Biotech Values

[DewDiligence]

VRTX Reports Data from Phase-2 Telaprevir Study with BID Dosing

[The important outcome from this study is that BID Telaprevir dosing was as safe and effective as TID dosing; if borne out in additional studies, this removes one of the major drawbacks of Telaprevir relative to other HCV protease inhibitors. A notable secondary outcome is that Pegasys was superior to Pegintron in the rate of RVR regardless of whether Telaprevir was dosed BID or TID. Although the Pegintron arms ended up showing similar SVR rates as the Pegasys arms, a higher percentage of Pegintron patients required 48 weeks rather than 24 weeks of treatment to achieve an SVR. CC Sunday evening at 7pm ET to discuss these results.]

http://finance.yahoo.com/news/More-than-80-of-Hepatitis-C-bw-1916946408.html/print?x=0

›More than 80% of Hepatitis C Patients Treated in Study C208 Achieved an SVR with Telaprevir-Based Regimens

• 83% SVR achieved with twice-daily regimen of telaprevir dosed with PEGASYS and ribavirin

• Results highlight the use of response-guided therapy in managing treatment outcomes

• Similar safety and tolerability observed between telaprevir-based regimens dosed either twice daily or three times daily

5:30 pm EDT, Saturday October 31, 2009

BOSTON--(BUSINESS WIRE)--More than 80 percent of hepatitis C patients in each arm of the Phase 2 Study C208 achieved a sustained viral response (SVR) with a telaprevir-based regimen according to results of an intent-to-treat (ITT) analysis announced today by Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX ). The data from Study C208 will be presented in an oral presidential plenary session at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which began yesterday in Boston. Telaprevir is a hepatitis C virus (HCV) protease inhibitor being developed by Vertex Pharmaceuticals Incorporated in collaboration with Tibotec and Mitsubishi Tanabe Pharma.

Study C208 explored telaprevir-based regimens dosed either every 12 hours (q12h; twice daily) or every eight hours (q8h; three times daily) combined with either peg-IFN-alfa-2a (PEGASYS®) or peg-IFN-alfa-2b (PEGINTRON®) and ribavirin (RBV), for 12 weeks followed by an additional 12 weeks of peg-IFN and RBV in a response-guided trial design that included 161 treatment-naïve patients (intent-to-treat analysis) with genotype 1 hepatitis C virus (HCV) infection. Across the four arms, SVR rates were 82 and 83 percent in patients treated with the every 12 hour telaprevir-based regimen (PEGINTRON and PEGASYS, respectively) and 81 and 85 percent in patients treated with the every 8 hour regimen (PEGINTRON and PEGASYS, respectively). For the majority of patients, these SVR rates were obtained with a 24-week telaprevir-based regimen [more so in the Pegasys arms than in the Pegintron arms].

“With high SVR rates and similar safety outcomes between the twice-daily and three-times-daily treatment groups, the results from this exploratory study support the future evaluation of telaprevir-based regimens dosed twice daily,” said Professor Patrick Marcellin, M.D., from Beaujon Hospital in Clichy, France. “These results also highlight the potential future role for response-guided therapy with the goal of improving treatment outcomes and potentially shortening the duration of therapy for the majority of patients.”

[I reformatted the table below for enhanced readability.]

 
 Study Arm                           RVR*         SVR**   . 
 TID Telaprevir + Pegasys   (n=40)   83% (n=33)   83% (n=33)   
 TID Telaprevir + Pegintron (n=39)   67% (n=26)   82% (n=32)   
 BID Telaprevir + Pegasys   (n=40)   80% (n=32)   85% (n=34)   
 BID Telaprevir + Pegintron (n=42)   69% (n=29)   81% (n=34)   
  
 *Rapid Viral Response: Undetectable HCV at week 4.  
 **Sustained Viral Response: Undetectable HCV 24 weeks 
 after end of treatment 

About Study C208

Study C208 was an exploratory, four-arm, randomized, open label, Phase 2 clinical trial that was conducted by Tibotec in Europe in 161 treatment-naïve patients with genotype 1 HCV infection. The objective of Study C208 was to explore the safety, efficacy, tolerability and pharmacokinetics of telaprevir administered every 12 hours (1125mg) or every eight hours (750mg). Each dosing regimen of telaprevir was studied in combination with either peg-IFN-alfa-2a (PEGASYS) or peg-IFN-alfa-2b (PEGINTRON) and ribavirin (RBV), the currently approved therapies for chronic HCV infection. The Study C208 results being presented at AASLD represent the first SVR results for response-guided therapy in treatment-naïve patients with telaprevir-based regimens.

The C208 study protocol stipulated that patients who achieved a rapid viral response (RVR) at week 4 and who maintained undetectable HCV RNA (<25 IU/mL, undetectable Roche COBAS TaqMan HCV test) through to week 20, were able to stop all treatment at the 24-week time point and were followed six-months post-treatment to evaluate whether they achieved an SVR. Patients who did not meet the response-guided criterion were assigned to receive a total of 48 weeks of peg-IFN and RBV therapy. Eighteen percent of patients across the treatment arms were required to continue treatment up to week 48. Low rates of viral relapse (defined as patients who achieved undetectable HCV RNA at the completion of treatment, but relapsed during post-treatment follow up) were observed in patients who completed their assigned regimen (3%). Six percent of patients experienced viral breakthrough (defined as a > 1 log10 increase in HCV RNA from nadir, or HCV RNA > 100 IU/mL in patients whose HCV RNA had previously become undetectable) during the telaprevir dosing period, in line with rates reported from previous Phase 2 studies.

The frequency and severity of adverse events (AEs) and the rate of treatment discontinuations were similar to those reported in prior telaprevir trials. The most common adverse events reported in patients in Study C208 were pruritis, nausea, rash, anemia, flu-like illness, fatigue and headache, and were similar overall between the patient groups receiving every 8 hour dosing and those receiving every 12 hour dosing. Serious AEs leading to permanent treatment discontinuation of all drugs occurred in 8 out 161 patients (5%) and were mainly related to rash (3%, 4/161) and anemia (2%, 3/161).

Webcast at 7:00 p.m. ET on Sunday, November 1, 2009

Vertex intends to provide a live webcast of its investor presentation from Boston beginning at 7:00 p.m. ET on Sunday, November 1, 2009. The presentation may be accessed from the 'Events and Presentations' link on the home page of Vertex's website at www.vrtx.com. A replay of the webcast will also be available on the Company's website until November 16, 2009. To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast.‹