Vertex ready to launch full phase 2 study of VX-950

By Jennifer Lanning Drey

Eugene, Ore., May 17 - Vertex Pharmaceuticals Inc. is poised to embark on a major phase 2 study of VX-950, an investigational oral hepatitis C virus protease inhibitor, said Ian Smith, executive vice president and chief financial officer for Vertex, during a presentation at the Bank of America 2006 Health Care Conference on Wednesday.

"This study has the potential to establish the clinical profile of VX-950," Smith said during the conference.

The upcoming major phase 2 program will involve approximately 700 naïve and treatment failure patients with durations of treatment ranging from three to 12 months. Vertex expects that the study will help determine the optimal duration needed to achieve the optimal viral response rate, Smith said.

The expanded phase 2 study will also help to establish a future timeline for VX-950. Smith said Vertex is on track to file a New Drug Application for the compound in 2008.

"This is a major advancement for the company and for the drug toward its end objective of being a transformational therapy," he said at the health care conference.

Vertex announced in April that data from a phase 1b clinical trail had shown that when VX-950 was dosed with pegylated interferon alfa-2a (Pegasys or peg-IFN), the combination was well-tolerated and achieved a dramatic reduction in plasma viral RNA levels in patients with chronic genotype 1 hepatitis C infection through 14 days of dosing.

In early 2006, Vertex reported preliminary results from a 28-day phase 2 study of VX-950 dosed in combination with peg-IFN and ribavirin. In the study, 12 of 12 patients had plasma hepatitis C RNA levels below the limit of detection at 28 days, officials said.

Vertex also announced on Wednesday that it has initiated a phase 1 clinical study for VX-770, an oral drug candidate that specifically targets a key mechanism underlying cystic fibrosis. The study will evaluate the safety, tolerability and pharmacokinetics of escalating single and multiple doses of VX-770 in healthy volunteers and will evaluate single doses in patients with cystic fibrosis, according to a company news release.

Vertex is a Cambridge, Mass., biotechnology company that develops small molecule drugs for viral diseases, inflammation, autoimmune diseases and cancer.

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