Vertex Shows Success in Hepatitis C Interim Data (VRTX)

June 9, 2008 · Filed Under General 

Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) is seeing shares rise pre-market on new data regarding its Genotype 1 Hepatitis C treatment.  Vertex’s PROVE 3 is an ongoing Phase IIb study evaluating telaprevir-based treatment in patients with genotype 1 chronic hepatitis C virus infection who did not achieve sustained virologic response with at least one prior regimen. Vertex is developing telaprevir in collaboration with Tibotec.

Here is a brief summary of the statistics without going deep into medical details:

  • 52% SVR 12 rate for a 24-week Telaprevir-based Regimen in patients who failed prior treatment efforts;
  • 73% of prior relapsers achieved SVR12 with 24-week telaprevir-based treatment;
  • 41% of prior non-responders achieved SVR12 with 24-week telaprevir-based regimen.

Adverse events in interim analysis were similar to those commonly observed with peg-IFN and RBV including fatigue, nausea, rash, headache, gastrointestinal disorders and anemia, and were consistent with those previously reported in patients being treated with telaprevir-based therapy in the PROVE 1 and 2 studies in treatment-naïve subjects.

Vertex and Tibotec plan to initiate a Phase III clinical trial in patients who have failed prior treatment with peg-IFN and RBV. Telaprevir (TVR) is the most advanced HCV protease inhibitor in clinical development targeting treatment of chronic hepatitis C, and is in Phase 3 clinical development in treatment-naïve patients. Hepatitis C is a disease that afflicts more than 3 million people in the United States alone, and 170 million worldwide.

PROVE 3 is a randomized, double-blind, placebo-controlled Phase IIb study that enrolled patients who failed prior treatment with peg-IFN and RBV. Patients enrolled in PROVE 3 included prior non-responders, prior relapsers and prior breakthroughs to peg-IFN and RBV treatment. The interim analysis included 453 patients that were enrolled and received at least one dose of study drug.

Vertex close dat $32.24 Friday and shares were down at $28.00 5 days ago.  Shares are now trading up over $35.00 in pre-market trading and its 52-week trading range is $13.84 to $41.42.

Jon Ogg
June 9, 2008

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