Vertex announces new phase III trial
A speedier-than-expected regulatory filing for Vertex Pharmaceuticals' hepatitis C drug appears less likely after the company disclosed plans on Monday for a new phase III study of the drug.
Investors have been hoping that Vertex and partner Johnson & Johnson could seek regulatory approval for telaprevir in 2009 based on data from existing clinical trials in treatment-resistant patients. However, the companies posted details of a new phase III study of telaprevir in treatment-resistant hepatitis C patients on the ClinicalTrials.gov Web site on Monday. The disclosure dampened investor outlook for a quick telaprevir filing.
If Vertex cannot file telaprevir with the U.S. Food and Drug Administration in 2009, the filing will likely come in the second half of 2010 after studies of the drug in treatment-naïve hepatitis C patients are completed.
"We have learned that telaprevir's phase III study in treatment experienced hepatitis C patients is different from PROVE 3 and study 107, which in our view decreases the chances of an early filing," wrote Citibank analyst Yaron Werber in a note to clients Monday evening. PROVE 3 and study 107 refer to the existing telaprevir studies in treatment-resistant patients
.Vertex spokesman Michael Partridge says Monday's disclosure of a new phase III telaprevir study is in line with the company's previous guidance and "not closely connected to a possible [FDA] filing based on PROVE 3 results."
Partridge added that Vertex and the FDA are still discussing the previously disclosed PROVE 3 data, but that "initiation of a new phase III study is a natural extension of the PROVE 3 results which we would have started no matter the path to a filing."
The new phase III study disclosed on Monday will test two different regimens of telaprevir in patients who previously did not respond to conventional hepatitis C treatment with pegylated interferon and ribavirin.
The study differs from previous studies in that patients will be treated with two regimens of telaprevir for a full 48 weeks instead of the accelerated 24-week treatment cycle used for treatment-naïve patients.
In addition, one of the arms of the new study will see whether a "lead-in" treatment with interferon and ribavirin alone before dosing of telaprevir may improve overall cure rates.
The design of the new study is sufficiently different from the previous PROVE 3 and study 107 trials to suggest that regulators want more and different data on telaprevir's effect on treatment-resistant patients before considering the drug for approval.
(adapted from article at thestreet.com)
Trial details including UK centres
There are 5 centres in the UK that will be taking part in this trial and interested patients may like to consider contacting one of the participating centers to obtain more details
Kings College Hospital, London SE5 9RS -
Imperial College Hospital, London W2 1PG
Royal London Hospital, London E1 2AT - 020 7882 7242
Royal Free Hospital, London NW3 2QG - 020 7472 6157
Queen Elizabeth Hospital, Birmingham B15 2TH
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VX-950-TiDP24-C216: A Safety and Efficacy Study in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment
ClinicalTrials.gov Identifier: NCT00703118
The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C. The participants must have failed previous treatment with pegylated interferon (Peg-INF) and ribavirin (RBV).
A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects With Chronic, Genotype 1, Hepatitis C Infection Who Failed Prior Standard Treatment
Further study details as provided by Tibotec Pharmaceuticals Limited, Ireland:
Primary Outcome Measures:
• Primary objective is to demonstrate the efficacy of telaprevir in combination with Peg-INF and RBV compared to Peg-INF and RBV in patients with chronic HCV, genotype 1, infection who failed prior treatment 24 weeks after last intake of study medication.
Secondary Outcome Measures:
• The secondary objective is to evaluate the effect of a delayed start of telaprevir on efficacy.
Detailed Description:
This is a randomized, double-blind, placebo-controlled Phase III trial with telaprevir in patients with chronic Hepatitis C Virus (HCV), genotype 1, infection who failed prior treatment with standard treatment. Standard treatment is defined as treatment with Peg-INF and RBV.
The trial is designed to compare the efficacy, safety, and tolerability of 2 regimens of telaprevir (with and without delayed start) combined with standard treatment versus standard treatment alone.
The trial will consist of a screening period of approximately 4 weeks, a 48-week treatment period, and a 24-week follow-up period.
Patients will be eligible to enroll in the trial if they (1) had an undetectable HCV (RNA) level at the end of a prior course of standard treatment but did not achieve a response (viral relapsers), or (2) never had an undetectable HCV RNA level during or at the end of a prior course of standard treatment (non-responders).
Approximately 650 patients (350 prior relapsers and 300 prior non-responders) will be randomized in a 2:2:1 ratio to one of 3 treatment groups:
Treatment group A will receive telaprevir with standard treatment for 12 weeks; followed by placebo with standard treatment for 4 weeks; followed by standard treatment for 32 weeks.
Treatment group B will receive placebo with standard treatment for 4 weeks; followed by telaprevir with standard treatment for 12 weeks; followed by standard treatment for 32 weeks.
Treatment group C will receive placebo with standard treatment for 16 weeks; followed by standard treatment for 32 weeks.
In both telaprevir regimens (A and B), patients will receive 12 weeks of 750 mg of telaprevir every 8 hours along with 48 weeks of standard treatment.
Telaprevir or placebo will be given by mouth at a dose of 750 mg every 8 hours for 16 weeks. Peg-INF will be given as an injection under the skin at a dose of 180 mcg once every week for 48 weeks. RBV will be given by mouth at a dose of either 1000 or 1200 mg (depending on your body weight) two times per day for 48 weeks.
Eligibility
Ages Eligible for Study: 18 Years to 70 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
• Patient must have chronic hepatitis C infection (genotype 1) with HCV RNA level >= 1000 IU/mL
• Patient must have failed at least 1 prior course of Peg-IFN/RBV therapy (standard treatment)
• Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication
Exclusion Criteria:
• Patient is a previous non-responder that is classified as a viral breakthrough case
• Patient is infected with Hepatitis C virus, genotype 1, exhibiting more than one subtype
• Patient has Hepatitis C virus, genotype 1, and exhibits co-infection with any other genotype
• Evidence of decompensated liver disease
• Patient has condition that requires use of systemic corticosteroids
Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703118
