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Vertex Announces 12-Week On-Treatment Data and SVR4 From Phase 2 Study of Interferon-Free (All-Oral) Treatment Regimen of INCIVEK®, VX-222 and Ribavirin in People with Genotype 1 Hepatitis C
- Company plans to start Phase 2b study in Q3 2012 to evaluate this interferon-free combination regimen in a total treatment duration as short as 12 weeks -
- Vertex also announces the advancement of its broad portfolio of direct acting antivirals, including its two structurally-distinct nucleotide polymerase inhibitors -
ZENITH was designed with strict response-guided criteria that determined whether a patient was eligible to stop all treatment at 12 weeks. Eleven patients met the criteria of having undetectable hepatitis C virus at weeks two and eight of treatment and were therefore eligible to stop all treatment at 12 weeks. Nine of these 11 patients achieved SVR4 (undetectable hepatitis C virus four weeks after the end of all treatment). Data from ZENITH have been submitted for presentation at a medical meeting in the first half of 2012.
Additional interim results from two interferon-free arms of ZENITH announced today showed:
Arm E† (n=23)
Arm F‡ (n=23)
Arms E & F
|6/23 (26%)||7/23 (30%)||13/46 (28%)|
|< LLOQ**||21/23 (91%)||16/23 (70%)||37/46 (80%)|
|Week 4 (RVR)||
|21/23 (91%)||13/23 (57%)||34/46 (74%)|
|< LLOQ||21/23 (91%)||21/23 (91%)||42/46 (91%)|
|Week 12 (cEVR)||
|19/23 (83%)||19/23 (83%)||38/46 (83%)|
|< LLOQ||19/23 (83%)||19/23 (83%)||38/46 (83%)|
|5/5||Data not yet available||Data not yet available|
† 19 patients completed 12 weeks of treatment: Two
patients discontinued due to adverse events. One patient had
virologic failure. One patient withdrew consent.
‡ 20 patients completed 12 weeks of treatment. Two patients had virologic failure. One patient was lost to follow up.
* HCV RNA < 10 IU/mL
** HCV RNA < 25 IU/mL
^ The two patients who did not achieve SVR4 relapsed during the post-treatment follow-up period.
The three drug regimen was generally well-tolerated. The majority of adverse events were reported as mild. There were no cases of moderate or severe rash and no discontinuations due to rash or anemia in the interferon-free study arms. There were two discontinuations due to adverse events in the genotype 1b arm of the study.
Vertex Advances INCIVEK, VX-222 and Ribavirin Combination Regimen
Based on these data, and pending discussions with regulatory agencies,
the company intends to pursue a Phase 2b study evaluating multiple
interferon-free combination regimens of INCIVEK, VX-222 and ribavirin
with total treatment durations as short as 12 weeks in people with
genotype 1 (1a and 1b) hepatitis C who are new to treatment. The new
study will not use response-guided treatment criteria. If successful,
data from this study will be used to design a Phase 3 program with the
goal of submitting a New Drug Application (NDA) to the
"Since its approval INCIVEK has been used to treat tens of thousands
people with hepatitis C and we're committed to further improving the
care of those living with this disease by evaluating multiple
interferon-free regimens," said
Advancing Development of Two Nucleotide Polymerase Inhibitors
As part of a broad strategy to develop interferon-free regimens, Vertex
and its collaborator Alios BioPharma are conducting Phase 1 studies of
two structurally-distinct nucleotide polymerase inhibitors, known as
ALS-2200 and ALS-2158. Vertex announced today that it has begun the
first 7-day viral kinetic studies of ALS-2200 and ALS-2158 in people
with genotype 1 hepatitis
ZENITH is an ongoing Phase 2 study that enrolled 152 people with
genotypes 1a and 1b chronic hepatitis C who had not been previously
treated to evaluate multiple response-guided treatment regimens with
VX-222, Vertex's non-nucleoside polymerase inhibitor in development, in
different combinations with INCIVEK, Pegasys® (pegylated-interferon
alfa-2a) and Copegus® (ribavirin), three medicines approved
to treat hepatitis
About INCIVEK and VX-222
INCIVEK ® (telaprevir) tablets is an oral medicine that acts
directly on the hepatitis C virus protease, an enzyme essential for
viral replication. INCIVEK is the most prescribed direct-acting
antiviral for the treatment of adults with genotype 1 chronic hepatitis
C and has been used to treat more than 25,000 people in
INCIVEK was approved by the
Vertex developed telaprevir in collaboration with Tibotec BVBA and
Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir
VX-222 is an oral medicine in development that is a non-nucleoside inhibitor of the HCV NS5B polymerase. Vertex has worldwide commercial rights for VX-222.
About ALS-2200 and ALS-2158
ALS-2200 and ALS-2158 are nucleotide analogues that appear to have a
high barrier to drug resistance based on non-clinical and in vitro
studies. Both compounds are designed to inhibit the replication of the
hepatitis C virus by acting on the NS5B polymerase. Each compound is
structurally distinct (adenosine and uracil) 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 INCIVEK 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 vitro studies of 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
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
Vertex's press releases are available at www.vrtx.com.
Special Note About 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 sixth paragraph of this press release and
statements regarding (i) Vertex's plan to start a Phase 2b study in Q3
2012 to evaluate this interferon-free combination regimen in a total
treatment duration as short as 12 weeks; (ii) Vertex's plan to advance
its broad portfolio of direct acting antivirals; (iii) the company's
intent to pursue a Phase 2b study evaluating multiple interferon-free
combination regimens and the potential design of this study; (iv) the
company's plan to use data from the Phase 2b study to design a Phase 3
program with the goal of submitting an NDA for its first interferon-free
regimen by the end of 2014 or beginning of 2015; and (v) the data that
the company expects to receive from ongoing studies of ALS-2200 and
ALS-2158 in the second quarter of 2012 and the possible initiation of
Phase 2 studies involving ALS-2200 and/or ALS-2158 in the second half of
2012. 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 interim data
presented in this press release may not be predictive of the final
outcomes from this clinical trial; the outcomes from any future clinical
trials of VX-222, ALS-2200 and/or ALS-2158 may not be favorable and the
other risks listed under Risk Factors in Vertex's annual report and
quarterly reports filed with the
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.
(VRTX - GEN)
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.
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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).
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