-Two Phase 2 studies to evaluate once-daily combination of Vertex's investigational nucleotide analogue VX-135 and BMS' investigational NS5A replication complex inhibitor daclatasvir-
-Study in people with genotype 1 hepatitis C planned to begin in second quarter of 2013-
-Study in people with genotypes 1, 2 and 3 hepatitis C, including people with cirrhosis, planned for second half of 2013-
"With more than 170 million people infected worldwide, there is a
critical need for new hepatitis C medicines that can offer people
simpler and more tolerable treatment regimens that provide high cure
Clinical Development Plans for VX-135 with Daclatasvir
Under the terms of the agreement, Vertex will conduct two Phase 2 studies of VX-135 in combination with daclatasvir. The first study will enroll approximately 20 non-cirrhotic, treatment-naïve people with chronic genotype 1 HCV infection and is expected to begin in the second quarter of 2013. In the second half of 2013, Vertex plans to conduct a subsequent study in approximately 250 treatment-naïve people with chronic genotype 1, 2 or 3 HCV infection, including those with cirrhosis. Each of these studies is expected to evaluate safety, tolerability, pharmacokinetics and viral cure rates (SVR4 and SVR12) of multiple all-oral regimens of VX-135 and daclatasvir dosed once daily, pending regulatory discussions. Vertex will also conduct co-formulation activities to evaluate the potential for development of a once-daily fixed-dose combination regimen. Further clinical development activities beyond the Phase 2 studies are not covered as part of this agreement.
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. In people with genotype 1, treatment with a 200mg once-daily dose of VX-135 in a 7-day viral kinetic study was well-tolerated, with no discontinuations due to adverse events, and resulted in a 4.54 log10 median reduction from baseline in HCV RNA. Data from a 7-day viral kinetic study of VX-135 in people with genotypes 2, 3 and 4 were consistent with data observed in people with genotype 1 and have been submitted for presentation at a future medical meeting.
Vertex gained worldwide rights to ALS-2200, known as VX-135 in Phase 2
studies, through an exclusive licensing agreement signed with
Daclatasvir is an NS5A replication complex inhibitor that is being extensively studied as a key component of potential DAA-based hepatitis C treatment regimens. Studied in more than 4,100 patients to date, daclatasvir is in Phase 3 development.
Daclatasvir is part of a portfolio of investigational compounds with
different mechanisms of action that
About Hepatitis C
Hepatitis C is a serious liver infection 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 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 and statements regarding Vertex's expectations with
respect to the timing and structure of studies evaluating the
combination of VX-135 and daclatasvir. 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 the initiation of planned studies may be delayed or prevented, that
the outcomes of Vertex's planned clinical studies may not be favorable
and other risks listed under Risk Factors in Vertex's annual report and
quarterly reports filed with the
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.
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
VRTX — GEN
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