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Vertex New HCV Drugs/Studies Update
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Vertex Pharmaceuticals Reports Third Quarter 2009 Financial Results and Highlights Recent Business and Clinical Progress
Mon Oct 26, 2009 4:01pm EDT
-Phase 3 registration programs in hepatitis C and cystic fibrosis on track-
-Vertex to present telaprevir SVR data from Study C208 at AASLD meeting this week-
CAMBRIDGE, Mass.--
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reviewed recent business and clinical progress and reported consolidated financial results for the quarter ended September 30, 2009.
"Vertex has made significant advancements across its business and expects to enter 2010 in a strong financial position that will enable the continued investment in late-stage development programs in hepatitis C virus infection and cystic fibrosis," said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex Pharmaceuticals. "We remain focused on the completion of the telaprevir Phase 3 registration program and are on track to submit a telaprevir New Drug Application in the second half of 2010. In addition, we believe ongoing clinical trials of telaprevir and of our novel HCV polymerase inhibitor VX-222 will enable the initiation of the first combination trial of these two compounds in HCV patients in the coming months - underscoring our commitment to improve
patient care in HCV."
Mr. Emmens continued, "Later this week, we expect to present final SVR data from Study C208 at the AASLD meeting in Boston showing the potential for telaprevir to be dosed twice-daily as part of a response-guided treatment regimen. Our confidence in telaprevir`s competitive profile remains high, and we look forward to the presentation of data from C208 and other clinical trials in the coming days.
"In cystic fibrosis, we recently completed enrollment in a Phase 2 trial of VX-809, our novel CFTR corrector compound, and we continue to enroll patients across the three trials of the Phase 3 registration program for VX-770, our
novel CFTR potentiator. VX-770 and VX-809 aim to address the underlying defective protein responsible for this orphan disorder, with the goal of enabling cystic fibrosis patients to live a more normal life," Mr. Emmens said.
Broad Commitment to Hepatitis C
Phase 3 registration program ongoing: ADVANCE, ILLUMINATE and REALIZE trials
* The ADVANCE, ILLUMINATE and REALIZE trials are evaluating telaprevir-based regimens as part of a global Phase 3 registration program in more than 2,200 genotype 1 treatment-naïve and treatment-failure patients with hepatitis C virus (HCV) infection.
* Vertex expects sustained viral response (SVR) data to become available from ADVANCE and ILLUMINATE in the first half of 2010 and from REALIZE in mid-2010. Vertex plans to submit a New Drug Application (NDA) for telaprevir in the second half of 2010.
* The Phase 3 ADVANCE trial is evaluating telaprevir, or placebo, as part of a 24-week telaprevir-based response-guided treatment regimen in combination with pegylated interferon (peg-IFN) and ribavirin (RBV) in more than 1,050 treatment-naïve HCV patients. The response-guided trial design is utilizing rapid viral response (RVR) criteria to determine which telaprevir patients can stop all treatment at 24 weeks.
* The Phase 3 ILLUMINATE trial is evaluating response-guided telaprevir-based regimens, or placebo, in more than 500 treatment-naïve HCV patients. This trial is designed to supplement SVR data obtained from the pivotal Phase 3 ADVANCE trial. The aim of the ILLUMINATE trial is to characterize whether there is an additional benefit to extending treatment from 24 to 48 weeks in treatment-naïve
patients who achieved undetectable virus levels at weeks 4 and 12 of treatment (eRVR).
* The Phase 3 REALIZE trial is evaluating 48-week telaprevir-based regimens, or placebo, in more than 650 patients with genotype 1 HCV who did not achieve an
SVR with a previous peg-IFN-based treatment. The REALIZE trial enrolled all major treatment-failure groups, including null responders.
SVR data from telaprevir twice-daily dosing to be presented at AASLD this week
* Vertex expects that final SVR data from Study C208, which is evaluating twice-daily telaprevir dosing, will be presented at a Presidential Plenary session at the upcoming Annual Meeting of the American Association for the Study
of Liver Diseases (AASLD), Oct. 30 - Nov. 3 in Boston. The C208 presentation at AASLD represents the first SVR data for telaprevir-based regimens, including SVR results from twice-daily dosing of telaprevir, as part of a response-guided therapy trial design, similar to that being used in the ADVANCE and ILLUMINATE Phase 3 trials of telaprevir. Study C208 is an exploratory Phase 2, open-label
clinical study conducted by Tibotec in Europe that evaluated a twice-daily (1125mg q12h) dosing schedule of telaprevir in combination with peg-IFN-alfa-2a (PEGASYS¨) or peg-IFN-alfa-2b (PEGINTRON¨) and RBV, as compared to the current three-times-daily (750mg q8h) telaprevir dosing schedule.
Additional telaprevir clinical studies in patients who failed prior HCV therapy
* Vertex has completed PROVE 3, a Phase 2b clinical trial of telaprevir-based combination therapy in patients with genotype 1 HCV who did not achieve an SVR with a previous peg-IFN-based treatment. Final PROVE 3 data, including 48-week follow-up SVR rates (SVR48), will be presented at AASLD.
* Vertex is also conducting Study 107, an open-label Phase 2 study to evaluate telaprevir-based combination regimens in patients who did not achieve an SVR in the 48-week control arms of the PROVE 1, PROVE 2 and PROVE 3 studies. In Study 107, telaprevir was given in combination with peg-IFN and RBV for 12 weeks followed by peg-IFN and RBV for 12 weeks or 36 weeks depending on the patient`s antiviral response to telaprevir in Study 107 and whether the patient was a prior null-responder, partial-responder or relapser.
On track to initiate STAT-C combination trial as early as Q4 2009
* Vertex is seeking to advance HCV therapy through the development of novel combinations of Specifically-Targeted Antiviral Therapies for hepatitis C (STAT-Cs).
* Vertex is currently conducting a three-day, multiple-dose viral kinetic study to evaluate the antiviral activity, safety, tolerability and pharmacokinetics of the HCV polymerase inhibitor VX-222. In the trial, VX-222 is being administered at four different doses as a monotherapy in 32 treatment-naïve patients with genotype 1 HCV infection. Vertex is also currently conducting a drug-drug interaction study with VX-222 and telaprevir in healthy volunteers.
* Vertex expects to obtain data from these trials in the fourth quarter of 2009, which could enable the initiation of a combination trial of telaprevir and VX-222 in patients with genotype 1 HCV as early as the fourth quarter of 2009.
Vertex expects data from this first STAT-C combination study of telaprevir and VX-222 to become available by mid-2010.
Additional HCV compounds in clinical development
* Vertex is also evaluating additional HCV compounds, including the HCV protease inhibitors VX-813 and VX-985 as well as the HCV polymerase inhibitor VX-759.
* Vertex also has an NS5A inhibitor program in preclinical development.
* The goal of these programs is to identify compounds that are appropriate for further development, including combination therapy.
AASLD
* The upcoming AASLD meeting, being held Oct. 30 - Nov. 3 in Boston, is expected to include three telaprevir-related clinical presentations, including presentations on SVR results from Study C208, final SVR48 results from PROVE 3
and results from a pooled analysis of PROVE 1 and PROVE 2 in "difficult-to-cure" patients.
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