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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
- After seven days of once-daily dosing with 200 mg of ALS-2200, genotype 1 patients with cirrhosis had a median 4.08 log10 reduction in HCV RNA; among people with genotypes 3 or 4, there was a median 4.65 log10 reduction in HCV RNA -
- Data are consistent with previously reported ALS-2200 results in people with genotype 1 HCV infection -
- ALS-2200 was well-tolerated, with no discontinuations due to adverse events-
These data support Vertex's recently announced non-exclusive agreement with Bristol-Myers Squibb Company to conduct Phase 2 studies of once-daily all-oral treatment regimens containing VX-135 and Bristol-Myers Squibb's NS5A replication complex inhibitor daclatasvir for the treatment of hepatitis C. As part of the agreement, Vertex plans to conduct two Phase 2 studies of the combination, including an initial study in treatment-naïve people with genotype 1 HCV infection planned for the second quarter of 2013. Vertex plans to begin a subsequent study in treatment-naïve people infected with genotype 1, 2 or 3 HCV, including those with cirrhosis, in the second half of 2013, pending data from the initial study.
"The viral kinetic data announced to date show the potential for VX-135
to be the backbone of all-oral treatment regimens," said
Results of seven-day viral kinetic evaluations of ALS-2200 in treatment-naïve people with chronic HCV infection are included in the following table:
Median Change From
HCV RNA Levels
|Genotypes 1, 3 and 4||(5.70, 7.35)||(-0.47, 0.66)|
|200 mg monotherapy||6.18||-4.54||4 (50)|
|Genotype 1||(5.66, 6.72)||(-3.81, -5.08)|
|200 mg + ribavirin||6.21||-4.18||5 (63)|
|Genotype 1||(5.14, 7.41)||(-3.62, -5.20)|
|200 mg monotherapy||6.64||-4.65||5 (63)|
|Genotypes 3 and 4||(5.59, 6.93)||(-4.05, -5.30)|
|Genotype 1||(6.36, 6.47)||(0.03, 0.10)|
|(n = 2)|
|200 mg monotherapy||6.53||-4.08||1 (13)|
|Genotype 1||(6.08, 7.22)||(-2.91, -4.87)|
|(n = 8)|
*Roche COBAS® Taqman® HCV Assay v2.0 (LLOQ = 25 IU/mL)
**Prior to a protocol amendment, one person with genotype 2 HCV infection received 100 mg of ALS-2200 once daily for seven days, and had a 5.04 log10 reduction in HCV RNA after seven days of dosing.
About VX-135 (ALS-2200)
Vertex has multiple ongoing and planned studies of VX-135 as part of all-oral treatment regimens, including a study in combination with ribavirin and studies with other direct-acting antivirals. Vertex plans to begin pivotal development of VX-135 as part of all-oral treatment regimens in 2014, pending data from these studies. The first Phase 2 data for VX-135 as part of an all-oral regimen are expected in the second half of 2013.
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.
ALS-2200 has shown pangenotypic activity in vitro. Vertex gained
worldwide rights to ALS-2200 through an exclusive licensing agreement
About Hepatitis C
Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1 Unlike HIV and hepatitis B virus, chronic hepatitis C can be cured.2 If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.3,4
More than 170 million people worldwide are chronically infected with
hepatitis C.5 In
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies 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 hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases.
Founded more than 20 years ago in
Vertex's press releases are available at www.vrtx.com.
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, the statements of Dr. Kauffman in the third paragraph of
this press release, and statements regarding (i) the timing and
structure of multiple Phase 2 studies exploring all-oral treatment
regimens that include VX-135 in combination with ribavirin and/or other
direct-acting antivirals, including daclatasvir; (ii) Vertex's plans to
begin pivotal development of VX-135 as part of all-oral treatment
regimens in 2014, pending data from this studies and (iii) the first
Phase 2 data for VX-135 as part of an all-oral regimen being expected in
the second half of 2013. While the company 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 the
Phase 2 studies of VX-135 may be delayed or prevented, outcomes from any
future studies of VX-135 may not be favorable and the other risks listed
under Risk Factors in Vertex's annual report and quarterly reports filed
2 Pearlman BL and
3 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
4 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
5 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
6 Chak, E, et. al.
8 Smith, BD, et al. Hepatitis C Virus Antibody Prevalence,
Correlates and Predictors among Persons Born from 1945 through 1965,
9 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact
of antiviral therapy for hepatitis C in
10 Ly KN, et al. The Increasing Burden of Mortality From
Viral Hepatitis in
11 Pyenson B, Fitch K, and
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