-Studies to evaluate safety and effects on viral kinetics in people with chronic genotype-1 hepatitis C-
-Data expected in second quarter of 2012 could enable initiation of interferon-free, nucleotide-based combination studies in the second half of 2012-
"These studies are an important step in our ongoing efforts to
strengthen our leadership position in hepatitis C by developing all-oral
regimens that could further improve the future treatment of this
The two Phase 1 studies announced today will be randomized, double-blind, placebo-controlled studies. The primary goals are to evaluate the safety and tolerability of single ascending doses of ALS-2200 and ALS-2158 in healthy volunteers and of multiple ascending doses in people with chronic genotype-1 hepatitis C. A secondary objective will be to evaluate the effects on viral kinetics of ALS-2200 and ALS-2158 during seven days of dosing in people with hepatitis C.
Dosing is now underway for the study of ALS-2200, and dosing is expected
to begin next week for the study of ALS-2158. Vertex and Alios BioPharma
expect to have complete data, including seven-day viral kinetic data,
from each trial in the second quarter of 2012, which could enable the
initiation of all-oral, interferon-free Phase 2 combination studies in
the second half of 2012. These Phase 2 studies are expected to evaluate
combination regimens of ALS-2200 or ALS-2158 with INCIVEK (telaprevir)
or VX-222, potential dual nucleotide regimens and other interferon-free
combination regimens that may also include ribavirin. INCIVEK is
About ALS-2200 and ALS-2158
ALS-2200 and ALS-2158 are highly potent pan-genotypic nucleotide
analogues that appear in in vitro and non-clinical studies to
have a high barrier to drug resistance and the potential to be dosed
orally once-daily. Both compounds are designed to inhibit the
replication of the hepatitis C virus by acting on the NS5B polymerase.
Each compound is structurally distinct and has its own unique mechanism
of action, which supports the potential for developing these compounds
together as a dual nucleotide regimen and as part of combination therapy
regimens, including regimens with INCIVEKTM (telaprevir) and
VX-222. Data from in vitro studies showed that both ALS-2200 and
ALS-2158 had a synergistic effect when combined together and with
INCIVEK and VX-222. Additionally, in those in vitro studies, both
compounds showed antiviral activity across all genotypes, or forms, of
the hepatitis C virus, including genotypes more prevalent outside of
Vertex gained worldwide rights to ALS-2200 and ALS-2158 through an
exclusive worldwide licensing agreement signed with
IMPORTANT SAFETY INFORMATION
INCIVEK™ (telaprevir) is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment. It is not known if INCIVEK is safe and effective in children under 18 years of age.
Important Safety Information
INCIVEK should always be taken in combination with peginterferon alfa and ribavirin. Ribavirin may cause birth defects or death of an unborn baby. Therefore, a patient should not take INCIVEK combination treatment if she is pregnant or may become pregnant, or if he is a man with a sexual partner who is pregnant. Patients must use two forms of effective birth control during treatment and for the 6 months after treatment with these medicines. Hormonal forms of birth control, including birth control pills, vaginal rings, implants or injections, may not work during treatment with INCIVEK.
INCIVEK and other medicines can affect each other and can also cause side effects that can be serious or life threatening. There are certain medicines patients cannot take with INCIVEK combination treatment. Patients should tell their healthcare providers about all the medicines they take, including prescription and non-prescription medicines, vitamins and herbal supplements.
INCIVEK can cause serious side effects including skin reactions, rash and anemia that can be severe. The most common side effects of INCIVEK include itching, nausea, diarrhea, vomiting, anal or rectal problems, taste changes and tiredness. There are other possible side effects of INCIVEK, and side effects associated with peginterferon alfa and ribavirin also apply to INCIVEK combination treatment. Patients should tell their healthcare providers about any side effect that bothers them or doesn't go away.
Please see full Prescribing Information for INCIVEK including the Medication Guide, available at www.INCIVEK.com.
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 However, approximately 60 percent of people do not achieve SVR,3,4,5 or viral cure,6 after treatment with 48 weeks of pegylated-interferon and ribavirin alone. If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.7,8
More than 170 million people worldwide are chronically infected with
hepatitis C.6 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, epilepsy and other life-threatening diseases.
Founded more than 20 years ago in
About Alios BioPharma
Alios BioPharma is a biotechnology company located in
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 Dr.
Mueller's statements in the second paragraph of this press release and
statements regarding (i) the expectation that Vertex will receive data
from two Phase 1 studies in the second quarter of 2012 that could enable
initiation of interferon-free, nucleotide-based combination studies in
the second half of 2012; (ii) the design, goals, objectives and expected
timing of receiving data from the Phase 1 studies; (iii) the possible
combination regimens that could be evaluated in Phase 2 studies and the
potential design of such studies; and (iv) the potential for developing
ALS-2200 and ALS-2158 together as a dual nucleotide regimen and as part
of other combination therapy regimens. 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,
the possibilities that the outcomes from the Phase 1 studies may not be
favorable, that the Company may not be able to successfully develop
ALS-2200 or ALS-2158, and the other risks listed under Risk Factors in
Vertex's annual report and quarterly reports filed with the
2 Pearlman BL and
3 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.
4 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.
5 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.
6 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
7 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).
8 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.
10 Pyenson B, Fitch K,
11 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact
of antiviral therapy for hepatitis C in
12 Davis GL, Alter MJ,
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