonstrates Potent Antiviral Activity over 7 Days in Treatment-Naïve Genotype 1 (GT1) Patients. |
| 2012-09-25 | Vertex Pharmaceuticals Incorporated | Results Vertex Announces New Data on ALS-2200 in People With Hepatitis C, Supporting Advancement into Phase 2 All-Oral Studies in 2012; Ends Development of ALS-2158 vrtx.com ↗
Similar to previously announced data from the monotherapy cohort, ALS-2200 was well-tolerated, no patients discontinued due to adverse events and there were no serious adverse events. |
All press releases naming this drug 11 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VX-135 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01842451 ↗ |
| Modality | Small molecule | — CHEMBL4783446 ↗ |
| Route | Oral | “orally administered VX-135 with ribavirin” NCT01790100 ↗ |