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Vertex Announces Sustained Viral Response Rate (SVR4) Data from All-Oral Study of VX-135 in Combination with Daclatasvir in Hepatitis C
"We are encouraged by these initial Phase 2a data for VX-135 in
combination with another direct acting antiviral medicine," said
About the Phase 2a Study
The data announced today are from the first two cohorts of an open-label Phase 2a study of VX-135 in combination with daclatasvir. The initial two cohorts of the study evaluated 100 mg and 200 mg once-daily doses of VX-135 in combination with daclatasvir once daily (60 mg) for 12 weeks of total treatment. Twenty-three people with chronic genotype 1 hepatitis C who were new to treatment (treatment-naïve) and did not have liver cirrhosis were enrolled in these cohorts. More than 75 percent of all patients enrolled had genotype 1a HCV. The majority of adverse events observed in the study were mild. The most common adverse events observed in greater than 10 percent of patients across the study were fatigue, headache and nausea. Safety and efficacy data for the two arms of the study are provided below:
- 200 mg of VX-135 in Combination with Daclatasvir (60 mg): In an intent-to-treat analysis, 58 percent (7 of 12) of patients had undetectable HCV RNA after 4 weeks of treatment and 83 percent (10 of 12) of patients had undetectable HCV RNA four weeks after the completion of treatment (SVR4). One patient in this arm experienced a serious adverse event of vomiting/nausea, discontinued treatment after the first dose and did not acheive SVR4. The 11 other patients in this arm completed 12 weeks of treatment, and 91 percent (10 of 11) achieved SVR4. One patient relapsed during the follow-up period and did not achieve SVR4.
- 100 mg of VX-135 in Combination with Daclatasvir (60 mg): In an intent-to-treat analysis, 73 percent (8 of 11) of patients achieved undetectable HCV RNA after 4 weeks of treatment and 73 percent (8 of 11) of patients had undetectable HCV RNA four weeks after the completion of treatment (SVR4). Two patients in this arm experienced viral breakthrough while receiving the combination regimen, and one patient relapsed during the follow-up period.
Vertex expects to submit these data for presentation at a medical meeting in 2014.
VX-135 is a uridine nucleotide analogue pro-drug designed to inhibit the
replication of the hepatitis C virus by acting on the NS5B polymerase.
Vertex gained worldwide rights to ALS-2200, known as VX-135 in Phase 2
studies, through an exclusive licensing agreement signed with
Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of cystic fibrosis, hepatitis C, rheumatoid arthritis and other life-threatening diseases. In addition to our clinical development programs, Vertex has more than a dozen ongoing preclinical programs aimed at other serious and life-threatening diseases.
Founded in 1989 in
Vertex Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, including, without
limitation, Dr. Kauffman's statements in the second paragraph of the
press release. While Vertex believes the forward-looking statements
contained in this press release are accurate, there are a number of
factors that could cause actual events or results to differ materially
from those indicated by such forward-looking statements. Those risks and
uncertainties include, among other things, that there is a partial
clinical hold on VX-135 in
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